Caring for healthcare professionals: improving prevention in occupational healthcare Ketelaar, Sarah

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1 UvA-DARE (Digital Academic Repository) Caring for healthcare professionals: improving prevention in occupational healthcare Ketelaar, Sarah Link to publication Citation for published version (APA): Ketelaar, S. M. (2014). Caring for healthcare professionals: improving prevention in occupational healthcare General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam ( Download date: 19 Jan 2018

2 Caring for HEALTHCARE PROFESSIONALS IMPROVING PREVENTION IN OCCUPATIONAL HEALTHCARE Sarah M. Ketelaar

3 The studies described in this thesis were carried out at the Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Parts of the research in this thesis were financially supported by Instituut Gak and The Netherlands Organisation for Health Research and Development (ZonMw). Cover design and lay-out Promotie In Zicht, Arnhem Printing Ipskamp Drukkers BV, Enschede ISBN S.M. Ketelaar, All rights reserved. No part of this thesis may be reproduced in any form without the author s permission.

4 Caring for healthcare professionals: improving prevention in occupational healthcare ACADEMISCH PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam op gezag van de Rector Magnificus prof. dr. D.C. van den Boom ten overstaan van een door het college voor promoties ingestelde commissie, in het openbaar te verdedigen in de Agnietenkapel op woensdag 5 november 2014, te 14:00 uur door Sarah Molly Ketelaar geboren te Smallingerland

5 Promotiecommissie Promotores: Copromotor: Overige leden: Prof. dr. J.K. Sluiter Prof. dr. M.H.W. Frings-Dresen Dr. K. Nieuwenhuijsen Prof. dr. A.J. van der Beek Prof. dr. M.A. Grootenhuis Prof. dr. R.J. de Haan Prof. dr. A.J. Pols Prof. dr. W. van Rhenen Faculteit der Geneeskunde

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8 CONTENTS Chapter 1 General introduction 9 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Exploring novice nurses needs regarding their work-related health: a qualitative study The Mental Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals Mental Work - a workers health surveillance mental module for nurses and allied health care professionals: process evaluation of a randomized controlled trial Mental Work: the effectiveness of a mental module for workers health surveillance for nurses and allied health professionals, comparing two approaches in a cluster-randomised controlled trial Effect of an e-mental health approach to workers' health surveillance versus control group on work functioning of hospital employees: a cluster-rct Improving work functioning and mental health of healthcare employees using an e-mental health approach to workers health surveillance: pretest-posttest study Comparative cost-effectiveness of two interventions to promote work functioning by targeting mental health complaints among nurses: pragmatic cluster randomised trial Chapter 9 General discussion 191 Summary 211 Samenvatting 219 About the author 229 Curriculum vitae 231 Portfolio 232 Publications 234 Dankwoord 237

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10 1 GENERAL INTRODUCTION

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12 General introduction Work, workers health, and work functioning Work represents an important aspect of life for a large part of the world s population. It offers many benefits, including earning a living, playing a role in society, giving structure to one s day and life, and social interaction. 1 Just consider, when meeting someone, one of the first things you ask is what the other does for a living. Not being able to answer that question can be painful. However, work can also have adverse effects on the health of workers. In Europe, substantial numbers of workers are involved in accidents at work, experience work-related health problems or develop occupational diseases. 2 Additionally, 41% and 28% of European workers reported being exposed to risk factors that affect physical health and mental well-being, respectively. 2 These figures are similar to those in the Dutch working population. 3 Furthermore, work-related risk factors are associated with health problems Work-related health problems can be considered as the consequence of a misfit between job demands and the individual s abilities to meet these job demands. 7 Some important elements of work-related personal abilities are physical strength and endurance, cognitive functioning and psychological resilience. In addition, contextual resources, such as support from the supervisor or colleagues or the availability of personal protective equipment or ergonomic equipment that can help minimise the risks of job demands, are of importance to balance personal abilities with job demands. The first step in preventing work-related health problems would be to try eliminating the health risk at work. However, some jobs involve dealing with specific job demands, defined by Sluiter as job demands that exceed exposure safety levels or human capacities to meet such demands on a daily basis, leading to increased risk of work-related health problems. 8 These specific job demands can often not be changed to eliminate or minimise health risks. For workers in these so-called high-demand jobs, interventions to prevent work-related health problems could be targeted towards increasing personal abilities to deal with the job demands. Naturally, the negative consequences of work for workers health should be minimised if only for the good of the workers. However, another important reason to keep workers as healthy as possible, is that health problems often lead to negative outcomes such as suboptimal functioning at work, 9 absenteeism, 10 presenteeism, 11 productivity losses, 12 and higher costs for employers and the society as a whole In addition, suboptimal work functioning may have additional negative consequences for the health and safety of others, for instance when working in healthcare. 11

13 CHAPTER 1 Healthcare professionals work-related health One large occupational group in healthcare is formed by hospital nurses. Nursing is a high-demand job, with specific physical job demands such as lifting patients, working in shifts, and working with patients with infectious diseases. Specific psychological job demands are for instance high workload, supporting patients and their family, dealing with workplace aggression, and dealing with errors. The combination of both high workload and heavy physical work is more often seen in the healthcare sector, compared to other occupational groups. 3 Furthermore, health problems are not uncommon among nurses, 16 such as low back pain and other musculoskeletal disorders, skin complaints, 20 and mental health complaints Allied health professionals such as physiotherapists, occupational therapists and radiographers, who form another large group of healthcare professionals, have many job demands in common with nurses and appear to also experience similar work-related health problems Sickness absence and work-related absence in the healthcare and welfare sector is higher than the Dutch national average. 27 Moreover, healthcare professionals with mental health problems show suboptimal work functioning that can have additional negative consequences for the nurses themselves and their patients. For example, a study by Gärtner and colleagues showed that impaired mental health in nurses and allied health professionals affects several aspects of their work functioning, including cognitive aspects (e.g. staying alert) and causing incidents at work. 28 Furthermore, depression has been associated with presenteeism - defined as reduced productivity at work due to health problems -, which in turn has been associated with patient falls, medication errors, and lower self-reported quality of care. 29 In addition, more burnout complaints have been associated with sustaining a sharps injury more often. 30 These findings underline the importance of paying attention to the health and work functioning of nurses and allied health professionals, to sustain their health and to enable them to remain healthy and well-functioning in their profession until retirement age. In the Netherlands, the demand for healthcare and the intensity of healthcare is expected to increase in the years ahead, 27 further indicating that those who are already working in the healthcare sector should be kept healthy and well-functioning at work. Therefore, the occupational group of nurses and allied health professionals forms the focus of attention in this thesis. Occupational healthcare Prevention of work-related health problems and suboptimal work functioning falls within the field of occupational healthcare. According to the World Health Organization (WHO), occupational health deals with all aspects of health and safety in the workplace and prevention should be given priority, because the workplace should not be detrimental to health and well-being. 31 The WHO has drawn up good practices for occupational health services. In this report, it is stated that the occupational health services are required to give expert advice to 12

14 General introduction employers, individual workers and their representatives, and to carry out essentially preventive functions, while the responsibility for workers safety and health rests with the employer, or as it is organised in the Netherlands with the employer in collective agreement with employees. 32 The preventive functions to be carried out by occupational health services should be aimed at 1) establishing and maintaining a healthy and safe work environment; 2) maintaining a well-performing and motivated workforce; 3) preventing work-related disease and accidents; and 4) maintaining and promoting the work ability of workers In the Netherlands, employers are required by law to pursue an occupational health and safety policy which is targeted towards optimal occupational health and safety. 33 This entails several obligations, including performing a so-called risks inventory and evaluation (RI&E), which means that the work-related risks of the job for the workers are identified and evaluated. In addition, employers are required to periodically offer their employees the opportunity to undergo a medical examination targeted towards preventing or limiting the risks for the employees health that flow from the work that they perform. Generally, employees are free to make use of this offer but are not required to take part. However, for some jobs with specific job demands and in which impaired health of the worker may have safety risks for third parties, participation in this periodic examination is required, but only if this is defined by law or in the collective labour agreement of the occupational sector. This has not been established for healthcare occupations. In general, the actual execution of preventive activities in occupational healthcare in the Netherlands leaves much to be desired. Support and return-to-work of employees on sick leave form the major part of the work performed by Dutch occupational health services, while occupational physicians wish to spend more time performing preventive activities. 34 Improving prevention in occupational healthcare Disease prevention can be classified according to the targeted group. 35 When adapted to occupational health, this classification leads to four types of prevention in the workplace: Universal prevention targeting all workers, to decrease health risks and improve workers health: for example offering all hospital employees a lifestyle intervention to help maintain a healthy weight. 36 Selective prevention targeting groups of workers at risk, to improve their health: for example offering nurses a patient care ergonomics program to prevent injuries associated with patient handling. 37 Indicated prevention targeting individual workers at high risk or with early symptoms of health problems, to prevent development of health problems or further worsening of health: for example offering skin care education and individual counselling to healthcare professionals with hand eczema in order to decrease the severity of their hand eczema and to improve quality of life

15 CHAPTER 1 Care-related prevention targeting individual workers with existing health problems, to reduce the burden of these health problems and additional complications and to support self-management: for example offering coaching to workers with a chronic illness to help them manage the challenges of working with an illness. 39 How should prevention in occupational healthcare for healthcare professionals be organised, to support them to stay healthy and well-functioning at work? Ideally, prevention of work-related health problems and suboptimal work functioning due to health problems is introduced as early as possible. Several studies have shown that work-related health problems are already prevalent in nursing students and newly qualified nurses Consequently, to indeed prevent nurses from developing work-related health problems, they should be offered support from starting off training in clinical work, i.e. when they are still a nursing student. However, novice nurses needs regarding occupational health support are unknown. Therefore, the first part of this thesis is focused on identifying novice nurses needs to keep them healthy and well-functioning in their job, i.e. how selective prevention for this occupational group should be designed. The identified needs can be used to develop a comprehensive prevention programme, to make sure that the nurses whom we so urgently need to meet the continuing and increasing healthcare demands, are well cared for themselves. Workers health surveillance As discussed above, one method to engage in preventive occupational healthcare is a periodical examination targeted towards preventing or limiting the risks for the employees health that flow from the work that they perform. A promising tool to perform this periodic examination is workers health surveillance (WHS). According to the International Labour Organization (ILO), WHS should be an essential component of programmes aimed at the protection of employees. 43 In the Netherlands, a guideline for developing WHS has been drawn up. 44 In this guideline for occupational physicians, three aims for WHS have been defined: It should prevent work-related health problems in individual and groups of employees; It should monitor and promote work-related health and work functioning of individual and groups of employees; It should monitor and improve sustained employability. An important component of WHS is that it not only detects an imbalance between job demands and personal abilities to meet these demands, but also puts interventions into action to decrease existing impairments. 44 WHS falls within the spectrum of selective, indicated and care-related prevention. It is directed towards detecting early signs of impaired health and impaired work functioning and intervening timely to prevent worsening of these impairments, making it a form of indicated prevention. In addition, as a form of care-related prevention, WHS can reveal health problems and suboptimal work 14

16 General introduction functioning and offer interventions to help healthcare professionals cope with health problems and to support them to stay well-functioning in spite of these health problems. Furthermore, interventions targeting improvement of mental health and work functioning may also increase personal abilities to better deal with the job demands, thus making it a form of selective prevention. 1 One of the quality criteria for WHS drawn up by the ILO is that WHS is relevant, meaning that it should be linked to the specific occupational hazards in the workplace, 43 calling for job-specific WHS. This also allows for tailoring interventions which are appropriate and feasible for the specific job. Several studies have paid preventive attention to healthcare professionals health, for instance by improving mental health or physical health 48 or through health surveillance of latex allergy 49 or coronary heart disease risk. 50 However, although one of the main aims of WHS is to monitor and improve work functioning, knowledge on how work functioning of healthcare professionals can be improved is scarce. To gain evidence regarding this topic, a comprehensive mental health module for WHS is researched in this thesis. This module is targeted towards hospital-employed nurses and allied health professionals, to detect early signs of mental health problems or impaired work functioning, or both. It was decided to target mental health specifically given the multifactorial psychosocial context, and since work-related psychosocial strain 27 and mental health problems form a significant problem for healthcare professionals but can also remain relatively invisible. Furthermore, healthcare professionals have difficulty asking for timely help when experiencing mental health problems, but are not offered help for mental health problems easily either. 51,52 However, in light of the possible consequences of mental health problems for quality of care and patient safety 28,29 and healthcare professionals own health and safety, 30 it is important to receive help timely. Therefore, offering this help proactively seems important. Evaluation of how WHS is received by employees, its effectiveness on work functioning and mental health outcomes and its cost-effectiveness is important to improve preventive activities in occupational healthcare. Therefore, part of this thesis is dedicated towards studying a mental health module for WHS for healthcare professionals and evaluating its effectiveness in improving work functioning and mental health. An innovative approach to workers health surveillance How should WHS be applied in order to monitor and improve healthcare professionals work functioning and mental health? In the Netherlands, it is preferable that WHS is performed by occupational physicians. The occupational physician initiates and performs the screening and subsequently offers advice and possible interventions. 44 Applying e-health might also be a useful and feasible approach to perform a mental health module for WHS. Online screening is a practical and efficient method to screen for self-reported impaired work functioning and impaired mental health. Furthermore, in recent years 15

17 CHAPTER 1 e-health is increasingly used to provide healthcare and healthcare policies have high expectations of it. For instance, it is thought that e-health can play a part in reducing the increasing costs of healthcare. 53 E-mental health (EMH) can be defined as the use of information and communication technology, and in particular the many technologies related to the Internet, to support and improve mental healthcare. 54 A variety of mental health complaints have been targeted using EMH interventions, such as depression, anxiety, phobias, and addictions Some EMH interventions are completely guided by a healthcare provider but the patient and healthcare provider only have contact through or by phone. 58 Some are complementary to traditional face-to-face therapy. 59 Others are completely unguided, in which healthcare seekers follow the intervention entirely in their own time and pace without receiving feedback from a healthcare provider. 60 Applying an EMH strategy in healthcare may have an important advantage over face-to-face healthcare or other types of guidance: self-help interventions can be followed in workers own time, at their own pace, and in a self-chosen place. 61 Furthermore, people may not seek help for mental health problems due to fear of being stigmatised 62,63 or because they are ashamed of their problems or find them difficult to talk about. As noted previously, this might especially be a problem for healthcare professionals who experience mental health problems. 51,52 In the workplace, this reluctance to seek help may especially hold, as it is conceivable that employees do not want their employer to find out about their problems due to fear of losing their job. Following a self-help intervention for mental health problems related to work might be helpful to receive healthcare without the work environment having to be aware of health problems. Although screening for health problems is often performed online and unguided self-help EMH interventions that have been studied in the general public have had positive outcomes for a variety of mental health aspects, no evidence is available on the effects of self-help EMH interventions on work functioning and their effects in a specific working population such as healthcare professionals. Moreover, EMH interventions have thus far only been offered as stand-alone interventions for a specific mental health complaint. In this thesis, an EMH approach to WHS is evaluated, consisting of: 1. Online screening of impaired work functioning and impaired mental health; 2. Online personalised feedback on screening results; and 3. a) An offer to follow a tailored choice of self-help courses (EMH interventions) b) In case of impaired work functioning an educational leaflet with stepwise advice on how to improve work functioning. The choice of self-help courses that employees received was tailored to the specific complaints as indicated by the individual s screening results. This innovative EMH approach to WHS is compared to a more conventional approach to WHS as well as to a 16

18 General introduction control group. In the more conventional approach to WHS, screening and feedback were followed by a preventive consultation with an occupational physician. The evaluation of these two different approaches forms a large part of the research in this thesis. In Figure 1, a conceptual model is presented in which the two main elements that are studied in this thesis are pictured. Working as a healthcare professional involves dealing with certain job demands which may lead to consequences for the healthcare professional s health. This link is moderated by personal abilities to deal with the job demands, which is in turn influenced by available resources. Subsequently, health problems in combination with unchanged job demands may lead to impaired work functioning. In addition, impaired work functioning may be of additional influence on the healthcare professional s health. Occupational health support for novice nurses may be aimed towards increasing their personal abilities to deal with their job demands or increasing available resources. In addition, it may help to prevent negative consequences of job demands for the nurses health, as well as help the nurse function optimally in spite of health problems. Novice nurses needs for occupational health support have been identified as part of this thesis. Furthermore, a job-specific mental health module for WHS is studied to gain evidence on which approach might improve mental health and work functioning of healthcare professionals. 1 Occupational health support needs early in career Resources Personal abilities to deal with job demands Job demands Health Work functioning Workers health surveillance mental health module Figure 1 Conceptual model of preventive occupational healthcare for healthcare professionals studied in this thesis. relation between concepts; researched in this thesis. 17

19 CHAPTER 1 THESIS OBJECTIVE AND RESEARCH QUESTIONS In summary, working in healthcare involves meeting high job demands, which can have serious consequences for healthcare professionals health and work functioning and their patients safety. Therefore, attention should be paid to the prevention of work-related health problems and impaired work functioning. With appropriate help or interventions, healthcare professionals can be supported to stay healthy and to remain well-functioning in their profession until retirement age. Therefore, this thesis has the following main objectives: A. The assessment of needs of novice nurses regarding occupational health support; and B. The evaluation of two approaches to a mental health module for job-specific workers health surveillance for nurses and allied health professionals. These objectives lead to the following research questions: 1. What are the occupational health support needs of novice nurses to keep them healthy and well-functioning in their (future) work? 2. How do nurses, allied health professionals and occupational physicians evaluate a mental health module for workers health surveillance? 3. What is the effect of an e-mental health approach to workers health surveillance on the work functioning and mental health of nurses and allied health professionals? 4. What is the cost-effectiveness regarding work functioning of two different approaches to a mental health module for workers health surveillance? 18

20 General introduction THESIS OUTLINE In Chapter 2, the results of a qualitative study on the occupational health support needs of nursing students and newly qualified nurses are presented, providing an answer to research question 1. 1 Chapter 3 describes the design of a three-armed cluster-randomised controlled trial to study the effectiveness of workers health surveillance targeting the work functioning and mental health of nurses and allied health professionals. In Chapter 4 the results of the process evaluation which was performed alongside the cluster-randomised controlled trial are presented, providing an answer to research question 2. This chapter gives insight into the extent to which the trial was performed as intended. It also focuses on the perspectives of the participants and participating occupational physicians on the workers health surveillance as performed in the trial as well as in general. Research question 3 is addressed in Chapters 5 to 7. Chapter 5 addresses the effect of an e-mental health approach to workers health surveillance compared to the more conventional approach on nurses and allied health professionals work functioning and mental health. Subsequently, Chapter 6 presents the effects of an e-mental health approach to workers health surveillance compared to a control group. Chapter 7 reports on the results of a pretest-posttest study, giving more insight into the effects of the e-mental health approach in a larger sample of fully participating nurses and allied health professionals. The cost-effectiveness of both approaches to workers health surveillance, dealing with research question 4, is described in Chapter 8. Chapter 9, in closing, forms the general discussion of this thesis. Here, the main findings of the thesis are interpreted. Additionally, the implications resulting from the research are described and recommendations are given for practice and research. 19

21 CHAPTER 1 REFERENCES 1 Waddell G & Burton AK. Is work good for your health and well-being? London: TSO, Eurostat. Health and safety at work in Europe ( ) - A statistical portrait. Luxembourg: Publications Office of the European Union, Kösters L. Caring professions mentally and physically burdening. Socioeconomic trends, 4th quarter [in Dutch: Verzorgende beroepen psychisch en fysiek zwaar belastend. Sociaaleconomische trends, 4e kwartaal]. Den Haag, the Netherlands: CBS, da Costa BR & Vieira ER. Risk factors for work-related musculoskeletal disorders: A systematic review of recent longitudinal studies. Am J Ind Med 2010; 53: Conard PL & Sauls DJ. Deployment and PTSD in the Female Combat Veteran: A Systematic Review. Nurs Forum 2014; 49: Dickel H, Kuss O, Schmidt A et al. Importance of irritant contact dermatitis in occupational skin disease. Am J Clin Dermatol 2002; 3: van Dijk FJH, van Dormolen M, Kompier MAJ, Meijman TF. Reappraisal of the model of work load and work capacity [in Dutch: Herwaardering model belasting-belastbaarheid]. TSG 1990; 68: Sluiter JK. High-demand jobs: age-related diversity in work ability? Appl Ergon 2006; 37: Aronsson G & Gustafsson K. Sickness presenteeism: prevalence, attendance-pressure factors, and an outline of a model for research. J Occup Environ Med 2005; 47: Davey MM, Cummings G, Newburn-Cook CV, Lo EA. Predictors of nurse absenteeism in hospitals: a systematic review. J Nurs Manag 2009; 17: Schultz AB & Edington DW. Employee health and presenteeism: a systematic review. J Occup Rehabil 2007; 17: Stewart WF, Ricci JA, Chee E, Morganstein D. Lost productive work time costs from health conditions in the United States: results from the American Productivity Audit. J Occup Environ Med 2003; 45: Hemp P. Presenteeism: at work--but out of it. Harv Bus Rev 2004; 82: Goetzel RZ, Long SR, Ozminkowski RJ et al. Health, absence, disability, and presenteeism cost estimates of certain physical and mental health conditions affecting U.S. employers. J Occup Environ Med 2004; 46: The Sainsbury Centre for Mental Health. Mental Health at Work: Developing the business case. Policy paper 8. London: The Sainsbury Centre for Mental Health, Fronteira I & Ferrinho P. Do nurses have a different physical health profile? A systematic review of experimental and observational studies on nurses physical health. J Clin Nurs 2011; 20: Failde I, Gonzalez JL, Novalbos JP et al. Psychological and occupational predictive factors for back pain among employees of a university hospital in southern Spain. Occup Med (Lond) 2000; 50: d Errico A, Viotti S, Baratti A et al. Low Back Pain and Associated Presenteeism Among Hospital Nursing Staff. J Occup Health 2013; 55: Serranheira F, Cotrim T, Rodrigues V et al. Nurses working tasks and MSDs back symptoms: results from a national survey. Work 2012; 41 Suppl 1: Cherry N, Meyer JD, Adisesh A et al. Surveillance of occupational skin disease: EPIDERM and OPRA. Br J Dermatol 2000; 142: Adriaenssens J, de Gucht V, Maes S. The impact of traumatic events on emergency room nurses: Findings from a questionnaire survey. Int J Nurs Stud 2012; 49: Mealer M, Burnham EL, Goode CJ et al. The prevalence and impact of post traumatic stress disorder and burnout syndrome in nurses. Depress Anxiety 2009; 26: Aiken LH, Clarke SP, Sloane DM et al. Nurses reports on hospital care in five countries. Health Aff (Millwood) 2001; 20: Balogun JA, Titiloye V, Balogun A et al. Prevalence and determinants of burnout among physical and occupational therapists. J Allied Health 2002; 31: Campo MA, Weiser S, Koenig KL. Job strain in physical therapists. Phys Ther 2009; 89: Ibrahim NI & Mohanadas D. Prevalence of musculoskeletal disorders among staffs in specialized healthcare centre. Work 2012; 41 Suppl 1:

22 General introduction 27 Inspectie SZW. Healthy & safe working. Sector report of Healthcare and Welfare [in Dutch: Gezond & veilig werken. Sectorreportage Zorg en Welzijn ]. Den Haag, the Netherlands: Inspectie SZW, Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: Letvak SA, Ruhm CJ, Gupta SN. Nurses presenteeism and its effects on self-reported quality of care and costs. Am J Nurs 2012; 112: Wang S, Yao L, Li S et al. Sharps injuries and job burnout: a cross-sectional study among nurses in China. Nurs Health Sci 2012; 14: World Health Organization. Workers health: global plan of action ( ), occupational_health/who_health_assembly_en_web.pdf. Accessed June World Health Organization Regional office for Europe. Good practice in occupational health services: A contribution to workplace health. Copenhagen: World Health Organization Regional office for Europe, Dutch Working Conditions Act [in Dutch: Arbeidsomstandighedenwet]. BWBR /geldigheidsdatum_ Accessed June de Zwart BCH, Prins R, van der Gulden JWJ. Investigation of the position of the occupational physician [in Dutch: Onderzoek naar de positie van de bedrijfsarts]. Leiden, the Netherlands: AStri Beleidsonderzoek- en advies, Platform Personalized Prevention. The Prevent-model for Personal Prevention [in Dutch: Het Prevent-model voor Persoonlijke Preventie]. Accessed June Thorndike AN, Sonnenberg L, Healey E et al. Prevention of weight gain following a worksite nutrition and exercise program: a randomized controlled trial. Am J Prev Med 2012; 43: Nelson A, Matz M, Chen F et al. Development and evaluation of a multifaceted ergonomics program to prevent injuries associated with patient handling tasks. Int J Nurs Stud 2006; 43: Ibler KS, Jemec GB, Diepgen TL et al. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ 2012; 345:e McGonagle AK, Beatty JE, Joffe R. Coaching for workers with chronic illness: Evaluating an intervention. J Occup Health Psychol 2014; DOI /a [Epub ahead of print]. 40 Smith DR & Leggat PA. Musculoskeletal disorders among rural Australian nursing students. Aust J Rural Health 2004; 12: Cheung K. The incidence of low back problems among nursing students in Hong Kong. J Clin Nurs 2010; 19: Rudman A & Gustavsson JP. Early-career burnout among new graduate nurses: a prospective observational study of intra-individual change trajectories. Int J Nurs Stud 2011; 48: International Labour Organization. Technical and ethical guidelines for workers health surveillance. Geneva, Switzerland: ILO, Sluiter JK, Weel ANH, Hulshof CT. Practice guideline on workers health surveillance [in Dutch: Leidraad Preventief medisch onderzoek van werkenden]. Utrecht, the Netherlands: Kwaliteitsbureau NVAB, Foureur M, Besley K, Burton G et al. Enhancing the resilience of nurses and midwives: pilot of a mindfulness-based program for increased health, sense of coherence and decreased depression, anxiety and stress. Contemp Nurse 2013; 45: Asuero AM, Queralto JM, Pujol-Ribera E et al. Effectiveness of a mindfulness education program in primary health care professionals: a pragmatic controlled trial. J Contin Educ Health Prof 2014; 34: Gunusen NP & Ustun B. An RCT of coping and support groups to reduce burnout among nurses. Int Nurs Rev 2010; 57: Letvak S. We cannot ignore nurses health anymore: a synthesis of the literature on evidence-based strategies to improve nurse health. Nurs Adm Q 2013; 37: Bollinger ME, Mudd K, Keible LA et al. A hospital-based screening program for natural rubber latex allergy. Ann Allergy Asthma Immunol 2002; 88:

23 CHAPTER 1 50 Gaetano DE, Ackerman S, Clark A et al. Health surveillance for rural volunteer firefighters and emergency medical services personnel. AAOHN J 2007; 55: Moll SE. The web of silence: a qualitative case study of early intervention and support for healthcare workers with mental ill-health. BMC Public Health 2014; 14: Joyce T, Higgins I, Magin P et al. The experiences of nurses with mental health problems: colleagues perspectives. Arch Psychiatr Nurs 2012; 26: van der Geest L, Boudeling M, Janssen W. Health online [in Dutch: Gezondheid online]. Utrecht, the Netherlands: NYFER, Riper H, Smit F, van der Zanden R et al. E-mental health. High tech, high touch, high trust. Utrecht, the Netherlands: Trimbos-instituut, Griffiths KM, Farrer L, Christensen H. The efficacy of internet interventions for depression and anxiety disorders: a review of randomised controlled trials. Med J Aust 2010; 192:S4-S Hedman E, Ljotsson B, Lindefors N. Cognitive behavior therapy via the Internet: a systematic review of applications, clinical efficacy and cost-effectiveness. Expert Rev Pharmacoecon Outcomes Res 2012; 12: Riper H, Spek V, Boon B et al. Effectiveness of E-self-help interventions for curbing adult problem drinking: a meta-analysis. J Med Internet Res 2011; 13:e Johansson R, Bjorklund M, Hornborg C et al. Affect-focused psychodynamic psychotherapy for depression and anxiety through the Internet: a randomized controlled trial. PeerJ 2013; 1:e Volker D, Vlasveld MC, Anema JR et al. Blended E-health module on return to work embedded in collaborative occupational health care for common mental disorders: design of a cluster randomized controlled trial. Neuropsychiatr Dis Treat 2013; 9: Bolier L, Haverman M, Kramer J et al. An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial. J Med Internet Res 2013; 15:e Beattie A, Shaw A, Kaur S, Kessler D. Primary-care patients expectations and experiences of online cognitive behavioural therapy for depression: a qualitative study. Health Expect 2009; 12: Spek V, Nyklicek I, Smits N et al. Internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years old: a randomized controlled clinical trial. Psychol Med 2007; 37: Cuijpers P, van Straten A, Warmerdam L, van Rooy MJ. Recruiting participants for interventions to prevent the onset of depressive disorders: possible ways to increase participation rates. BMC Health Serv Res 2010; 10: Warmerdam L, van Straten A, Twisk J et al. Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res 2008; 10:e Farrer L, Christensen H, Griffiths KM, Mackinnon A. Internet-based CBT for depression with and without telephone tracking in a national helpline: randomised controlled trial. PLoS One 2011; 6:e Riper H, Kramer J, Smit F et al. Web-based self-help for problem drinkers: a pragmatic randomized trial. Addiction 2008; 103: Blankers M, Koeter MW, Schippers GM. Internet therapy versus internet self-help versus no treatment for problematic alcohol use: A randomized controlled trial. J Consult Clin Psychol 2011; 79: Billings DW, Cook RF, Hendrickson A, Dove DC. A web-based approach to managing stress and mood disorders in the workforce. J Occup Environ Med 2008; 50:

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26 2 EXPLORING NOVICE NURSES NEEDS REGARDING THEIR WORK-RELATED HEALTH: A QUALITATIVE STUDY Sarah M. Ketelaar Karen Nieuwenhuijsen Monique H.W. Frings-Dresen Judith K. Sluiter Submitted for publication.

27 CHAPTER 2 ABSTRACT This study investigated Dutch novice nurses experiences and needs regarding occupational health support to prevent work-related health problems and to help them remain well-functioning. A qualitative interview study was conducted with six nursing students and eight newly qualified nurses. The interviews covered three topics: experiences with the link between work and health, received occupational health support, and occupational health support needs. Participants reported experiences with work-related health problems early in their career. Occupational health support needs included knowledge and psychosocial support during nursing education, e.g. through paying attention to dealing with shift work, or career counselling. Also, they reported a need for knowledge and psychosocial support at the start of their clinical placement or new job in the hospital, e.g. information from occupational health services or having a mentor. Furthermore, they reported that occupational health support requires a more general place at work through offering knowledge, e.g. tailored advice on proper lifting position; psychosocial support, e.g. a positive team atmosphere; and physical support, e.g. suitable preventive measures. 26

28 Novice nurses needs for occupational health support INTRODUCTION Recently, prevention of health problems in work settings has been given increasing attention. This form of prevention mostly targets either work-related health, e.g. prevention of sickness absence due to work stress, or employees health which is not specifically work-related, e.g. health promotion to reduce the risk of developing future health problems such as cardiovascular disease. Efforts to prevent work-related health problems usually target employees who already show a certain degree of impairment of health or work functioning. However, in an ideal situation, it would be preferable to indeed prevent work-related health problems and suboptimal work functioning. 2 Due to their nature, some jobs entail job demands which cannot be eliminated or adapted to make them less unhealthy for the employees in that job. Nursing forms one of these jobs. Working as a hospital nurse entails several work-related physical and psychosocial health risk factors including some that cannot be avoided completely, such as lifting patients, working with patients with infectious diseases, shift working, and dealing with workplace aggression. Nurses job demands may lead to health problems. 1 Furthermore, various studies have found a high prevalence of certain health problems in nurses, such as low back pain, 2 skin problems, 3 and mental health problems. 4 In the Netherlands, nursing students already start doing clinical work in their first year of nursing education. These nursing students as well as newly qualified nurses who have only just recently started working as a qualified nurse seem particularly vulnerable to developing health problems and making mistakes, precisely because they are inexperienced and therefore do not have fully developed skills yet. Additionally, they are more vulnerable because they have difficulty asking for help. 5 Previous papers have emphasised the importance of paying attention to occupational safety and health of young workers in general and of acknowledging their lack of experience. 6,7 Research has indeed shown that nursing students and newly qualified nurses do not feel sufficiently prepared for working in clinical practice. 8,9 Other studies have found a high prevalence of musculoskeletal problems 10,11 and burn-out 12,13 in novice nurses and a decline in self-reported health between the last study year and the following three years. 14 Also, nursing students are at risk of experiencing needle-stick injuries and other forms of exposure to biological material. 15,16 This alone forms an incentive to pay attention to nurses health, but health problems in nurses are also known to have effects on their work functioning, with possible consequences for patient care The British Royal College of Psychiatrists also recognises this problem and advises to set up a system to identify and tackle health problems of healthcare students early, before their work functioning is compromised

29 CHAPTER 2 All in all, it seems important to offer novice nurses occupational health support, defined as support to prevent them from developing work-related health problems and to help them to function optimally. To our knowledge, no research has focused on this kind of support for novice nurses. In addition, we have found no mention of similar support given in practice. It is unknown to what extent novice nurses are aware of the link between their job demands and their health, how they cope with this link, and how they wish to be better supported to prevent work-related health problems and to help them function optimally. Therefore, with this study we aimed to fill this gap of knowledge by investigating the following topics in novice nurses: 1. Their experiences with the link between their work and their health; 2. The occupational health support that they already receive; and 3. Their further needs for occupational health support. METHODS Context In the Netherlands, educational institutes are required to offer their students a safe work environment. In addition, the Dutch Working Conditions Act states that employers are required to periodically offer employees the opportunity to undergo an examination targeted towards preventing or limiting the risks for the employees health that flow from the work that they perform. 21 This Act also applies to students working in clinical placements. In the Netherlands, higher education nursing is taught through a regular system or through a workplace learning programme. The regular system involves attending classes full-time with a clinical placement each year for a certain number of weeks (more senior students generally have longer clinical placements). In a workplace learning programme, nursing students are employed and paid by a hospital. Every two weeks they attend classes and in the remaining time they work in a clinical placement. Every six months they change placements. Participants For our study, we aimed to interview novice nurses with little but at least some experience with clinical practice, so that they would be able to report occupational health support that they had received and to put forward occupational health support needs. This population was operationalised as 1) third or fourth year regular students in higher education, or workplace learning students in higher education; and 2) newly qualified nurses currently working as a qualified nurse and with a maximum of five years of working experience after completing their studies. 28

30 Novice nurses needs for occupational health support Participants were recruited using a range of methods such as notices on the website of an educational institute where nursing is taught, posters in hospitals, notices on internal websites of hospitals, social media messages through a professional association for nurses, and flyers at a conference for nurses in practice. We initially aimed to recruit 12 participants (three students and three newly qualified nurses working in general healthcare and three students and three newly qualified nurses working in mental healthcare) and to continue recruiting participants until no new information was being shared. To allow for refinement of the interviewing method, another two interviews were conducted. The Medical Ethics Committee of the Academic Medical Center in Amsterdam, the Netherlands, approved this study. 2 Data collection The interviews were conducted by the first author (SK) at a time and place which suited the participant. The interviews were audio-recorded and typically lasted one hour. Written informed consent was obtained from all participants. Three topics were covered during the interview using semi-structured open-ended questions (Box 1): 1. Their experiences with the link between their work and their health, to introduce the main topics of the interview. To elicit experiences, several short case descriptions were prepared and given to the participant to read during the interview when useful. 2. Occupational health support that they received. 3. Their needs for occupational health support. Box 1 Topics and subtopics of the interview. 1. Experiences with the link between work and health: a. The impact of their work on their health b. The impact of health problems on work functioning (including reasons for calling in sick) 2. Occupational health support that they received to: a. Prevent them from developing work-related health problems b. Help them to function optimally in spite of health problems 3. Occupational health support needs to: a. Prevent them from developing work-related health problems b. Help them to function optimally in spite of health problems After the interview, the first author (SK) wrote a short summary of the participants occupational health support needs and sent this to the participant to check if reported needs had been interpreted correctly. Some participants added new information when responding to this member check. 29

31 CHAPTER 2 Data analysis All audio-recorded interviews were transcribed verbatim by the first author (SK). Using the software programme MaxQDA version 11, the transcripts were analysed using a grounded theory approach, identifying themes that emerged from the data. 22 We alternated between coding earlier interviews and conducting additional interviews to allow for further exploration of new themes in subsequent interviews and to assess data saturation. Towards the last interviews, refinements of the thematic structure were made rather than new categories, indicating data saturation. During the analysis process, all transcripts were first of all open-coded to identify all important aspects that provided an answer to the research question. Two thirds of the transcripts were open-coded by both the first (SK) and second author (KN), while the remainder was open-coded by the first author (SK) only and checked by the second author (KN). In the second phase of analysis, relationships between open codes were sought and (sub)categories were formed through constant comparison. We continually reviewed codes and categories to ensure they reflected the data. In the third and final phase of analysis, main themes were formed that answered the research question. The themes and (sub)categories were discussed among all authors to increase reliability of the analysis. RESULTS Participant characteristics Six nursing students and eight newly qualified nurses applied to participate. All participants were female. Participating nursing students were aged (mean = 31, SD = 8.3), while participating newly qualified nurses were aged (mean = 29, SD = 6.1). Eleven participants studied or worked in general healthcare (mainly hospitals), two participants studied or worked in mental healthcare, and one participant worked in homecare. Working experience of newly qualified nurses after completing their studies ranged from 5 months to 5 years. Findings are presented per interview topic. Experiences with the link between work and health Work influencing health Participants had experienced various work-related health problems themselves or had seen colleagues with these problems. Aspects of the work causing health problems were physical work demands such as lifting patients and standing or walking all day; disagreeable contact with patients, patients family or colleagues; having to do a lot of 30

32 Novice nurses needs for occupational health support work in a limited time; accidents with biological material and otherwise being exposed to infectious diseases; working shifts; or making mistakes. These aspects of nursing caused various health problems, such as musculoskeletal problems; stress and worrying; anxiety; fatigue; sleeping problems; and infectious diseases such as influenza. It is notable that some participants believed that problems such as back pain are just part of the deal when working in nursing: Everyone knows, there s all this equipment that you can use, and everyone knows that it s heavy work, it s kind of part of the job. You know, you have all your equipment, but if a patient makes an unexpected movement you can t do anything but step in, and you know, it puts a strain.., it s very physical work. (ID2) 2 Health influencing work functioning Health problems were reported to lead to several forms of suboptimal work functioning, such as being unable to perform physical tasks; impaired contact with patients; lack of concentration; forgetting things and making mistakes; and being unable to respond quickly when faced with unexpected events. When asked how they decide to call in sick or not, participants reported that not wanting to infect patients is an important factor. However, they also reported feeling bad when calling in sick, as they feel they are letting their team down. One participant aptly described this dilemma: Being ill means that you have to do less, and therefore your colleagues have to do more, if we can t arrange a replacement at short notice. On the one hand, you want to work, on the other hand you don t want to work so that you don t infect the patients who have a weak immune system. (ID6) Received occupational health support As a general form of support that participants received, participants stated that they had received information at the start of their career from the occupational health services department, telling them where they could get help if they experienced problems. Other forms of support that participants received for either prevention of work-related health problems or for staying well-functioning in spite of health problems are described below. Prevention of work-related health problems To prevent them from developing work-related health problems, participants reported receiving support from a variety of sources. Peer support was often mentioned as important to be able to cope with the job demands. This peer support ranged from giving each other tips about bringing the patient s bed at the right height to facilitate lifting the patient, to giving support when dealing with patients family and the possibility to talk through things when dealing with an emotionally demanding event. Nevertheless, when 31

33 CHAPTER 2 the novice nurse makes a mistake, it can be difficult to talk about to colleagues, although others might have had similar experiences: Well, I think I sometimes keep things to myself too much. I should talk to colleagues about it more, because I constantly have this idea that I m always the one who makes mistakes. But the more you talk to colleagues about it, you hear, oh, yes, I had that once too, and then you find out that you, well, that other people also make mistakes and that you are not the only one. (ID9) Participants also reported receiving advice from professionals. For example, they reported receiving advice from occupational health and safety professionals and the hygiene and infection control department regarding preventive measures when working with patients with infectious diseases. Participants also reported receiving advice from a physiotherapist, for instance about how to improve their lifting position or about which shoes are most suitable to wear at work. Several participants mentioned that they have a colleague who also functions as an ergonomic coach in the workplace. Experiences with this ergonomic coach varied, as some participants reported receiving advice from this coach but others stated that they heard too little from him or her. Asking colleagues or their supervisor for help to deal with situations which could impact their own health was another form of occupational health support that participants received. However, asking for help can be hard because it may give the impression that the student or newly qualified nurse is not sufficiently capable. Other reasons not to ask for help were, for instance, feeling ashamed or not having the chance or the time to receive help. Participants reported existing measures to deal with incidents such as needle stick injuries (e.g. testing whether the nurse had contracted a disease or infection) or incidents of aggression as a form of occupational health support, although some participants noted that protocols on how to deal with patients with infectious diseases are not always clear. In addition, existing preventive measures were experienced as a form of support, such as protective materials, equipment for lifting or shifting patients, and protocols. However, time restraints or not knowing how to use equipment sometimes caused participants not to apply the preventive measures. One student also mentioned that her dependent position sometimes made it hard to apply preventive measures if her colleagues showed no intention of using them: Especially the slightly older nurses, I noticed, who are so used to doing it a certain way, they do it that way, and sometimes it can be difficult as a student to say yes but I want the bed to be at working height, or, you know, wait until I am completely ready for it. That can sometimes be difficult. You don t want to ( ) They have been doing it for so long, and you have just started, and then you start complaining, you know, that s a bit (ID1) 32

34 Novice nurses needs for occupational health support Additionally, a participant working in homecare mentioned that she did not want to wear protective material when working with a person with an infectious disease a whole day, because it was too warm and uncomfortable. Participants also received support through classes during nursing education in which information was given, experiences could be shared or lifting positions could be practiced. However, it was also stated that the information and opportunity to practice given in class were limited. Participants also reported receiving some education at work regarding lifting positions, safety measures, and dealing with incidents of aggression. This education was mostly given in so-called clinical lessons. 2 During their studies, participants received support from their nurse educators and their fellow students, although it was also stated that when students reported that the work was too much or that they were very tired, the teachers replied that this was part of the job and they just had to get used to it. Another participant mentioned that the people from her educational institute who could offer support were mostly hard to reach. Additionally, participants reported that the workload is distributed between colleagues, and many participants stated that it is important to know and indicate your own limits and boundaries to prevent yourself from developing health problems. Support to stay well-functioning in spite of health problems Peer support was mentioned by participants as a form of support to stay well-functioning in spite of health problems, mainly through sympathising with them or through taking their health problems into account. Another important form of support that many participants mentioned was the possibility of performing different or adapted tasks when suffering from health problems. This varied from performing completely different tasks such as administrative work or processing patient admissions to only taking care of a specific patient population, for example only patients with less need for care, no heavy patients or no dying patients. One participant who had lost a close family member not long before said: A few months ago I didn t need to take care of patients who were dying, I said it still really troubles me, it really makes me think of my father for example, then I really didn t have to do it. That s very much taken into account. (ID10) The possibility of working less hours per day was also mentioned, although in some wards you either have to work 100% or not at all. Another possibility was taking more breaks, which was mentioned by a participant who had experienced health problems during her pregnancy, although she also stated that this felt awkward and that she could not predict how long her breaks needed to be as this differed per moment. 33

35 CHAPTER 2 Many participants indicated that when experiencing health problems they asked for help, mostly from their supervisor. Nevertheless, the dependent position as a student was reported once more as an impeding factor to ask for help. Participants stated that is important to know and indicate your own limits and boundaries. It might be helpful if certain agreements, such as less working hours, are made official by the supervisor through an announcement to the team, to increase understanding from colleagues. Further occupational health support needs Need for proper support as a novice nurse It was stated that during education, students should be prepared for their clinical placements. Also, an introduction day for new employees and evaluating this a few months later was mentioned as beneficiary. A guided tour of the hospital and certain important departments should be part of this introduction. In addition, being an extra employee in for example the first two months which enables new employees to watch and run along with colleagues and settle into the workplace is important. It was indicated that the health check at the start of their placement or career would be a good opportunity for the occupational health services to give novice nurses advice about their own health, how to stay healthy and where to ask for help if needed, and to check if they would like to talk about any health problems. Students should also be encouraged to think about how they can protect themselves from developing work-related health problems and what their way of coping is and should be. In addition, a meeting of the new employee with the supervisor after two weeks should be incorporated, in which the new employee can indicate what he or she needs and how he or she can be supported by the team or the hospital. Furthermore, it was mentioned that fixed moments for evaluation should be planned, starting from one month after starting the work, to talk about things such as how do you find your new job and what problems have you encountered. In addition, new employees should have a mentor, for instance a senior nurse who is not their supervisor, whom the new employee can turn to with any problems that they encounter: The funny thing is, when interns from for instance psychology or medicine come here, they are taken under someone s wing. A whole system has been thought out for them. They get a mentor and it is thought out who they can watch and run along with. But when you start working here as a nurse, you basically start working right away. You are supervised, but that purely regards the content of the work. So it would be good if someone is appointed for nurses as well, to whom you can turn, maybe for the first year or so, to ask how things are done here or how do you deal with that, or Not only regarding content of the work, but also, well, a sort of mentor. (ID13) 34

36 Novice nurses needs for occupational health support It was also mentioned that sometimes colleagues are not sufficiently attentive that nursing students might not have experienced certain emotionally demanding events, e.g. a patient dying. More attention should be given by their supervisor, asking them whether they have experienced this before and how they feel about it. The same holds for experiencing new things : it should not be expected that students can cope with these aspects of the job immediately. It was regarded beneficiary if students are given the opportunity to build up their tolerance at their own pace: For instance, I now work in a ward with a lot of wounds, and they did that well: they stressed that they understood that you cannot cope with it very well right away, and that if you didn t feel comfortable you could walk away from it, or at least notify colleagues in advance that you have never seen it before and that it might happen that you don t feel comfortable and walk away from it. Just that you have the possibility to indicate how you feel and that it is not weird that you have not seen many open wounds and seen a lot of blood or experienced that smell, to put it that way. That you know you can take your distance for a minute and that you are allowed to build up your tolerance. ( ) I noticed that I thought it was nice to know [that you were given that possibility], because I thought, it s really weird if I suddenly walk away ( ). That s another one of those intern things, you feel that you have to be able to cope with everything, because after all, you chose to go into nursing so you have to be able to see everything. (ID9) 2 It was also felt that new employees should receive a group training in how to cope with the work and how to detect early signs of mental health problems and that they should be encouraged to ask for help early to prevent development of mental health problems. Need for knowledge The need for knowledge incorporated a need for information and education regarding dealing with needle stick injuries; dealing with and risks of infectious diseases; existing preventive measures and health promotion; coping with rotating shifts; proper footwear; how to cope with physical job demands; and where to ask for help when needed. Additionally, some participants reported a need for tailored advice on work posture and lifting patients. Several of these topics are elaborated on below. Participants reported not knowing what to do or where to go when sustaining a needle stick injury. Also, participants reported wanting to know after sustaining a needle stick injury when they would hear what the results of their blood sample was, how likely it was that they had contracted something, and what signs they should be attentive of after the incident. Regarding infectious diseases, some participants reported that regulations on dealing with these diseases are unclear and sometimes differ per professional whom is asked for 35

37 CHAPTER 2 advice. Another reported that colleagues had little knowledge on how to use isolation materials correctly. One participant reported wanting to know what the risks of working with a patient with an infectious disease were for herself. Also, participants wanted more general information on reasons for patients needing to go into isolation, what you should pay attention to, and why you should use which isolation materials. Participants also stated that they would like information about the effect that working rotating shifts can have on your body, as well as tips about how to deal with rotating shifts: From one of the professional associations for nurses I got advice for during your night shift, what to eat and what not to eat. And I notice that such tips really do me good. ( ) I experience that as positive, and I immediately put them into practice, such as I shouldn t take protein because it makes you really tired and I shouldn t drink milk because it makes you really tired and sluggish, but I should eat fruit and light things because you can tolerate those well. Such tips. (ID12) Another topic that participants reported wanting more information about, was how to cope with physical job demands. How can musculoskeletal problems be prevented; what is the best work posture for which task; what equipment can be used and where can you find this equipment? Several participants also reported a need for tailored advice on how to lift a patient. They stated that they would want a professional to observe them while lifting or shifting a patient and then be given personal advice on how their posture could be improved to prevent musculoskeletal problems. Need for psychosocial support Novice nurses need for psychosocial support included counselling; feeling free to ask for help; discussing unacceptable behaviour of for instance patients; a periodical discussion about how things are going; paying attention to the team atmosphere; taking into account personal work schedule preferences; and finding a job that fits your preferences. Some of these topics are further illustrated below. The need for counselling regarded a form of periodic peer counselling either with fellow students or with colleagues, in which participants can discuss any problems they had encountered. Safety within the team is considered important for this. Individual counselling was also mentioned by some participants as something they would like to see being set up. Sometimes it would be appreciated if the supervisor actively offers counselling or support, because it can be hard to ask for it if the employee has made a mistake. Someone also mentioned that one colleague could have the specific function to offer counselling after experiencing emotionally demanding events. For students, offering the possibly to talk to a psychologist or social worker could be a good solution, or matching a student with a colleague in the clinical placement to talk to when needed. 36

38 Novice nurses needs for occupational health support Also, participants felt that it should be made easier to ask for help. Employers could play a part in this: I think it would be good to get a bit more information about [the link between your work and your health], as an employee. And that it s not strange if you mention it sometimes, because now it s usually perceived as complaining, or, well, uncomfortable, you feel a bit uncomfortable if you say something about it. While I think it s good to, well, to break through that a little, to make it possible to just talk about it. ( ) And that you get the idea that it s better understood, or that it s not strange if you experience [problems]. (ID5) Additionally, the occupational health services could be more open for employees to ask for help anonymously, for instance through an open consultation hour: It might be a good idea for the occupational health services to provide some kind of open consultation hours, or just times that you can walk in with things and say, well, I don t feel well and I want to talk about it. I don t think we have that now. Not that I know of anyway. (ID5) For students, asking for help can be difficult because of their dependent position. Colleagues can help lower the barrier: That they tell you, you can make mistakes here, it s for your own safety to just tell us everything that troubles you, and don t try to solve it yourself but just realise that you are a student, ( ), and that you feel safe in the team. That people can really help you and that you, well, need to be open because it s better for everyone s safety. (ID2) 2 Throughout the study, participants made it clear that team atmosphere is very important for employees health and well-functioning. Some participants further described that they felt more attention should be paid to the team atmosphere and tackling on-the-job gossiping, for instance through team building activities. Some participants stated that they would like their employer to take into account their personal situation and personal needs regarding their work schedule: That you are a bit more flexible and when at a certain moment you say, I can t handle the late shifts or the night shifts so well anymore or, I prefer day shifts, that that s possible. You know, even just the rule that you have to solve it yourself, but that that is allowed. [Swapping shifts with a colleague] is allowed, but only to a certain extent, and it s so limited that there are very little opportunities to swap shifts. (ID11) They mentioned that schedules that fit their preferences would prevent impaired health to some extent and would improve their well-being. Participants also reported how important it is to find a job that matches you personally. During their studies, students could be encouraged to reflect on what suits their preferences, using a form of career counselling. 37

39 CHAPTER 2 Need for physical support The need for physical support was diverse and incorporated proper equipment and safety measures; support to keep a healthy lifestyle; and on-the-job massages. Regarding proper equipment and safety measures, it was mentioned that they would like their organisation to reimburse proper shoes and to offer appropriate equipment for lifting and shifting patients. Regarding support to keep a healthy lifestyle, participants stated that they would like their employers to offer a discount on gym membership and to pay attention to healthy foods, for instance by offering free fruit during lunch hours. Another participant stated that her work is so tightly scheduled that she does not have time to eat, let alone eat healthy. Ideas for implementation of occupational health support Regarding occupational health support needs, participants provided various ideas on how this support might be given to them. Information about possible effects on nurses own health should be integrated in their education. For instance, when learning about handling needles during nursing education, the implications of sustaining a needle stick injury could also be discussed. At the beginning of the placement or career, general information about the most frequently encountered work-related health topics at that specific workplace and the occupational health and safety rules could also be given. Regarding dissemination of information on occupational health topics, participants reported several methods that they considered useful. Information could for example be given in class during nursing education; in clinical lessons at work; through watching and learning from colleagues in the beginning of their placement or career; and by encouraging novice nurses to read the protocol. They also mentioned the possibility of information leaflets or posters at appropriate places and paying organisational attention to the subject, for instance by organising a special week about an important topic. In addition, conferences for nurses and the professional association could provide information on occupational health topics. Mostly, participants stated that repeating information once in a while would be beneficiary. This was especially the case for information about dealing with physical job demands. The key elements of experienced and required occupational health support are provided in Box 2, giving an overview of the elements that occupational health support for novice nurses should encompass. The elements have been categorised into support that should be given during nursing education; support that should be given at the start of the clinical placement or new job; and support that should be given a more general place at the workplace. 38

40 Novice nurses needs for occupational health support Box 2 Key elements of novice nurses occupational health support needs. During nursing education Knowledge Education on occupational health topics: dealing with needle stick injuries; dealing with infectious diseases; possible preventive measures and health promotion; coping with rotating shifts; proper footwear; how to cope with physical job demands and where to ask for help when needed Psychosocial support Preparation of students for clinical placements Career counseling Appropriate support from nurse educators Peer support from fellow students 2 At the start of the clinical placement or new job Knowledge Introduction day including a tour of the hospital Information from occupational health services at the start of their placement/career Being an extra in the first months Psychosocial support Discussion between new employee and supervisor about personal support needs Reflection on coping strategy and how to protect themselves from developing work-related health problems Mentor whom the new employee can turn to with any questions or problems Proper support during or after emotionally demanding events, opportunity to build up tolerance at one s own pace Group training in how to cope with the work and how to detect early signs of mental health problems, including encouragement to ask for help early At work in general Knowledge Education at work on occupational health topics: dealing with needle stick injuries; dealing with infectious diseases; possible preventive measures and health promotion; coping with rotating shifts; proper footwear; how to cope with physical job demands and where to ask for help when needed Tailored advice on work posture and lifting patients Occupational health advice from professionals 39

41 CHAPTER 2 Box 2 Continued. Psychosocial support Peer support from colleagues Attention for team atmosphere Counselling, individual or through periodic peer counselling either with fellow students or with colleagues Being able and feeling free to ask colleagues or supervisor for help Possibility to ask occupational health services for help anonymously Fixed evaluation moments Knowing and being able to indicate one s own limits and boundaries Personal situation and personal needs regarding work schedule taken into account Physical support Measures/protocols to deal with incidents; discussing unacceptable behaviour Preventive measures Possibilities to distribute workload between colleagues Possibilities to performing different or adapted tasks or working less hours per day when suffering from health problems Support to keep a healthy lifestyle On-the-job massages DISCUSSION The aim of this study was to identify novice nurses experiences with the link between their work and their health; support that they experience to cope with this link; and their further support needs to prevent them from developing work-related health problems and to help them to function optimally in spite of health problems. Our findings indicated that novice nurses already experience work-related health problems early in their career. Reported causes were physical work demands, disagreeable contact with others, having to do a lot of work in a limited time, accidents with biological material and otherwise being exposed to infectious diseases, working shifts, and making mistakes; causing health problems such as musculoskeletal problems, stress and worrying, anxiety, fatigue, sleeping problems, and infectious diseases. Participants also described experiences with how health problems lead to suboptimal work functioning. Received occupational health support and further needs for occupational health support should be given during nursing education, at the start of their clinical placement or new job, and at work in general. Occupational health support needs during education covered knowledge (e.g. paying attention in class to dealing with shift work) and psychosocial support (e.g. career counselling). At the start of their clinical placement or new job, novice nurses should also be offered knowledge (e.g. information from occupational health services) and 40

42 Novice nurses needs for occupational health support psychosocial support (e.g. having a mentor). In addition, at work in general, knowledge (e.g. tailored advice on proper lifting position), psychosocial support (e.g. a positive team atmosphere) and physical support (e.g. suitable preventive measures) should be given. Interpretation of findings The transition from being a nursing student to being a qualified nurse has received much attention in scientific literature. 23,24 However, literature on occupational health support to prevent novice nurses from developing work-related health problems and to help them function optimally in spite of any health problems was lacking. This study has provided knowledge on the novice nurses needs regarding occupational health support. We found that occupational health support should not only be given while on clinical placement or at work, but also during nursing education. The British Royal College of Psychiatrists 20 also reflects that healthcare students help-seeking might be impeded due to fear of being suspended or excluded from the course. An interesting programme in this respect was described by Yearwood and Riley, 25 in which attention was paid to the nursing students own health and wellbeing. It was experienced that this programme helped nursing students to discuss their problems and difficulties with their peers and to seek help. In addition, students realised they needed to take care of themselves to be able to take care of their patients. 2 Furthermore, a place for occupational health support is required at the workplace. Our findings indicated that some aspects of occupational health support require extra attention at the start of a clinical placement or the new job. For example, a simple introduction to the workplace but also receiving information from the occupational health services. Psychosocial support at the start was also considered favourable, for instance by being paired to a mentor. Other studies underline the benefits of such support. 23 In addition, our participants reported difficulties with juggling school assignments, working in clinical placements and other responsibilities. These difficulties have also been reported by other studies on nursing students. 8 Tutoring or mentoring programmes might help to cope with these difficulties. Nevertheless, a large part of occupational health support for nurses needs to be more grounded in the workplace and should not only been given at the start of working in nursing. Implementing workers health surveillance might be a useful strategy to detect any problems in health or work functioning and to timely offer help when needed. 26 One important element of more general occupational health support addressed by our participants is a culture of support among team members, helping each other and treating each other with respect. The importance of a culture of support among team members is reflected by other studies, finding that a positive atmosphere leads to positive 41

43 CHAPTER 2 effects on nurses quality of life, 27 nurses wellbeing, 28 and proactive responding to mental health issues of colleagues. 29 A culture of support also appears to form a buffer for developing mental health problems for healthcare workers, 4,30 and discussing details of medical errors with colleagues was found to be valuable for individual and team recovery. 31 Another important element of occupational health support that our participants reported, was acquiring knowledge on certain topics intrinsic to the job of nursing. According to the Dutch Working Conditions Act, the employer should give the employee sufficient and adequate instructions and training about, amongst others, the risks within the organisation and how to deal with these risks in a safe and healthy way. 21 However, our participating novice nurses for instance reported that although certain safety equipment is available in the workplace, many nurses do not know how to use this equipment properly. A need for knowledge on dealing with physical job demands was also reported by our participants. The time spent on education in ergonomics in the Dutch educational institutions offering healthcare studies is limited when considering the amount of physical work that nurses perform. 32 Moreover, some of the institutions use outdated teaching materials and knowledge. 32 In the workplace, the inadequate knowledge and use of equipment that has been developed to deal with the physical as well as the mental job demands of healthcare workers is also recognised Training and education combined with an ergonomic intervention (i.e. the use of additional mechanical or other aid equipment) have been found effective to decrease musculoskeletal symptoms in nurses, 36 underlining the importance of more and appropriate education regarding these aspects. Although the occupational health support needs that the mental healthcare nurses participating in our study reported overlapped with those reported by the general healthcare nurses, this was mainly on psychosocial level. Working in mental healthcare generally poses less physical strain for nurses. This was reflected in our findings that participating mental healthcare nurses had no experience with physical health problems due to their work and also did not report occupational health support needs regarding physical job demands. Therefore, occupational health support should not be implemented using a standard approach, but the nursing specialisation should be taken into account. Strengths and limitations To explore the needs of novice nurses regarding occupational health support, we chose a qualitative research methodology. Consequently, the topic could be inductively explored from the perspective of the novice nurses themselves. Furthermore, we chose to conduct individual interviews, to thereby enable going into the personal situation in detail. This proved a valuable approach, since the participating novice nurses had quite different stories and not all were as familiar with the topic of occupational health. In addition, 42

44 Novice nurses needs for occupational health support conducting individual interviews prevented participants from experiencing peer pressure and therefore not reporting all experiences and needs, as some aspects of the interview might have been experienced as sensitive. 37 We conducted interviews with both nursing students with clinical placement experience as well as newly qualified nurses who have already gone through the transition from student to qualified nurse. Incorporating these different perspectives formed an important strength of our study, as it has extended our knowledge on novice nurses needs along the spectrum from being a nursing student to having started working as a qualified nurse recently. 2 Implications for practice Our findings indicated that nursing students experience work-related health problems and suboptimal work functioning due to health problems early in their career and while still in training to be a nurse. This underlines the importance of paying attention to occupational health support early, to prevent novice nurses from developing work-related health problems and to help them function optimally in spite of health problems. Our study further indicated several elements that should be incorporated in sufficient occupational health support for novice nurses. Nurse educators, employers who offer clinical placements for nursing students and who employ nurses, as well as occupational health services for healthcare employees each bear part of the responsibility to address these elements. Therefore, these parties are recommended to consider to what extent they currently meet novice nurses needs regarding occupational health support and how they could improve their occupational health support for this occupational group. 43

45 CHAPTER 2 REFERENCES 1 Sluiter JK, de Croon EM, Meijman TF, Frings-Dresen MH. Need for recovery from work related fatigue and its role in the development and prediction of subjective health complaints. Occup Environ Med 2003; 60 Suppl 1:i62-i70. 2 d Errico A, Viotti S, Baratti A et al. Low Back Pain and Associated Presenteeism Among Hospital Nursing Staff. J Occup Health 2013; 55: Cherry N, Meyer JD, Adisesh A et al. Surveillance of occupational skin disease: EPIDERM and OPRA. Br J Dermatol 2000; 142: Gao YQ, Pan BC, Sun W et al. Anxiety symptoms among Chinese nurses and the associated factors: a cross sectional study. BMC Psychiatry 2012; 12: Evans K. Expectations of newly qualified nurses. Nurs Stand 2001; 15: Laberge M & Ledoux E. Occupational health and safety issues affecting young workers: a literature review. Work 2011; 39: Schulte PA, Stephenson CM, Okun AH et al. Integrating occupational safety and health information into vocational and technical education and other workforce preparation programs. Am J Public Health 2005; 95: Last L & Fulbrook P. Why do student nurses leave? Suggestions from a Delphi study. Nurse Educ Today 2003; 23: Whitehead B & Holmes D. Are newly qualified nurses prepared for practice? Nurs Times 2011; 107: Smith DR & Leggat PA. Musculoskeletal disorders among rural Australian nursing students. Aust J Rural Health 2004; 12: Cheung K. The incidence of low back problems among nursing students in Hong Kong. J Clin Nurs 2010; 19: Rudman A & Gustavsson JP. Early-career burnout among new graduate nurses: a prospective observational study of intra-individual change trajectories. Int J Nurs Stud 2011; 48: Rudman A & Gustavsson JP. Burnout during nursing education predicts lower occupational preparedness and future clinical performance: a longitudinal study. Int J Nurs Stud 2012; 49: Hasson D, Lindfors P, Gustavsson P. Trends in self-rated health among nurses: a 4-year longitudinal study on the transition from nursing education to working life. J Prof Nurs 2010; 26: Small L, Pretorius L, Walters A, Ackerman MJ. A surveillance of needle-stick injuries amongst student nurses at the University of Namibia. Health SA Gesondheid 2011; 16:Art. # Petrucci C, Alvaro R, Cicolini G et al. Percutaneous and mucocutaneous exposures in nursing students: an Italian observational study. J Nurs Scholarsh 2009; 41: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: Letvak SA, Ruhm CJ, Gupta SN. Nurses presenteeism and its effects on self-reported quality of care and costs. Am J Nurs 2012; 112: Letvak S, Ruhm C, Lane S. The impact of nurses health on productivity and quality of care. J Nurs Adm 2011; 41: Royal College of Psychiatrists. Mental health of students in higher education. London: Royal College of Psychiatrists, Report no.: CR European Agency for Safety and Health at Work. English translation of the Dutch Working Conditions Act (2007), Accessed June Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ 2000; 320: Jewell A. Supporting the novice nurse to fly: a literature review. Nurse Educ Pract 2013; 13: Phillips C, Kenny A, Esterman A, Smith C. A secondary data analysis examining the needs of graduate nurses in their transition to a new role. Nurse Educ Pract 2014; 14:

46 Novice nurses needs for occupational health support 25 Yearwood E & Riley JB. Curriculum infusion to promote nursing student well-being. J Adv Nurs 2010; 66: Gärtner FR, Nieuwenhuijsen K, Ketelaar SM et al. The Mental Work Study: Effectiveness of a Mental Module for Workers Health Surveillance for Nurses and Allied Health Care Professionals on Their Help-Seeking Behavior. J Occup Environ Med 2013; 55: Bourbonnais R, Vézina M, Durand PJ et al. Evaluative research intervention to optimize the psychosocial and organizational work environment for caregiving staff. Ottawa, Ontario: Canadian Health Services Research Foundation, Utriainen K, Ala-Mursula L, Kyngas H. Hospital nurses wellbeing at work: a theoretical model. J Nurs Manag 2014; DOI /jonm [Epub ahead of print]. 29 Moll SE. The web of silence: a qualitative case study of early intervention and support for healthcare workers with mental ill-health. BMC Public Health 2014; 14: de Jonge J, Le Blanc PM, Peeters MC, Noordam H. Emotional job demands and the role of matching job resources: a cross-sectional survey study among health care workers. Int J Nurs Stud 2008; 45: Sirriyeh R, Lawton R, Gardner P, Armitage G. Coping with medical error: a systematic review of papers to assess the effects of involvement in medical errors on healthcare professionals psychological well-being. Qual Saf Health Care 2010; 19:e de Vries EM, Knibbe NE, Knibbe JJ. Ergonomics in healthcare education [in Dutch: Ergonomie in de zorgopleiding]. Zoetermeer, the Netherlands: Stichting RegioPlus, Dekker H, Tap R, Mevissen J. Final evaluation of the Arboplusconvenant of Academic Hospitals [in Dutch: Eindevaluatie Arboplusconvenant Universitaire Medische Centra en Academische Ziekenhuizen]. Amsterdam, the Netherlands: Regioplan Beleidsonderzoek, Report no.: Douwes M, van den Heuvel S, Sonneveld H. The great danger of healthcare. Review of the work-related risks of and measures for nurses and carers [in Dutch: Het grote gevaar van de zorg. Overzicht van arbeidsrisico s van en maatregelen voor verpleegkundigen en verzorgenden]. Hoofddorp, the Netherlands: TNO, Report no.: R Koppelaar E, Knibbe JJ, Miedema HS, Burdorf A. Determinants of implementation of primary preventive interventions on patient handling in healthcare: a systematic review. Occup Environ Med 2009; 66: Bos EH, Krol B, van der Star A, Groothoff JW. The effects of occupational interventions on reduction of musculoskeletal symptoms in the nursing profession. Ergonomics 2006; 49: Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007; 19:

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48 3 THE MENTAL WORK STUDY: DESIGN OF A RANDOMIZED CONTROLLED TRIAL ON THE EFFECT OF A WORKERS HEALTH SURVEILLANCE MENTAL MODULE FOR NURSES AND ALLIED HEALTH PROFESSIONALS Fania R. Gärtner Sarah M. Ketelaar Odile Smeets Linda Bolier Eva Fischer Frank J.H. van Dijk Karen Nieuwenhuijsen Judith K. Sluiter BMC Public Health 2011; 11:290.

49 CHAPTER 3 ABSTRACT Background: Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. Methods: The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1,731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual s mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. Discussion: When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees mental health and work functioning. Trial Registration: NTR

50 Study design for evaluation of a mental health module for WHS BACKGROUND Common mental disorders (CMDs) can have negative effects on work as they can impair work functioning and increase sickness absence. 1-5 In some occupations, the impairments in work functioning can have serious consequences, such as injuries to workers. One occupation in which this vulnerability is highly present is nursing. Nurses, the largest occupational group in healthcare, are at higher risk of developing mental health problems compared to workers outside of the health care sector and compared to other (health) service workers. 6 The relative risk for depression is high for nurses, RR = 3.5, 95% CI (1.3, 9.6), compared to other human service workers and other healthcare workers. 6 This high risk might partly be explained by the very nature of the work, with work environment characteristics that are known to promote the occurrence of mental health complaints, such as high job demands, low job control and low social support. 7,8 Furthermore, in the health care sector, impairments in work functioning can have serious effects not only for the nurses but also for patients and their safety as a recent literature review showed. 8,9 3 In the Netherlands, the occupational health care that is provided for employees with mental health problems can be considered effective. Care according to the guidelines for occupational physicians (OP) treatment of workers with mental health problems has been proven to improve mental health and to enhance return to work for sick-listed employees. 10,11 However, the health service for OPs is often not used by workers until they are sick-listed. Late or no help-seeking for mental health complaints is a well-known problem inside and outside of the occupational health service. 12,13 Preventive actions are needed to provide timely help before work functioning is reduced to the extent that workers cause serious incidents or must call in sick. Early identification of health complaints and risks in work functioning to provide timely help is a first step in the prevention of more serious consequences for the health and safety of the nurses and their patients. Furthermore, preventive actions can improve the wellbeing of employees in the health care sector. Wellbeing can have positive effects on the engagement and productivity of employees. With the age of the caring workforce increasing, the importance of sustainable labor participation by senior employees is increasing. Therefore, it is of utmost importance to keep the caring work force engaged and mentally fit so they can continue to meet the high mental demands of modern-day work. A Workers Health Surveillance (WHS) mental module may be a successful preventive strategy for CMDs and impairments in work functioning in the health care sector. Within the occupational health care setting, WHS is a well-developed strategy for preventive actions. 14,15 WHS aims to detect negative health effects of work in an early stage to enable timely interventions. 15 Although the use and application of WHS is rising for various occupations and health effects, little is known about WHS targeting mental health effects. 49

51 CHAPTER 3 In a recent literature review by Plat et al. 16 on WHS in military and emergency service personnel, three studies included psychological health aspects, one in police personnel, 17 one in rescue and recovery workers 18 and one in soldiers. 19 WHS for mental health effects in nurses has not yet been scientifically evaluated. Therefore, the aim of this study is to test the effectiveness of a job-specific WHS mental module for nurses and allied health professionals. Although the International Labour Organization has formulated recommendations for the use of WHS, the design differs between countries. In the Netherlands, a policy guideline on how to conduct WHS exists. 20 This guideline does not prescribe any specific interventions, but includes principles and leading criteria such as the statement that screening for health problems should only be conducted if effective interventions for that health problem are available. Furthermore, one of the core aims of the guideline is the monitoring and improvement of both the health and functioning of workers. Therefore, our job-specific WHS mental module includes screening for early signals of mental health complaints and for impairments in work functioning. For the detection of impaired mental health, several validated instruments exist that are suited for the working population. However, until recently, no instrument for detecting impaired work functioning in healthcare workers related to mental health problems was available. Such an instrument has now been developed to be used in the hospital environment, the Nurses Work Functioning Questionnaire (NWFQ). 21 The NWFQ was designed based on literature studies and focus group investigations with the workers supervisors, human resource managers and occupational health professionals. The NWFQ has a high content validity, and its seven subscales show good or acceptable internal consistency. For the interventions that follow the screening, two different strategies were developed. The first strategy is a consultation offered by the OP following a protocol for care for workers with mental health complaints, as developed for this study. The second strategy is a choice of self-help e-mental health interventions that is offered to all workers those with and without complaints. The choice is tailored to the individual screening results. The objective of the Mental Work study is to study the effectiveness of two strategies for the WHS mental module in one cluster randomized controlled trial design with three arms. Substudy 1 aims to test the effectiveness of screening for problems in mental health and work functioning plus advice on appropriate interventions by an OP compared to a control group. It will study the effects on adequate help-seeking behavior, work functioning and mental health. We hypothesize that employees who receive the WHS mental module with screening plus an invitation for OP-care will show more adequate help-seeking behavior than employees in the control group. Furthermore, we hypothesize that work functioning and mental health problems will improve in employees 50

52 Study design for evaluation of a mental health module for WHS who receive the WHS mental module with screening plus invitation for OP-care compared to employees in the control group. Substudy 2 aims to compare the OP-care strategy with a second strategy, including the same screening of problems in mental health and work functioning as in the OP-care strategy plus a stepped care e-mental health approach. Substudy 2 will compare the effects of both strategies on work functioning and mental health. We hypothesize that both WHS mental module strategies are equivalent in their effectiveness on work functioning, mental health and wellbeing compared to the control group. An economic evaluation of the WHS mental module will be conducted alongside the randomized controlled trial. Cost-effectiveness of the WHS mental module will be assessed from a societal perspective. The employer s perspective will be considered in a cost-benefit analysis. Regarding cost effectiveness, we hypothesize that the WHS mental module with E-mental health interventions is more cost effective than the WHS mental module with OP-care. 3 METHODS/DESIGN In the following description of the design of the Mental Work study we follow the CONSORT statement, which aims to improve the quality of reporting randomized controlled trials (RCT). 22,23 Study design A cluster randomized controlled trial with three parallel arms will be performed in order to evaluate the effectiveness of two strategies for a WHS mental module for nurses and allied health professionals: the OP-care strategy and the E-mental health strategy. The study combines two separately funded substudies. Substudy 1 will compare the control arm with the OP-care arm a screening on mental health complaints and impaired work functioning followed by a consultation with an OP and appropriate interventions if necessary. Substudy 1 will test the effect on help-seeking behavior, work functioning and mental health of employees with problems in mental health and/or work functioning. Substudy 2 will compare the E-mental health arm a screening on mental health complaints and impaired work functioning followed by a tailored choice of self-help e-mental health interventions with the control arm and with the OP-care arm. Additionally, a subgroup analysis of the healthy participants comparing the E-mental health arm with the OP-care arm will be conducted. Substudy 2 will test the effect of the interventions on work functioning and mental health. 51

53 CHAPTER 3 Participants will be followed for six months. Two follow-up measures will be conducted, one at three months and one at six months. The Medical Ethics Committee of the Academic Medical Center in Amsterdam (AMC) gave approval for the study. Figure 1 presents an overview of the study design. Below, differences between Substudy 1 and Substudy 2 are described. Otherwise, the information is equal for both parts. Randomization of departments to study arm 1, 2 or 3 (departments: N = 86; employees: N = 1,731) Study arm 1: control group (N = 561) Study arm 2: OP-care group (N = 591) Study arm 3: e-mental health group (N = 579) Informed Consent + Baseline questionnaire (T0) Participants receive screening results on mental health and work functioning Participants receive screening results on mental health and work functioning Participants with mental health complaints or impaired work functioning: invitation for OP-consultation All participants: tailored choice of self-help e-mental health interventions Follow-up questionnaire (T1) at 3 months Follow-up questionnaire (T2) at 6 months Participants receive screening results on mental health and work functioning All participants: tailored choice of self-help e-mental health interventions Figure 1 Study design. 52

54 Study design for evaluation of a mental health module for WHS Setting The study will be performed in one Dutch academic medical center, a hospital with 7,000 employees and 1,102 beds. The organization has its own in-company occupational health service. Each of the different divisions in the medical center has one OP assigned for its occupational health care. In the Dutch occupational health care system, OPs fulfill preventive tasks, have the duty of detecting occupational diseases and provide (return-towork) counseling for sick-listed employees. In the Netherlands, if they are reported sick, workers are required to visit their OP for independent judgment of sick leave and for return-to-work guidance. Furthermore, all workers can make use of the free accessible consulting hour for employees with questions about work and health. 24 According to the in-company occupational health service, usage of the free accessible consultations by employees is limited. Study population The research population includes all nurses, including surgical nurses and anesthetic nurses, and allied health professionals working at one Dutch academic medical center. In total, 1,731 nurses and allied health professionals work in the medical center in 86 different wards, including outpatient wards. Employees who are sick-listed at the start of the study and expected to be on sick leave for more than two weeks are excluded from the study, as they will in any case consult an OP. 3 Recruitment of participants For a successful intervention study in a work setting, all layers of the organization must fully support the study. As we received endorsement from the board of directors, the nurse directors and the workers counsel to perform the study, the likelihood for the departments to accept participation is high and all departments are expected to participate. During the enrollment period, information will be given on the hospital intranet, posters will be put up in the hospital building and flyers will be given out to promote the study. Prior to the recruitment of individual employees, all wards will be informed about the Mental Work study by personal letters to the nurse directors and head nurses and the managers of allied health professionals. Subsequently, the individual workers will be informed by a letter to their home address with detailed information about the study procedure and about the safety and privacy of the individuals. Ten days later, an will be sent to the employees work- account, encompassing study information, a link to the online questionnaire and a personal log-in name and password. Agreeing with the informed consent, which is shown online prior to the questionnaire, is a prerequisite for starting the questionnaire. It will be possible for participants to log in on the website at any time and from any computer. It is also possible to log out at any point during the 53

55 CHAPTER 3 survey and to continue after logging in again. In the four weeks after the invitation for the study, three reminders will be sent to employees who have not yet started or completed the questionnaire. Interventions OP-care The first WHS mental module strategy encompasses an online screening for mental health complaints and work functioning problems plus an optional consultation with an OP for employees with mental health problems and/or work functioning problems. Directly after filling out the screening questionnaire, participants will automatically receive digital feedback on the screening results. Participants who score above a cut-off point for either the mental health complaints, work functioning impairments or both will receive an invitation from the in-company occupational health service for a face-to-face consultation with their OP scheduled within two weeks after filling out the screening questionnaire at baseline. The consultation is voluntary and supervisors of employees will not be informed about the invitation or the content of the consultation with the OP. In order to structure the consultation of the OP, a seven-step protocol will be applied. The seven steps are: 1) discussing expectations; 2) discussing screening results and characteristics of mental health/work functioning complaints; 3) discussing possible causes in the private, work and medical situation and consequences for performing the work; 4) giving a diagnosis and offering a rationale; 5) giving advice for reduction of health complaints and for the improvement of work functioning and the prevention of incidents at work and discussing communication with the supervisor; 6) discussing a possible follow-up trajectory or referral to other care givers; and 7) summarizing the consultation. This protocol closely follows the care as usual of the OPs. It was developed by means of interviews with the five participating OPs and based on the evidence-based guideline for OP s treatment of workers with mental health problems, which was developed by the Dutch Society of Occupational Medicine. 11,25 The main difference with the care as usual is the focus on identifying impairments in work functioning and giving advice on the improvement of work functioning and the prevention of consequences of impaired work functioning. All participating OPs were trained in using the protocol for the consultations. E-mental health The second WHS mental module strategy encompasses an online screening for mental health complaints and work functioning problems plus tailored advice on self-help e-mental health interventions. In this strategy, after filling out the screening questionnaire, feedback on results will be provided digitally. Workers with impaired work functioning will be digitally offered advice on how to improve their work functioning. Furthermore, an 54

56 Study design for evaluation of a mental health module for WHS electronic health intervention trajectory will be offered to each participant to improve mental health and wellbeing. The trajectories offered for improvement of mental health will be tailored to the needs of the worker as assessed by the screening. The e-mental health interventions that can be offered are: Psyfit: aimed at the promotion of wellbeing. It is suitable for everyone, including healthy participants. 26 The effectiveness of Psyfit is currently being examined. 27 Strong at work (Sterk op je werk): aimed at gaining insight into work stress and at learning skills to cope with work stress. Colour your life (Kleur je leven): aimed at tackling depressive symptoms. Research has shown Colour your life to be (cost) effective Don t Panic Online (Geen Paniek Online): aimed at reducing panic symptoms for sub-clinical and mild cases of Panic Disorder. This intervention is based on Don t Panic (Geen Paniek), a face-to-face group course for sub-clinical and mild panic symptoms. Don t Panic has proven to be cost-effective The effectiveness of this online intervention is currently being studied. 38 Drinking less (Minder drinken): aimed at reducing risky alcohol drinking behavior and shown to be effective. 39,40 3 The e-mental health interventions are self-help programs on the internet aimed at reducing specific mental health complaints or enhancing wellbeing. The programs are mainly based on cognitive behavioral therapy principles and combine a variety of aspects, for instance, advice, weekly assignments, the option of keeping a diary and a forum to get in contact with others who have similar complaints. The self-help e-mental health interventions were developed by the Trimbos-institute. E-mental health programs have been shown to be effective at improving impaired mental health 30,31,39-41 and at enhancing wellbeing. 42,43 Control group In the control arm, participants will fill out the baseline questionnaire; however, results of the screening-questionnaires will not be reported back to participants, and no further interventions will be advised at baseline. As compensation, participants in the control arm will receive their personal screening results together with a tailored choice for a self-help e-mental health intervention six months after baseline, which is identical to the intervention in the E-mental health arm at baseline. For ethical reasons, a suicide-risk protocol is implemented in all study arms. Participants identified as being at high risk of suicide will receive immediate feedback on their self-reported suicide risk. They will be advised to seek help instantly, and they are asked to choose between either contacting their general practitioner or receiving an invitation for an urgent consultation with their OP. 55

57 CHAPTER 3 Co-interventions To our knowledge, no co-interventions on the organization or ward level aimed at mental health or work functioning improvement will be taking place in the medical center at the time of this study. Measures Screening instruments used at baseline Impaired work functioning Impaired work functioning will be measured using the job-specific Nurses Work Functioning Questionnaire (NWFQ). 21 The NWFQ aims to measure impaired work functioning due to CMDs in nurses and allied health professionals. This 50-item self-report questionnaire consists of seven subscales: 1) cognitive aspects of task execution and general incidents; 2) impaired decision making; 3) causing incidents at work (not applicable for allied health professionals); 4) avoidance behavior; 5) conflicts and annoyances with colleagues; 6) impaired contact with patients and their family; and 7) lack of energy and motivation. Cronbach s alphas vary between 0.70 and Response formats vary between 5-category and 7-category scales; however, the number of categories is the same for all items of one subscale. The content of the response scales varies between Likert-type scales (0 = totally disagree to 6 = totally agree; 0 = disagree to 4 = agree; 0 = no difficulty to 6 = great difficulty), relative frequency categories (0 = almost never to 6 = almost always; 0 = almost never to 4 = almost always), and absolute frequency categories (0 = not once to 6 = in general more than once a day). Sum scores of the subscales range from As yet, no validated cut-off scores exist for this fairly new questionnaire. Based on prior data of the study population, 44 cut-off values were calculated according to the following principle. Sumscores on the different subscales can lead to three categories: green, orange, and red. Therefore, two cut-off values are set, at the 67th percentile and at the 75th percentile of participants with mental health complaints. In two of the 7 subscales (subscale 2 and 4) the cut-off values for orange and red were identical due to little variation; in this case, cut-off values were set at the 75th and 85th percentiles of participants with mental health complaints. For the total NWFQ, a red score on one subscale or three or more orange scores will lead to case identification of impaired work functioning. In the prior dataset, this resulted in 31% of the total sample. Distress Distress will be measured with the distress subscale of the Four-Dimensional Symptoms Questionnaire (4DSQ). 45,46 The 16-item questionnaire uses a 5-point response scale (0 = no, 4 = very often) and has a Cronbach s alpha of For case identification, a cut-off point of 11 will be applied

58 Study design for evaluation of a mental health module for WHS Need for recovery Early symptoms of work-related fatigue will be measured using the Need for recovery subscale of the Dutch Experience and Evaluation of Work (Dutch: VBBA) questionnaire. 48 The 11-item questionnaire with dichotomous response categories (yes, no) has a Cronbach s alpha of A cut-off point of 6 will applied. This gives a sensitivity of 0.72 and a specificity of Alcohol use To measure risky drinking behavior, the 3-item AUDIT-C will be used. The three items ask for frequency of specific drinking behavior, varying in formulations for the items. 53 Two items have a 5-point response scale, and 1 item has a 6-point response scale. The cut-off score is 5 for men with a sensitivity of 90.9 and specificity of 68.4 and 4 for women with a sensitivity of 92.4 and specificity of Depression and Anxiety Depression and anxiety will both be measured with the corresponding subscales of the Brief Symptom Inventory (BSI). 55 Each subscale has six items with a 5-point response scale (0 = not at all, 4 = extremely). Cronbach s alphas are 0.87 for both scales. 55 For both subscales, mean scores of 0.42 are used for case identification, with a sensitivity of 0.86 and a specificity of 0.66 for depression and a sensitivity of 0.83 and a specificity of 0.62 for anxiety. 56 Suicide risk One item of the BSI depression subscale asks for suicidal thoughts. An answer on this item in one of the upper two response categories (rather a lot or extremely) will identify a person as being at high risk for suicide. Panic disorder The panic module of the Patient Health Questionnaire (PHQ-15) will be used for the assessment of panic disorders; however, it will only be used in participants identified as having anxiety complaints. 57 The 15 items have dichotomous answering categories (yes, no) and a Cronbach s alpha of For case identification, we use the following procedure: two answers affirmative on the first four items plus four symptoms affirmative on the following 11 items. This identification procedure has a sensitivity of 0.91 and a specificity of Post traumatic stress disorder Post traumatic stress disorder is measured by the Schok Verwerkings Lijst (SVL), 60 a Dutch translation of the Impact of Event Scale. 61 The 15 items can be answered on a 4-point response scale (0 = not at all, 3 = often). Van der Ploeg et al. 62 found a Cronbach s alpha of 0.94 in a work-related sample. A cut-off point of 26 is applied

59 CHAPTER 3 Work relatedness of mental health complaints Work relatedness of mental health complaints is measured by one item: Do you think that your work has negative consequences for your mental health? This self-formulated item has a dichotomous response scale (yes, no). At T2, the same screeners will be used in the control arm. Primary outcomes measured at baseline, three month follow-up and six month follow-up Substudy 1 The primary study parameter of the comparison between the OP-care arm and the control arm is help-seeking behavior. It regards formal help sources that the subject has used during the past three months. In the operationalization of formal help sources, 11 help sources are presented (i.e. psychologist, psychiatrist, general practitioner, OP, physiotherapist, supervisor, coach, in-company social worker, social worker, religious counselor, alternative therapeutic treatments). The list of help sources is developed in analogy with earlier studies on help-seeking behavior The outcome measure help-seeking behavior is dichotomized into did seek formal help for participants who had made use of any of the 11 caregivers and did not seek formal help if none of the 11 caregivers were visited. Substudy 2 The primary outcome measure of the comparison of the E-mental health arm with the OP-care and the control arm is work functioning, operationalized as job-specific impairments in work functioning. It will be measured using a total score of the Nurses Work Functioning Questionnaire (NWFQ). Secondary outcomes measured at baseline, three month follow-up and six month follow-up Secondary outcomes of both Substudy 1 and Substudy 2 are mental health complaints and absenteeism. The secondary outcomes that are only measured for Substudy 1 are work functioning and additional help-seeking information (intention to seek help, work as content of the consultation, frequency of visits, and informal help-seeking behavior). The secondary outcomes that are only measured for Substudy 2 are work ability, turnover intention, wellbeing, and work productivity. 58

60 Study design for evaluation of a mental health module for WHS Mental health complaints Mental health complaints are operationalized as the six mental health complaints screened or (i.e. distress, need for recovery, alcohol use, depression, anxiety and posttraumatic stress disorder). These are measured as described above. Absenteeism Three items from the Productivity and Disease Questionnaire (PRODISQ) Module C are used to measure absenteeism from work. Absenteeism is operationalized as number of days on sick leave during the last three months and number of periods of sick leave during the last three months. 68 Work functioning Work functioning will be measured by the NWFQ as described above. 3 Additional information on help-seeking behavior Additional information concerning help-seeking behavior will be used as a secondary outcome measure, which includes 1) intention to seek help, assessed for the 11 formal help sources; 2) work as content of the consultation of various caregivers; 3) frequency of visits to the caregivers; and 4) informal help-seeking behavior towards family or friends. Work ability Work ability will be assessed with the first item of the Work Ability Index (WAI). 69 This item concerns the evaluation of current work ability compared to their lifetime best on an 11 point scale (0 = completely unable to work, 10 = work ability at its best). Turnover intention Turnover intention will be assessed by one item on plans to seek for a job outside of the present organization during the next year. The item can be answered on a dichotomous response scale (yes, no). Wellbeing Wellbeing is measured with three questionnaires measuring different concepts. The Mental Health Continuum-Short Form (MHC-SF) is a 14-item self-report questionnaire on wellbeing in the categories languishing, moderate and flourishing. 70 The MHC-SF measures hedonistic wellbeing as well as psychological and social wellbeing. Participants rate the items on a 6-point scale (0 = never, 5 = every day). The MHC-SF has shown good internal consistency (> 0.80) and discriminant validity. 71,72 59

61 CHAPTER 3 The WHO-5 wellbeing scale contains five positively formulated items on mental health. Participants are asked to rate the items using a 6-point scale (0 = never, 5 = all of the time). The WHO-5 has been validated in different populations with an acceptable internal consistency (Cronbach s alpha 0.84). 73 The Utrecht Work Engagement Scale (UWES-9, short-form) measures engagement at the workplace. It is a 9-item scale, and items are scored on a 7-point rating scale (0 = never, 6 = always). Cronbach s alpha of the UWES-9 varied between 0.85 and 0.92 across 10 different countries, including the Netherlands. 74 Work productivity Three items from the Productivity and Disease Questionnaire (PRODISQ) Module E are used to measure productivity losses due to presenteeism. The three items refer to the last work day, and they assess the amount of inefficient job performance, the quality loss of the work, and, if applicable, the reason for productivity loss. 68 Independent measures at baseline As independent measures, we assess demographic characteristics, job characteristics and psychosocial work characteristics at baseline. Demographic characteristics, gender, age (in years), civil status (five categories), and ethnic background (three categories) will be assessed with self-formulated questions. As job characteristics, we will measure the occupation, nursing specialty (if applicable), work experience in years, work hours per week, and type of labor contract. Psychosocial work characteristics will include job demands, job control, social support at work from the supervisor, and social support at work from colleagues, which will each be measured by one self-formulated item on a visual analogue scale (VAS) (0 = not, 100 = to great extent). Additionally, one item will be added for conflicts at work with the supervisor or with colleagues. As possible prognostic factors for help-seeking behavior, we include gender, civil status, 78 informal helpseeking towards family or friends, 79 and previous experiences with mental health care, which is operationalized as having friends or family who were treated by a psychologist/ psychiatrist at any time, or having been treated by a psychologist/psychiatrist himself/ herself at any time. 80 Process indicators measured at three month follow-up Process indicators for the feasibility evaluation of the WHS will be measured at three month follow-up (T1) and include 1) participants compliance in both the OP-care and E-mental health arm; 2) participants satisfaction; 3) adherence of OP to the protocol; and 4) satisfaction of OP. Participants compliance will be assessed by objective data on response rate to the study, percentages of participants who made use of the invitation for an OP consultation or the e-mental health interventions (by track and trace); moreover, 60

62 Study design for evaluation of a mental health module for WHS based on self-report data, the percentages of participants who followed the advice given by the OP or during the e-mental health intervention. Satisfaction of participants will be measured by self-report data on satisfaction with the provided feedback, satisfaction with the invitation for the OP consultation or the e-mental health intervention, satisfaction with the consultation by the OP or e-mental health intervention itself, and satisfaction with the advice given by the OP or given in the e-mental health intervention, including their perceived effectiveness. In the OP-care arm, protocol adherence of the OPs will be assessed by means of a checklist for each protocol step, which the OP has to fill out after each consultation with a participant of the WHS mental module. The OP s satisfaction and experiences with the WHS mental module will be assessed in a group interview after the three month follow-up. Economic evaluation indicators at baseline, three month follow-up and six month follow-up The cost-effectiveness of the WHS mental module will be assessed from a societal perspective. Differences in effect job-specific impairments in work functioning will be compared with differences in costs costs due to intervention and health care and costs stemming from productivity losses in paid work. 3 The employer s perspective will be considered in a cost-benefit analysis by comparing the costs of occupational health care (including the WHS mental module) with the costs due to productivity losses in paid work. Health care utilization will be measured by the Trimbos/iMTA Cost Questionnaire for Psychiatric Illness (TiC-P). 64 Questions on occupational healthcare utilization will be added to this questionnaire for the purpose of this study. The Productivity and Disease Questionnaire (PRODISQ) will be used to measure productivity losses due to absenteeism and presenteeism (inefficient job performance). 68 Sample Size Substudy 1 In a study by Isaaksson Ro 81 on help-seeking behavior in nurses with burnout, the formal help-seeking increased from 17% to 34%. Differences between the percentages of participants having sought formal help between the two study arms will be examined using a Chi-square test. For an increase of 17% with alpha = 0.05 (2-tailed) and a power of (1-beta) = 0.80, power calculation using the Nquery Advisor software results in 114 participants with mental health complaints for each of the two arms. Based on data from a prior study in this population, 44 we assume that 50% of the population will have impairments in either mental health, work functioning or both. Thus, for a comparison of workers screened positive in the control arm and the OP-care arm, 228 participants in each arm are necessary. Randomization will take place at the ward level; however, we do not expect any correlation between wards in the help-seeking behavior of their 61

63 CHAPTER 3 employees. Therefore, no inflation factor is used in the power calculation for Substudy 1 with the outcome measure help-seeking behavior. With an expected loss-to-follow-up of 10%, we must start the trial with N = 228/0.90 = 254 per condition at baseline. Substudy 2 The trial is powered to detect a clinically significant effect, defined as at least 0.33 standard units when the (primary) outcome is transformed into a standardized effect size, also known as Cohen s d or the standardized mean difference. Lipsey and Wilson 82 conducted a second-order meta-analysis of psychological, educational and behavioral interventions and found that for these interventions, d = 0.33 to be corresponding with the lower bound of a medium effect size. We will conduct tests at alpha = 0.05 (2-tailed) and a power of (1-beta) = Using Stata, it is shown that n = 145 per condition is required. For the primary outcome measure of this substudy, work functioning, no information on probable difference on ward-level exists. But as a precaution, we compensate for possible cluster effects introduced into the data because of randomization on ward-level. For cluster correction, we must multiply by a factor 1.3, which returns 145*1.3 = 189 per condition. Assuming a loss-to-follow-up of 10%, we must start the trial with N = 189/0.90 = 210 per condition at baseline. In sum, the required minimum number of participants is 254 for the control arm, 254 for the intervention arm 2 (according to calculations for part 1) and 210 for the intervention arm 2 (according to calculations for Substudy 2); thus, in total, 718 participants are required for all three arms. We expect a response rate of about 45%; thus, 1,596 employees must be invited to recruit the required 718 participants. As we will include 1,731 employees, the source population is large enough to meet the needed sample size. Randomization and blinding In this controlled trial, cluster randomization will be performed at the ward level. The argumentation for cluster randomization is two-fold. First, it prevents contamination effects between participants working in the same department. Second, it is in accordance with the practice of WHS, which is usually conducted for all workers in a department. The randomization procedure will take place before the inclusion of the individual participants. In the randomization, we will stratify for ward size. Randomization will be performed using block randomization with three departments in each block. To guarantee concealment of allocation, the randomization will be performed by one researcher (KN) who is not involved in the practical recruitment of participating employers, using the computer software program Nquery Advisor. 62

64 Study design for evaluation of a mental health module for WHS Researchers, managers of participating departments and OPs will not be blinded for the group allocation. However, as we have a prerandomization procedure with incompletedouble-consent design without mentioning the use of a reference group in the experimental groups and vice versa, 83 the head (nurses) of wards and the individual employees will receive only information that is applicable to the study-arm of their wards. Statistical analyses The baseline data and data of the primary and secondary parameters will be presented using descriptive statistics. The effectiveness of the intervention on the primary and secondary outcome measures will be analyzed on the employee level following the intention-to-treat-principle. Effect evaluation To study the effect on dichotomous outcome measures Chi-square tests will be used; thus, to test differences in proportions of subjects who score positive on the outcome measure between the study arms for each time of measurement. Change of proportion of employees in outcomes at follow-up (T1 and T2) will be analyzed using Generalized Estimated Equations (GEE), with wards and participants as cluster variables (where appropriate) and study-arm, time and their interaction (study-arm x time) as co-variates under the assumptions of an exchangeable working correlation matrix. Effects of demographic characteristics and prognostic factors on dichotomous outcomes measures will also be analyzed using Generalized Estimated Equations (GEE). 3 Effects of continuous outcome measures will be analyzed using multiple regression analysis. A multilevel analysis of variance will be conducted (GLM mixed models, repeated measurements), with ward as the primary hierarchical level and participants as the secondary hierarchical level (where appropriate). Effects of demographic characteristics and prognostic factors on continuous outcome measures will also be analyzed using multiple regression analysis. Cost-effectiveness evaluation For the cost-effectiveness evaluation, the incremental cost-effectiveness ratio (ICER) will be calculated by comparing the differences in costs of health care utilization and productivity losses for each WHS strategy with the difference in effect on job-specific work impairments of both strategies. The index year for health care costs will be Productivity losses will be assessed using the human capital approach. Analyses will include cost-effectiveness planes and acceptability curves. Ancillary analyses (i.e. incremental net-benefit regression analysis) will identify subgroups of workers (e.g. participants with and without impaired work functioning or mental health) who derive particular benefit from the intervention. 63

65 CHAPTER 3 In the cost-benefit analysis, the employer s perspective will be considered by comparing the costs of offering the WHS modules with the costs of productivity losses due to sickness absence (absenteeism) and working less efficiently while at work (presenteeism) for both WHS strategies separately. Process evaluation Participant compliance and participant satisfaction as well as adherence of OP will be presented in proportions. Satisfaction of OPs will be assessed in terms of strengths and suggestions for improvement. Ethical considerations There are no risks associated with participating in the Mental Work study. Confidentiality is guaranteed during the whole study for the employees of all study arms, as no information about the screening or the interventions will be provided to others, such as supervisors. Furthermore, the study participants of all study-arms retain unrestricted access to care as usual if requested. Employees and their supervisors are still free to call in any occupational health care in the medical center if they wish to do so. DISCUSSION The health care service is a sector with special risks for the development of mental health complaints. In turn, in this sector, impaired mental health can have serious consequences for the workers and their patients. A WHS mental module might be an effective preventive action to promote and monitor good (mental) health and work performance in the aging workforce. The aim of the Mental Work study is to test the effectiveness of two strategies for a WHS mental module for nurses and allied health professionals. This paper describes the protocol for a three-arm RCT in which the effectiveness of the two strategies for a WHS mental module will be evaluated. First, the effect on help-seeking behavior for the OP-care arm compared to a control arm and, second, a comparison of the effect on work functioning for the E-mental health arm with the OP-care arm and the control arm. Additionally, an economic evaluation of both procedures will be evaluated from both a societal and employer perspective. WHS is a well-developed strategic concept to protect workers against health risks and to monitor and enhance their work functioning. Mental modules for WHS have been developed in some sectors, e.g. the police sector. 17 In these studies, the identification of workers in need of health care intervention was solely based on the mental health status. The innovative aspect of our approach is that, in addition to screening for mental health problems, a screening for work functioning problems is carried out. The identification of 64

66 Study design for evaluation of a mental health module for WHS work functioning problems in workers with mental health complaints yields input for the kind of intervention needed to enhance work functioning and to prevent more serious consequences such as incidents at work. In line with this, our approach differs from other mental health screenings in the work setting, because we will test the effectiveness of the WHS mental module both at enhancing work functioning and at improving mental health. Another innovative aspect of our study is the included e-mental health interventions. Although the effects of e-mental health interventions on mental health outcomes appear promising, applying them in the context of WHS in a specific working population is a new approach. An advantage of this context is that the e-mental health intervention can be tailored to the mental health outcome of the screening that precedes the offered interventions. 3 Methodological considerations One strength of our RCT-design is the cluster randomization with pre-randomization. Applying a WHS procedure to a ward as a whole is not only in line with WHS in common occupational health service practice, but it also reduces contamination of employees. The pre-randomization approach allows blinding of participants for information of the other study arms. Still, contamination effects due to communication and occasional switching between wards cannot be ruled out completely, as the study is conducted in one organization. One methodological issue to be considered regards our choice for not applying an inflation factor for cluster correction in Substudy 1. This choice is based on two arguments. First, we do not expect any systematic differences between the hospital wards in differences on health seeking behavior of their individual workers, which makes cluster correction illogical. Furthermore, we do not expect any noteworthy differences between the study arms in baseline characteristics, due to the large amount of clusters (N = 86). For work functioning, the primary outcome measure of Substudy 2, the possibility of systematic differences between the wards, is more likely. It is conceivable that improvement in work functioning, e.g. decision making, is more difficult for workers of one ward than workers of another ward, due to differences in work context. Therefore, a cluster correction is applied on Substudy 2. We expect the external validity of this study to be high, as the study is encompassed in a real-life setting. Furthermore, in the set-up of the interventions, good feasibility is allowed for by using input of (nurse) managers and the occupational health service that provides the OP-care. The protocol for the OP consultations is developed based on interviews with the OPs and follows care as usual closely. 65

67 CHAPTER 3 Impact of results The output of the Mental Work study will be two-fold. First, two WHS mental modules for nurses and allied health professionals will be delivered. Based on results on the effectiveness together with results on the process evaluation, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in academic medical centers. A WHS mental module can be used as a stand-alone intervention or as part of a broader WHS program. With minor modifications, the module can be adapted to the context of other healthcare organizations. Secondly, the proposed study will yield valuable knowledge on the effectiveness and cost-effectiveness of a WHS mental module. If it is effective in terms of costs and improvement of adequate help-seeking, work functioning, and improved mental health, the procedure for a WHS mental module will possibly be used as a blue-print and contribute to the development of WHS mental modules in other sectors. It also might promote the use of WHS in the Netherlands. Results of the study will become available in

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70 Study design for evaluation of a mental health module for WHS 48 van Veldhoven M & Meijman TF. The measurement of psychosocial job demands with a questionnaire: the questionnaire on the experience and evaluation of work (QEEW) [In Dutch: Het meten van een psychosociale arbeidsbelasting met een vragenlijst: de vragenlijst beleving en beoordeling van arbeid (VBBA)]. Amsterdam, the Netherlands: Dutch Institute for Working Conditions, de Croon EM, Sluiter JK, Frings-Dresen MH. Psychometric properties of the Need for Recovery after work scale: test-retest reliability and sensitivity to detect change. Occup Environ Med 2006; 63: Sluiter JK, de Croon EM, Meijman TF et al. Need for recovery from work related fatigue and its role in the development and prediction of subjective health complaints. Occup Environ Med 2003; 60 Suppl 1:i62-i van Veldhoven MJ & Sluiter JK. Work-related recovery opportunities: testing scale properties and validity in relation to health. Int Arch Occup Environ Health 2009; 82: Broersen JPJ, Fortuin RJ, Dijkstra L et al. Monitor Arboconvenanten: kengetallen en grenswaarden [Monitor occupational health and safety: key indicators and limits]. TBV 2004; 12: Bush K, Kivlahan DR, McDonell MB et al. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med 1998; 158: Gual A, Segura L, Contel M et al. Audit-3 and audit-4: effectiveness of two short forms of the alcohol use disorders identification test. Alcohol Alcohol 2002; 37: de Beurs E. Brief Symptom Inventory (BSI): Manual [In Dutch: Brief Symptom Inventory (BSI): Handleiding]. Leiden, the Netherlands: Pits Publishers, de Beurs E & Zitman FG. The Brief Symptom Inventory (BSI): The reliability and validity of a brief alternative of the SCL-90 [In Dutch: De Brief Symptom Inventory (BSI): De betrouwbaarheid en validiteit van een handzaam alternatief voor de SCL-90]. Maandblad Geestelijke Volksgezondheid 2006; 61: Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 1999; 282: Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med 2002; 64: Lowe B, Grafe K, Zipfel S et al. Detecting panic disorder in medical and psychosomatic outpatients: comparative validation of the Hospital Anxiety and Depression Scale, the Patient Health Questionnaire, a screening question, and physicians diagnosis. J Psychosom Res 2003; 55: Brom D & Kleber RJ. The Impact of Event Scale [In Dutch: De Schok Verwerkings Lijst]. Nederlands Tijdschrift voor de Psychologie 2011; 40: Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med 1979; 41: van der Ploeg E, Mooren TT, Kleber RJ et al. Construct validation of the Dutch version of the impact of event scale. Psychol Assess 2004; 16: Chemtob CM, Tomas S, Law W et al. Postdisaster psychosocial intervention: a field study of the impact of debriefing on psychological distress. Am J Psychiatry 1997; 154: Hakkaart-van Roijen L, van Straten A, Donker M. Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). Rotterdam, the Netherlands: imta, Rickwood D, Deane FP, Wilson CJ et al. Young people s help-seeking for mental health problems. AeJAMH 2005; 4: Walters K, Buszewicz M, Weich S et al. Help-seeking preferences for psychological distress in primary care: effect of current mental state. Br J Gen Pract 2008; 58: Wilson CJ, Deane FP, Ciarrochi J et al. Measuring Help-Seeking Intentions: Properties of the General Help-Seeking Questionnaire. Can J Counsell 2005; 39: Koopmanschap MA. PRODISQ: a modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res 2005; 5: Tuomi K, Ilmarinen J, Jahkola A et al. Work Ability Index. 2nd revised ed. Helsinki, Finland: Finnish Institute of Occupational Health, Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav 2002; 43:

71 CHAPTER 3 71 Lamers SMA, Westerhof GJ, Bohlmeijer ET et al. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol 2011; 67: Westerhof GJ & Keyes CLM. Mental health is more then the absence of disease [In Dutch: Geestelijke gezondheid is meer dan de afwezigheid van ziekte]. Maandblad Geestelijke Gezondheid 2008; 10: Bech P, Olsen LR, Kjoller M et al. Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res 2003; 12: Schaufeli WB, Bakker AB, Salanova M. The Measurement of Work Engagement With a Short Questionnaire: A Cross-National Study. Educ Psychol Meas 2006; Galdas PM, Cheater F, Marshall P. Men and health help-seeking behaviour: literature review. J Adv Nurs 2005; 49: Judd F, Komiti A, Jackson H. How does being female assist help-seeking for mental health problems? Aust N Z J Psychiatry 2008; 42: Moller-Leimkuhler AM. Barriers to help-seeking by men: a review of sociocultural and clinical literature with particular reference to depression. J Affect Disord 2002; 71: Gudmundsdottir G & Vilhjalmsson R. Group differences in outpatient help-seeking for psychological distress: results from a national prospective study of Icelanders. Scand J Public Health 2010; 38: Rudell K, Bhui K, Priebe S. Do alternative help-seeking strategies affect primary care service use? A survey of help-seeking for mental distress. BMC Public Health 2008; 8: Schomerus G, Matschinger H, Angermeyer MC. The stigma of psychiatric treatment and help-seeking intentions for depression. Eur Arch Psychiatry Clin Neurosci 2009; 259: Isaksson Ro KE, Gude T, Tyssen R et al. A self-referral preventive intervention for burnout among Norwegian nurses: one-year follow-up study. Patient Educ Couns 2010; 78: Lipsey MW & Wilson DB. The efficacy of psychological, educational, and behavioral treatment. Confirmation from meta-analysis. Am Psychol 1993; 48: Schellings R, Kessels AG, ter Riet RG et al. Indications and requirements for the use of prerandomization. J Clin Epidemiol 2009; 62:

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74 4 MENTAL WORK - A WORKERS HEALTH SURVEILLANCE MENTAL MODULE FOR NURSES AND ALLIED HEALTH CARE PROFESSIONALS: PROCESS EVALUATION OF A RANDOMIZED CONTROLLED TRIAL Sarah M. Ketelaar Fania R. Gärtner Linda Bolier Odile Smeets Karen Nieuwenhuijsen Judith K. Sluiter J Occup Environ Med 2013; 55:

75 CHAPTER 4 ABSTRACT Objective: To evaluate the process of workers health surveillance (WHS) targeting work functioning and mental health of health care professionals, alongside a randomized controlled trial comparing two strategies. Methods: Nurses and allied health care professionals working in one hospital were invited. Process indicators were assessed using methods such as questionnaires and trackand-trace data. Results: All participants (32%; N = 369) received screening and personalized feedback. In group 1, 41% went to a preventive consultation with their occupational physician. Protocol adherence of participating occupational physicians (n = 5) was high. They regarded the WHS mental module to be meaningful. In group 2, 16% logged into an e-mental health intervention. Most participants would appreciate a future offer of the WHS. Conclusions: The WHS mental module was well received, and fitted in the occupational health service activities. Nevertheless, response and compliance should be improved. 74

76 Process evaluation of a mental health module for WHS Working in health care places high mental demands on employees (e.g. Suresh et al., 1 Magnavita et al., 2 Buurman et al., 3 Oginska-Bulik. 4 Nurses, the largest occupational group in hospitals, are at higher risk of developing mental health problems than other human service and other health care workers. 5 Not only does their work pose a threat to their mental health but suffering from mental health complaints also impairs their work functioning. Gärtner and colleagues 6 showed that when nurses have impaired mental health, impairments in various aspects of their work functioning may also exist, including task-related, intrapersonal, and interpersonal aspects. Furthermore, impairments in work functioning can have serious effects not only for the nurses themselves but also for patients and their safety. 7 Adding to this, the shortage of nurses 8 increases the importance of sustainable labor participation. Consequently, it is essential to keep nurses mentally fit so they can continue to meet the high mental demands of modern-day work. In the Netherlands, the occupational health care that is provided for employees with mental health problems can be considered effective. Care, according to the occupational physicians (OPs ) guidelines for treating employees who are absent from work because of impaired mental health, has been demonstrated to improve mental health and to facilitate return to work. 9,10 Nevertheless, employees often do not seek help for their mental health complaints, and the occupational health service (OHS) in the Netherlands often does not come into view until the employee is sick-listed. To ensure that early help can be provided before impaired work functioning and mental health problems worsen to the extent that employees cause serious incidents or call in sick, preventive actions are needed. Early identification of impaired work functioning and mental health complaints to provide timely help may be a first step in the prevention of more serious consequences for the mental health and safety of nurses and their patients. 4 One possible strategy for the early identification of impaired work functioning and mental health complaints is to periodically offer employees a mental module of a workers health surveillance (WHS). The WHS is an important component in the practice of occupational health care. It aims to detect negative health effects of work at an early stage to enable timely interventions. 11 Legislation in the Netherlands dictates that employers should periodically enable employees to undergo such an examination that is aimed at preventing or reducing the risks that the work poses for the employee health. Little is known about WHS targeting mental health effects (e.g. Plat et al. 12 ). With a WHS mental module, help-seeking behavior might be stimulated and work functioning and mental health might be improved. The Mental Work study was developed to examine the effects of a job-specific WHS mental module for nurses and allied health care professionals on help-seeking behavior, work functioning, mental health, and well-being by means of a cluster-randomized controlled trial design. 13 The WHS mental module 75

77 CHAPTER 4 combined screening and personalized feedback with interventions. Two different strategies were compared: a strategy in which an OP was involved, and an e-mental health care (EMH-care) strategy in which a tailored choice of online self-help mental health interventions was offered immediately after online screening. The effectiveness and cost-effectiveness of these two strategies on the study outcomes are presented in a separate article. This process evaluation was performed alongside the Mental Work study to offer insight into the black box of the intervention The process evaluation offers more detailed information on the content of the intervention, and can shed light on the extent to which the intervention was applied to the targeted population as intended (e.g. compliance, adherence, satisfaction). Furthermore, it can offer insight into the factors of success and failure of the intervention and thus provide possible targets to improve the intervention. 17 To gain insight into the two interventions that were compared in the Mental Work study, the following aims were formulated for the process evaluation: 1. To describe the participants response and compliance to the intervention 2. To describe the participants perspectives on the WHS mental module 3. To describe the OPs adherence to the consultation protocol 4. To describe the OPs perspectives on the WHS mental module METHODS Study design The Mental Work study was designed as a cluster-randomized controlled trial, with block randomization carried out at ward level. 13 The complete trial, described by Gärtner and colleagues, 13 included two intervention groups and one control group. This process evaluation focuses on the two intervention groups: 1) the occupational physician care (OP-care) group, who received screening, personalized feedback, and an invitation for a preventive consultation with an OP, and 2) the EMH-care group, who received screening, personalized feedback, and an invitation to follow an e-mental health intervention. The medical ethics committee of the Academic Medical Center, Amsterdam, approved the trial. All participants gave their written informed consent before taking part in the study. Participants The study population of the complete trial consisted of all nurses, including surgical nurses and anesthetic nurses, and allied health care professionals working in one academic medical center in the Netherlands. All eligible employees were invited to take part in the study, which for the complete trial added up to 1,731 employees working in 86 wards. 76

78 Process evaluation of a mental health module for WHS After randomization, 591 employees were assigned to the OP-care group and 579 employees to the EMH-care group, together working in 57 wards. Participants were included if they were not, or were not expecting to be on sick leave for more than two weeks at the start of the study. Procedure At the start of the study (March 2011), the potential participants received an invitation in their work accounts to take part in the study. It was possible to discontinue the questionnaire and complete it after logging in again, within six weeks. After completing the baseline questionnaire, participants immediately received their personalized feedback electronically, as well as the intervention specific to their study group. The first follow-up questionnaire after three months and the second follow-up questionnaire after six months were sent to the baseline participants. Table 1 Recruitment and information activities. Recruitment and information activities 4 Preceding the start of the study and each follow-up questionnaire Extensive information to nursing directors, head nurses, and managers of allied health care professions Information letter to home address of eligible participants Announcement of a lottery for a wellness weekend voucher (only for follow-up questionnaires) During period in which questionnaires could be filled out Information in employee magazine Posters in staff rooms and public places Banner and information on intranet Giveaways and flyers in staff rooms and public places Three reminders for each questionnaire Reserved computer rooms to facilitate filling out the questionnaire (only for baseline questionnaire) Ad hoc personal assistance if needed (e.g. with logging into questionnaire) Recruitment strategy The board of management of the academic medical center and the works council were informed about all details of the study and gave their consent. An advisory committee was formed with the head of Human Resources, the head of the in-house OHS, a nursing director, and a director of a ward with allied health care professionals. The works council 77

79 CHAPTER 4 and the advisory committee were regularly informed about the progress of the study. All recruitment and information activities that were used during the trial are presented in Table 1. Interventions The OP-care intervention and the EMH-care intervention both consisted of online screening and immediate feedback on personal screening results on work functioning and mental health outcomes, followed by a group-specific intervention. Screening and personalized feedback At baseline, participants were screened on impaired work functioning, distress, work-related fatigue, risky drinking behavior, depression (including suicide risk), anxiety (including panic disorder), and posttraumatic stress disorder (see Table 2 for information on the instruments and cutoff points that were applied). The work relatedness of any mental health complaints was also assessed. The participants received feedback on their personal screening results in two ways: on-screen, immediately after filling out the baseline questionnaire; and in an sent to the address they provided to this end. OP care For participants in the OP-care group who screened positive on impaired work functioning, on any mental health complaints, or on both, the personalized feedback was followed by an invitation for a face-to-face preventive consultation with their own OP, within two weeks. They were then sent a letter, to their home address, with an appointment for this consultation. The consultation was voluntary, and supervisors were not informed about it. A consultation protocol was written, which was based on interviews with the participating OPs to elicit their current practices and on the evidence-based guidelines for OPs treatment of employees with mental health problems. 10,33 It consisted of seven steps: 1) discussing expectations; 2) discussing screening results and the characteristics of work functioning and mental health complaints; 3) discussing possible causes in the private, work, and health condition and consequences for work functioning; 4) identifying the problem and offering rationale; 5) giving advice on how to tackle health complaints, how to improve work functioning, how to prevent consequences of impaired work functioning, and how to communicate with the supervisor about work functioning and mental health; 6) discussing possible follow-up or referral to other health care providers; and 7) summarizing the consultation. All participating OPs received a three-hour training in using the protocol for the consultations. 78

80 Process evaluation of a mental health module for WHS Table 2 Overview of aspects that were screened for, including the used instruments and cutoff points. Aspect Instrument Cutoff point Impaired work functioning Nurses Work Functioning Questionnaire (7 subscales) 18 Red score on 1 or more subscales, orange score on 3 or more subscales, or both 13 Distress Four-Dimensional Symptoms Questionnaire, Distress subscale 19,20 Total score Work-related fatigue Need for Recovery subscale of the Dutch Questionnaire on the Experience and Evaluation of Work 22 Standardized total score Risky drinking behavior Alcohol Use Disorders Identification Test-Consumption 24 Total score 5 for men, 4 for women 25 Depression Brief Symptom Inventory, Depression subscale 26 Mean score Suicide risk One item from Brief Symptom Inventory, Depression subscale 26 Answer on item is rather a lot or extremely Anxiety Brief Symptom Inventory, Anxiety subscale 26 Mean score answers affirmative on the first 4 items, plus 4 symptoms affirmative on the following 11 items 29 Panic disorder Patient Health Questionnaire, 28 only assessed for participants identified as having anxiety complaints Posttraumatic stress disorder Dutch translation of the Impact of Event Scale 30,31 Total score

81 CHAPTER 4 E-mental health care For participants in the EMH-care group, the personalized feedback was followed by a tailored choice of self-help e-mental health interventions. Participants who screened positive on one or more mental health aspects were invited to follow one or more e-mental health interventions. Participants who screened negative on all mental health aspects were invited to follow an e-mental health intervention aimed at enhancing and retaining mental fitness. The e-mental health interventions were developed as stand-alone interventions by the Trimbos Institute (the Netherlands Institute of Mental Health and Addiction) at an earlier stage. The e-mental health interventions were as follows: Psyfit: 34 aimed at enhancing mental fitness. Strong at Work: aimed at gaining insight into work stress and learning skills to cope with work stress. Colour Your Life: aimed at tackling depressive symptoms. Don t Panic Online: aimed at reducing panic symptoms for subclinical and mild cases of panic disorder. Drinking Less: 46,47 aimed at reducing risky drinking behavior. To tailor the specific choice of e-mental health interventions to the individual s work functioning and mental health state, an algorithm was developed by the researchers. For example, if screened positive on (partly) work-related depression, participants were advised to choose one of the following interventions: Colour Your Life, Strong at Work or Psyfit. In case of positive screening on work functioning, participants received an on-screen educational leaflet on how to improve their work functioning. Data collection Several methods were used to collect data for the process evaluation. Table 3 offers a schematic presentation of the process evaluation elements and the methods used to measure these elements. Participants response and compliance to the intervention To determine response, the researchers registered the number of participants who took part in the study. In the OP-care group, whether participants were sent an invitation for a preventive consultation and whether they came to the appointment was recorded by the OHS. Furthermore, three self-report process indicators (prescripted answers) were used to measure compliance (received advice during the preventive consultation and followed this advice, and discussed personalized feedback, advice, or both with supervisor). Reasons were asked for not going to the consultation and not following the OP s advice (open-ended). 80

82 Process evaluation of a mental health module for WHS Table 3 Elements of the process evaluation and the methods used to measure each element. Elements Measurement Registration researchers Registration OHS Checklist OPs Track-and-Trace EMH Quest. after 3 mo Quest. after 6 mo Quest. OPs Interview OPs Participants response X Participants compliance X X X Participants perspectives X X X OPs adherence X X OPs perspectives X X EMH, e-mental health; OHS, occupational health service; OPs, occupational physicians, Quest., questionnaire. 4 Participants in the EMH-care group who logged into an e-mental health intervention were followed using track and trace, which means that the intervention automatically kept track of the activities of the participants in the e-mental health intervention. Whether participants logged into an e-mental health intervention at least once and the number of modules on which they started were used as indicators. Compliance was further assessed with two self-report indicators (prescripted answers) (followed the advice in the on-screen educational leaflet on how to improve work functioning and discussed personalized feedback, advice or both with supervisor). Reasons were asked for choosing a specific e-mental health intervention and for not following an e-mental health intervention (open-ended). Participants could also explain why they did or did not follow the advice on how to improve their work functioning (open-ended). Participants perspectives on the WHS mental module The participants perspectives on the WHS mental module encompassed four aspects. First of all, their perspectives on the preventive consultation and the usefulness of the advice that was given (OP-care group, prescripted answers) and on the e-mental health interventions (EMH-care group, graded) were asked. Second, it was assessed whether they would want to receive their personalized feedback (both groups) and an invitation for their OPs differently in future (OP-care group) (prescripted answers). In addition, the participants perceptions of the effectiveness of the advice that was given by the OP (OP-care group) and of following the e-mental health interventions and the advice on 81

83 CHAPTER 4 how to improve work functioning (EMH-care group) were asked (prescripted answers). Last, participants in both groups were asked about their preferences regarding future implementation of the WHS mental module (prescripted answers). For participants in the OP-care group who came to the preventive consultation, the OPs recorded whether the participants felt that their screening results indeed reflected their mental health condition and work functioning (completely/partially/not). OPs protocol adherence The OPs filled out a checklist for each preventive consultation they held, containing four questions with prescripted answers (completion of each step of the consultation protocol, advice given to the employee, referral of the employee, and scheduled follow-up). In addition, the OHS recorded how many follow-up consultations the participants went to in the six months after baseline. OPs perspectives on the WHS mental module The OPs perspectives encompassed their perspectives on the WHS mental module as performed in the study and their perspective and preferences regarding future implementation of a WHS mental module. These aspects were measured by means of a short questionnaire and a semistructured group interview, after all the preventive consultations had taken place. Statistical analyses The analyses were performed using the statistical package Predictive Analytics SoftWare Statistics 18 (SPSS Inc., Chicago, IL) and Microsoft Office Excel Numerical data were analyzed using descriptive statistics. To facilitate interpretation of open-ended questions, answers that were similar were clustered. For each cluster, the proportion of the total number of answers on that question was calculated. For the results of the semistructured group interview with the participating OPs, a summary was given per question and presented as a written description. RESULTS Participants response In total, 191 participants (32%) in the OP-care group and 178 (31%) in the EMH-care group finished the baseline questionnaire and were included in the analyses. Baseline characteristics are shown in Table 4. There were 82% and 83% women in the OP-care group and the EMH-care group, respectively. The average age of the participants was 43 years in the OP-care group and 37 years in the EMH-care group. In both the groups, nurses constituted the largest number of participants (61% vs 73%). 82

84 Process evaluation of a mental health module for WHS Table 4 Baseline characteristics of study participants. OP-care (n = 191) EMH-care (n = 178) n % n % Sex Women Age, yr Occupation Nurse Nurse practitioner Surgical nurse Anesthetic nurse Allied health care professionals Other OP, occupational physician. In the OP-care group, 151 participants (79%) screened positive on impaired work functioning, impaired mental health, or both and were eligible for a preventive consultation. Because of a technical and organizational error, 26 of the 151 participants who screened positive (17%) were not invited to the OHS. Consequently, 125 participants (65% of the total group) were invited to the OHS for a consultation. In the EMH-care group, 61% screened positive on impaired mental health and were invited to follow one or more e-mental health interventions. Those who screened negative on all mental health aspects (39%) were offered to follow Psyfit, to retain or enhance their mental fitness. Sixty percent screened positive on impaired work functioning and received the on-screen educational leaflet on how to improve their work functioning. A large overlap existed in those who screened positive on impaired work functioning and those who screened positive on impaired mental health: 139 participants (78%) screened positive on either impaired work functioning or impaired mental health or both. After the baseline questionnaire, it was discovered that five men in the OP-care group and 12 men in the EMH-care group who scored more than the cutoff point on risky drinking behavior accidentally were not classified as such by the technical system. For two and 83

85 CHAPTER 4 nine of these participants, respectively, risky drinking behavior was the only aspect they screened positive on. Thus, risky drinking behavior was not mentioned in their personalized feedback, and for those in the EMH-care group, they were invited for Psyfit instead of Drinking Less. Participants compliance All 369 participants received the first part of the intervention, consisting of screening and personalized feedback. The OHS recorded that 51 of the 125 invited participants in the OP-care group (41%) came to the preventive consultation. Most participants (80%) reported not to have gone to the consultation because they regarded it as unnecessary. Of those who went and received an advice from his or her OP, 80% followed that advice (see Table 5). Reasons reported for not following the advice were that participants regarded it as unnecessary (n = 2) or lack of time (n = 1). Track-and-trace data (see Table 6) showed that 28 of the 178 participants in the EMH-care group (16%) logged on at least once in one or more e-mental health interventions. Five participants logged into two e-mental health interventions. Nine participants (5%) started one or more of the modules of which the e-mental health interventions consisted of (six participants started with Psyfit and three with Colour Your Life); the other 19 participants merely logged in and did not start any of the intervention modules. Participants in the EMH-care group chose an e-mental health intervention that fitted their complaints the best. No reasons were reported for not following an e-mental health intervention. Five participants reported to have followed the advice in the on-screen educational leaflet on how to improve work functioning (see Table 5). Not following the advice because it was regarded as unnecessary was the most reported reason. Participants perspectives on the study In Table 7, the participants evaluation of the WHS mental module as performed in this study and the perceived effectiveness of the interventions are shown. Among the participants, 13% in the OP-care group and 17% in the EMH-care group would rather receive their personalized feedback differently in the future. Of the participants in the OP-care group who came to the preventive consultation, 79% felt that the personalized feedback reflected their mental health condition and 70% felt that the personalized feedback reflected their work functioning (partially or completely), according to their OPs. Almost all of the participants who came to the consultation (97%) felt that they could be open and honest with their OPs about their condition. Four participants in the EMH-care group graded the e-mental health interventions (range, 1-8). In the OP-care group, nine of 15 participants felt that the advice helped improve their mental health, work functioning or both. 84

86 Process evaluation of a mental health module for WHS Table 5 Compliance of participants per study group, based on self-report data. OP-care Participants in OP-care group (n = 191) Reported to have discussed personalized feedback, advice from OP, or both with supervisor n % Yes No Received invitation from the OHS for consultation (n = 125) Reported reasons for not going to consultation Went to consultation (n = 51) Reported to have received advice from OP on improving mental health, work functioning, or both Yes No Reported to have followed advice on improving mental health, work functioning, or both Yes No EMH-care Participants in EMH-care group (n = 178) Reported to have discussed personalized feedback, advice, or both with supervisor Yes 9 11 No Received on-screen educational leaflet on how to improve work functioning (n = 107) Reported to have followed advice in leaflet Yes 5 23 No Explanation on following advice in leaflet EMH, e-mental health; OHS, occupational health service; OP, occupational physician. 85

87 CHAPTER 4 Table 6 Track-and-trace data on participants compliance to the intervention. Strong at Work (8 modules) EMH-care (n = 178) Modules started on n Median Range Logged on at least once Colour Your life (8 modules) Logged on at least once Don t Panic Online (6 modules) Logged on at least once Drinking Less (4 modules) Logged on at least once Psyfit (6 modules) Logged on at least once % Followed Psyfit a Minimum Maximum Started on module 1 (Feeling positive) 4 (11) (56) Started on module 2 (Positive relationships) 1 (25) (25) Started on module 3 (Here and now) 2 (32) (32) Started on module 4 (Thinking and feeling) 2 (5) (37) Started on module 5 (Grip on your life) 3 (4) (44) Started on module 6 (Mission and goals) 2 (30) (40) a For Psyfit, data are also shown separately per module, because it is the only e-mental health intervention for which modules can be followed separately (e.g. it is not necessary to finish module 1 to start with module 2). The minimum and maximum percentages that was followed of each module are given for the people who started that specific module. Participants preferences for future implementation and the WHS mental module are shown in Table 8. In the OP-care group, 79% would or would maybe appreciate to be periodically offered a WHS in the future, versus 74% in the EMH-care group. Most of the participants in both groups (74% vs 67%) would prefer to receive their personalized feedback on the computer or by . Preferences regarding how to receive advice to retain mental health and healthy work functioning differed between the study groups. The largest number of participants in the OP-care group (32%) prefers to receive advice through e-mental health interventions, while the largest number of participants in the EMH-care group (37%) prefer to receive advice in a personal consultation with their OP. In both the groups, most participants (60% vs 62%) prefer to make an appointment with their OP themselves. 86

88 Process evaluation of a mental health module for WHS Table 7 Participants evaluation and perceived effectiveness of the WHS mental module, self-report data. Evaluation of the WHS mental module as performed in this study OP-care Receipt of personalized feedback (n = 126) Range n % Would rather receive personalized feedback differently in the future Personalized feedback reflected mental health condition (not self-reported a ) (n = 42) Completely Partially No 9 21 Personalized feedback reflected work functioning (not self-reported a ) (n = 46) Completely Partially 6 13 No Receipt of invitation for preventive consultation (n = 64) Would rather receive invitation differently in the future Preventive consultation Felt that they could be open and honest during consultation (n = 38) Found the advice that was given useful (n = 21) EMH-care Receipt of personalized feedback (n = 82) Would rather receive personalized feedback differently in the future E-mental health interventions (n = 4) Grade given to e-mental health interventions (1, bad; 10, good) 1-8 Perceived effectiveness of the interventions OP-care Following OPs advice helped improve mental health, work functioning, or both (n = 15) EMH-care Following e-mental health intervention(s) helped improve mental health, work functioning, or both (n = 4) Following advice on how to improve work functioning helped improve it (n = 5) a This was not self-reported by the participants, but by the OPs when the participant had come to the consultation. OP, occupational physician; WHS, workers health surveillance. 87

89 CHAPTER 4 Table 8 Participants preferences regarding future implementation of a WHS mental module, self-report data. OP-care EMH-care n % n % Would appreciate periodical offer of WHS Yes Maybe No Would participate in a WHS aimed at mental health and work functioning Yes Maybe No Preference to receive personalized feedback Immediately by the computer, by , or by both In a personal consultation with OP Otherwise Preference to receive tailored advice Personal consultation with OP E-mental health interventions Personal consultation with OP, with opportunity to follow e-mental health interventions Through other in-house health care providers Through other external health care providers Preference for a consultation with OP Make an appointment Receive an invitation for an appointment that is made OP, occupational physician; WHS, workers health surveillance. OPs protocol adherence In most consultations, all seven steps of the protocol were followed (Table 9). Expectations about the preventive consultations (step 1) were discussed in each consultation, as well as the possible causes and consequences of impaired mental health and impaired work functioning (step 3). The OPs gave advice in 61% of the 51 consultations. In the remaining 20 consultations, the OPs regarded giving advice to be unnecessary. Ten participants were referred to other health care providers, of whom four were referred to a company welfare worker and two to a psychologist. Five employees had another follow-up consultation with the OP within six months after baseline. 88

90 Process evaluation of a mental health module for WHS Table 9 Adherence of OPs to protocol during preventive consultations (n = 51). Elements of protocol adherence Median Range Adherence to protocol steps Number of protocol steps followed n % Adherence to protocol, per step Step 1: expectations discussed Step 2: screening results discussed Step 3: causes and consequences discussed Step 4: problem diagnosis and rationale discussed Step 5: advice discussed Step 6: follow-up discussed Step 7: summary discussed Advice given to employee Yes, advice given Yes, aimed at both the person or the complaints and work functioning Yes, aimed at work functioning Yes, aimed at the person or the complaints 5 10 No, no advice given Advice was not needed Did not get round to this step Referral of the employee Employee was referred to other health care provider Follow-up Follow-up appointment not planned If needed, the employee can make another appointment 4 8 Follow-up consultation planned within next (6 wks; 4 wks) 2 4 Contact by telephone or within next 4 wks 1 2 OPs perspectives on the WHS mental module Three of the five participating OPs found that the training prepared them well for the preventive consultations. Three OPs regarded all steps of the protocol for the consultations as useful and performable. All in all, the protocol was regarded to be of use and to fit their method of working. 89

91 CHAPTER 4 Discussing the personalized feedback on screening results seemed to be sensitive because of participants lack of identification with their personalized feedback. The OPs felt that it was important to clarify to the participants that their symptoms might be very light, thus might not be experienced as an impairment. Nevertheless, the OPs also doubted the quality of the screening instruments and the cutoff points that were used in the study, particularly the one used for risky drinking behavior. More than half of the participants did not come to the appointment, making it difficult for the OPs to plan their time efficiently. A solution would be to let employees make their own appointments. The OPs perceived the supervisors and managers knowledge and acceptance of the study to be marginal and found that the organization did not seem ready for implementing a WHS mental module. According to the OPs, the resistance of supervisors and managers stemmed from fear to be complained about during the consultation with the OP. The OPs regarded the preventive consultations to be meaningful. For roughly 50% of the consultations, the OPs could mean something to the employees immediately. Nevertheless, for the other half of consultations it was also useful, as an introduction to occupational health care and to improve the image of the OHS. The OPs were asked about their perspectives and preferences regarding future implementation of a WHS mental module. Most OPs regarded future implementation as meaningful if the WHS mental module would be adapted. Most regarded the chance to be considerable that implementation would be successful. The in-house communication could be improved by repeatedly informing all layers of the organization and assessing whether the message has come across. The OPs thought that they should play an active role in this communication and that they could be responsible for personally informing the medical divisions and wards. Another point to consider, according to the OPs, was the phrasing of personalized feedback, which could be improved in the future to facilitate employees interpretations. DISCUSSION Response of the OP-care group and the EMH-care group was 32%. All participants received the first part of the intervention, consisting of screening and personalized feedback. Of the invited participants in the OP-care group, 41% went to the preventive consultation and 80% followed the OP s advice if this was given. In the EMH-care group, 16% of the participants logged into an e-mental health intervention and 5% started it, at least to some extent. The advice on improving work functioning, given in an on-screen educational leaflet, was followed by 23% of the participants who received it. Of the participants in the 90

92 Process evaluation of a mental health module for WHS OP-care group and in the EMH-care group, 13% and 17%, respectively, would rather receive the personalized feedback on their screening results differently in the future. The OPs rated that 70% to 80% of the participants who came to the consultation felt that the personalized feedback reflected their work functioning and mental health. Moreover, of the participants who came to the consultation, almost everyone felt that they could be open and honest with their OP. The preventive consultation was perceived effective by nine of 15 participants. In both the groups, most participants would appreciate to be offered a WHS in the future. The adherence of OPs to the consultation protocol was high, as in most cases all steps were followed. The OPs were satisfied with the consultation protocol and training and felt that the preventive consultations had been meaningful. They also considered it to be meaningful to implement a WHS mental module in the future. For each participant who came to the preventive consultation, OPs registered whether the participants felt that their personalized feedback on screening results reflected their mental health condition and work functioning. This was used as one of the process indicators of participants evaluation of the WHS mental module. It would have been more accurate to assess this indicator at the employee level rather than the OP level for two reasons: the information would have been received of both groups and not only of the OP-care group, and it would have given a more accurate evaluation because it would not have been given through another person. 4 Recruitment for the study was time-consuming. Nevertheless, it was found useful, as a surge in participation was observed after most of the recruitment activities. The response rate in this study is similar to that in other studies in which employees were screened on mental health complaints or on general health risks. 51 Some of the reasons that were given for not participating in this study were feeling overloaded with research (because the employees of the academic medical center are asked to take part in many other research projects), fear of privacy (although anonymity of their enrolment was stressed), and the extensive questionnaire (it took about 30 minutes to fill out). Furthermore, in general, personal benefit is important in the decision to participate in research. 52 The study might have attracted employees who felt that reflection on work functioning and mental health and a possible intervention would be useful or necessary to them. This idea is supported by the high percentages in both groups who screened positive on impaired work functioning, impaired mental health, or both. An important aspect to discuss here is the difference between the two study groups in compliance of the participants to the intervention. In the OP-care group, compliance was fairly high. It was not expected that everyone would come to the consultation with their 91

93 CHAPTER 4 OP when invited, because the offer of the consultation had a preventive nature. Nevertheless, compliance in the EMH-care group was low. Self-help e-mental health interventions often have shown to have low compliance rates. 53 In a study with participants who wanted to work on their depressive complaints, 35 it was found that of the people who were randomized to follow the e-mental health intervention Colour Your Life, 36% followed it to an adequate extent (at least five sessions). In a further study, 54 several barriers were identified that participants of Colour Your Life experienced, such as experiencing a lack of identification with and applicability of the e-mental health intervention and inadequate computer and Internet skills, equipment, or location. It is possible that these aspects played a role in the low compliance of the nurses and allied health care professionals in this study. We observed that some of the participants experienced problems with logging into the interventions, because of not only inadequate computer skills but also technical problems. A further barrier might have been that nurses and allied health care professionals are people-oriented employees, possibly making e-mental health interventions too impersonal for them. Last, this study regarded a preventive setting in which the e-mental health interventions were offered without the participants specifically asking for any intervention. To our knowledge, using e-mental health interventions in a preventive WHS setting for health care employees has not been researched before. It should be investigated how the e-mental health interventions can be improved to make them more appealing for nurses and allied health care professionals and to increase compliance. Nevertheless, we expected that undergoing screening and receiving personalized feedback would form an intervention in itself, because it might be encouraging to think about one s own work functioning and mental health and to seek help if needed. A possible improvement of the WHS mental module would be to combine the two strategies that were compared in this study. The employees could be screened online and given feedback on their personal screening results on-screen or through as found preferred by the participants. They could then either choose to see their OP in a preventive consultation or choose to start an e-mental health intervention. For a preventive consultation, the participants in this study prefer to make an appointment with their OPs themselves, which was also suggested by the OPs as an adaptation of the WHS mental module. The combination of the OP-care and the EMH-care would fit the participants preferences found in this study. In the preventive consultation, the OPs could also offer an e-mental health intervention (possibly under the guidance of the OP), if this is deemed appropriate and if it suits the employee s preference. This would also make the WHS mental module more personal and possibly more suited to nurses and allied health care professionals. 92

94 Process evaluation of a mental health module for WHS CONCLUSIONS It is possible to include a WHS mental module for nurses and allied health care professionals in the OHS activities. The WHS mental module was well received by the nurses and allied health care professionals who participated in the study. It should be investigated how to improve the response and the compliance to the intervention. 4 93

95 CHAPTER 4 REFERENCES 1 Suresh P, Matthews A, Coyne I. Stress and stressors in the clinical environment: a comparative study of fourth-year student nurses and newly qualified general nurses in Ireland. J Clin Nurs 2013; 22: Magnavita N & Heponiemi T. Violence towards health care workers in a Public Health Care Facility in Italy: a repeated cross-sectional study. BMC Health Serv Res 2012; 12: Buurman BM, Mank AP, Beijer HJ, Olff M. Coping with serious events at work: a study of traumatic stress among nurses. J Am Psychiatr Nurses Assoc 2011; 17: Oginska-Bulik N. Occupational stress and its consequences in healthcare professionals: the role of type D personality. Int J Occup Med Environ Health 2006; 19: Wieclaw J, Agerbo E, Mortensen PB, Bonde JP. Risk of affective and stress related disorders among employees in human service professions. Occup Environ Med 2006; 63: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. The impact of common mental disorders on the work functioning of nurses and allied health professionals: A systematic review. Int J Nurs Stud 2010; 47: Letvak SA, Ruhm CJ, Gupta SN. Nurses presenteeism and its effects on self-reported quality of care and costs. Am J Nurs 2012; 112: Juraschek SP, Zhang X, Ranganathan V, Lin VW. United States registered nurse workforce report card and shortage forecast. Am J Med Qual 2012; 27: Nieuwenhuijsen K, Verbeek JH, de Boer AG et al. Validation of performance indicators for rehabilitation of workers with mental health problems. Med Care 2005; 43: van der Klink JJ, Blonk RW, Schene AH, van Dijk FJ. Reducing long term sickness absence by an activating intervention in adjustment disorders: a cluster randomised controlled design. Occup Environ Med 2003; 60: Koh D & Aw TC. Surveillance in occupational health. Occup Environ Med 2003; 60: Plat MJ, Frings-Dresen MH, Sluiter JK. A systematic review of job-specific workers health surveillance activities for fire-fighting, ambulance, police and military personnel. Int Arch Occup Environ Health 2011; 84: Gärtner FR, Ketelaar SM, Smeets O et al. The Mental Work study: design of a randomized controlled trial on the effect of a workers health surveillance mental module for nurses and allied health professionals. BMC Public Health 2011; 11: Linnan L & Steckler A. Process evaluation for public health interventions and research: an overview. In: Process Evaluation for Public Health Interventions and Research. San Francisco: Jossey-Bass, 2002; Bouffard JA, Taxman FS, Silverman R. Improving process evaluations of correctional programs by using a comprehensive evaluation methodology. Evaluation and Program Planning 2003; 26: Nielsen K, Fredslund H, Christensen KB, Albertsen K. Success or failure? Interpreting and understanding the impact of interventions in four similar worksites. Work Stress 2006; 20: Hulscher ME, Laurant MG, Grol RP. Process evaluation on quality improvement interventions. Qual Saf Health Care 2003; 12: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: Terluin B. The Four Dimensional Symptom Questionnaire (4DSQ) [in Dutch: De Vierdimensionele Klachtenlijst (4DKL) in de huisartspraktijk]. De Psycholoog 1998; 33: Terluin B, van Marwijk HW, Ader HJ et al. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry 2006; 6: van Rhenen W, van Dijk FJ, Schaufeli WB, Blonk RW. Distress or no distress, that s the question: A cutoff point for distress in a working population. J Occup Med Toxicol 2008; 3:3. 22 van Veldhoven M & Meijman T. The measurement of psychosocial job demands with a questionnaire: the questionnaire on the experience and evaluation of work (QEEW) [in Dutch: Het meten van een psychosociale arbeidsbelasting met een vragenlijst: de vragenlijst beleving en beoordeling van arbeid (VBBA)]. Amsterdam, the Netherlands: Dutch Institute for Working Conditions,

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97 CHAPTER 4 45 van Ballegooijen W, Riper H, van Straten A et al. The effects of an Internet based self-help course for reducing panic symptoms - Don t Panic Online: study protocol for a randomised controlled trial. Trials 2011; 12: Kramer J, Riper H, Lemmers L et al. Television-supported self-help for problem drinkers: a randomized pragmatic trial. Addict Behav 2009; 34: Riper H, Kramer J, Smit F et al. Web-based self-help for problem drinkers: a pragmatic randomized trial. Addiction 2008; 103: Harvey SB, Glozier N, Henderson M et al. Depression and work performance: an ecological study using web-based screening. Occup Med (Lond) 2011; 61: Lexis MA, Jansen NW, Huibers MJ et al. Prevention of long-term sickness absence and major depression in high-risk employees: a randomised controlled trial. Occup Environ Med 2011; 68: Wang PS, Simon GE, Avorn J et al. Telephone Screening, Outreach, and Care Management for Depressed Workers and Impact on Clinical and Work Productivity Outcomes. JAMA 2007; 298: Colkesen EB, Kraaijenhagen RA, Frings-Dresen MH et al. Participation in a workplace web-based health risk assessment program. Occup Med (Lond) 2011; 61: Cook AF & Hoas H. Trading Places: What the Research Participant Can Tell the Investigator about Informed Consent. J Clinic Res Bioeth 2011; 2: Eysenbach G. The law of attrition. J Med Internet Res 2005; 7:e Gerhards SA, Abma TA, Arntz A et al. Improving adherence and effectiveness of computerised cognitive behavioural therapy without support for depression: a qualitative study on patient experiences. J Affect Disord 2011; 129:

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100 5 MENTAL WORK: THE EFFECTIVENESS OF A MENTAL MODULE FOR WORKERS HEALTH SURVEILLANCE FOR NURSES AND ALLIED HEALTH PROFESSIONALS, COMPARING TWO APPROACHES IN A CLUSTER-RANDOMISED CONTROLLED TRIAL Sarah M. Ketelaar Karen Nieuwenhuijsen Fania R. Gärtner Linda Bolier Odile Smeets Judith K. Sluiter Int Arch Occup Environ Health 2014; 87:

101 CHAPTER 5 ABSTRACT Purpose: The aim of this study was to compare two approaches for a worker s health surveillance (WHS) mental module on work functioning and work-related mental health. Methods: Nurses and allied health professionals from one organisation were clusterrandomised at ward level to e-mental health care (EMH) (N = 579) or occupational physician care (OP) (N = 591). Both groups received screening and personalised feedback on impaired work functioning and mental health. Positively screened participants received an invitation to follow a self-help EMH intervention, or for a consultation with an OP. The primary outcome was impaired work functioning. Follow-up was performed after three and six months. Linear mixed models were applied to determine differences. Noninferiority of the EMH-care approach was demonstrated if the mean absolute improvement on work functioning in the OP-care group was 10 points higher than the EMH-care group. Results: Analyses were performed on the positively screened participants (almost 80%) (EMH N = 75; OP N = 108) and all participants (EMH N = 98; OP N = 142). Both groups improved over time regarding impaired work functioning. A considerable percentage of participants had improved relevantly at follow-up regarding work functioning (3 months: EMH 30%, OP 46%; 6 months: EMH 36%, OP 41%) compared to baseline. No statistically significant differences were found between the groups, and the difference did not exceed the pre-defined criterion for non-inferiority. Conclusion: The OP-care approach for a WHS mental module trended towards better performance in targeting work functioning, but our findings indicate that the EMH-care approach was non-inferior. However, the high dropout rate and low compliance to EMH interventions should be taken into account. 100

102 Effectiveness of a mental health module for WHS, comparing two approaches INTRODUCTION In nurses, mental health problems are highly prevalent. 1,2 Impaired mental health can have serious adverse effects, not only on the nurses themselves but also on their patients. Letvak et al. 3 found that depression in nurses was associated with presenteeism, which is associated with patient falls, medication errors and lower self-reported quality of care. Moreover, Gärtner et al. 4 found that common mental disorders in nurses and allied health professionals affect several aspects of their work functioning. Consequently, it is essential to monitor and promote nurses and allied health professionals mental health and work functioning. Preventive interventions aimed at early recognition and treatment of mental health problems are called for. The focus in the current study is on preventive workers health surveillance (WHS) as a means to put preventive interventions into action. WHS is an important part of occupational health services. 5 It can be used to periodically monitor employees health and work functioning to detect impairments early and to bring timely interventions into action to prevent further impairment. In order to be able to tailor the intervention to the specific detected work functioning impairments as much as possible, a job-specific assessment for nurses and allied health professionals should be applied. 6 To our knowledge, WHS targeting work functioning and mental health of nurses and allied health professionals has not been reported before. 5 If available, occupational health services form a natural platform for WHS. In the Netherlands, WHS is generally performed by occupational physicians. The occupational physician initiates and performs the screening and subsequently offers advice and possible interventions. 7 The approach, consisting of online screening, online personalised feedback, and in the case of impairments in work functioning and/or mental health an invitation for a preventive consultation with an occupational physician, was successful in improving work functioning in the same population. 8 In this paper, a self-help e-mental health approach for WHS is compared to this conventional approach. E-mental health interventions exist that target a wide variety of common mental disorders such as depression, anxiety, panic, phobias and various addictions. The extent of self-help varies, some being completely without guidance and some including a certain amount of guidance by a caregiver. Research has shown unguided self-help e-mental health interventions to have positive outcomes for a variety of mental health aspects (e.g. Billings et al., 9 Riper et al., 10 Warmerdam et al. 11 ), although to our knowledge, their effects on work functioning have not been studied in a specific working population such as nurses and allied health professionals. Self-help e-mental health interventions may offer some advantages over face-to-face healthcare, e.g., they can be followed in a self-chosen time and place and at one s own pace. Furthermore, people might not seek help due to 101

103 CHAPTER 5 concerns about being stigmatised, 12 which e-mental health might help to avoid. E-mental health might also reach a target population who would otherwise not seek help, for instance, people who find it difficult to talk about, or who are ashamed of their problems. The aim of this cluster-randomised controlled trial, therefore, is to compare this novel e-mental health approach for WHS targeting work functioning and mental health to a more conventional approach performed by an occupational physician. 13 As in both approaches the online screening and personalised feedback are combined with interventions which can be expected to be effective, we hypothesise that the e-mental health approach will not be inferior to the occupational physician approach in its effect on work functioning and work-related mental health outcomes. METHODS Study design The study was designed as a cluster-randomised trial with block randomisation carried out at ward level. 13 To guarantee allocation concealment, randomisation was performed by one researcher (KN) who was not involved in the practical recruitment of employees, using the computer software program Nquery Advisor with a block size of three. The complete trial, described in Gärtner et al., 13 included two intervention groups and one control group. The present study compared the effectiveness of the two intervention groups, in terms of non-inferiority: a) an e-mental health care group (EMH-care) and b) an occupational physician care group (OP-care). A pre-randomisation procedure with incomplete-double-consent design was applied, meaning that individuals were only informed about their own group. 14 Outcome measures were obtained from all participants at baseline (March 2011). Follow-up measures were obtained three and six months after baseline. The Medical Ethics Committee of the Academic Medical Center Amsterdam approved the study. All participants gave written informed consent before taking part. The design, conduct and reporting of this study adhere to the Consolidated Standards of Reporting Trials guidelines. 15,16 Participants The study population of the complete trial consisted of all nurses, including surgical nurses and anaesthetic nurses, and allied health professionals (such as physiotherapists and radiotherapists) working in one academic hospital in the Netherlands. Since it regarded a preventive study, participants were included if they were not, or were not expecting to be on sick leave for more than two weeks at baseline. 102

104 Effectiveness of a mental health module for WHS, comparing two approaches All eligible employees were invited to take part in the study, which for the complete trial added up to 1,731 employees working in 86 wards. The minimum required sample size was 718 participants for the complete trial. 13 After randomisation at ward level, 29 wards with 579 employees were assigned to the EMH-care group and 28 wards with 591 employees to the OP-care group. The remaining wards and employees were assigned to the control group, which will not be discussed in the present paper. Setting The academic hospital has its own in-company occupational health service. For each division, which contains several wards, an OP is responsible for the occupational health care. Employees who are sick-listed for more than two weeks are required (in accordance with the Dutch occupational healthcare system) to visit their OP for independent judgment of sick leave and for return-to-work guidance. Furthermore, all employees of the hospital can make use of the free accessible consulting hour for questions about work and health. According to the in-company occupational health service, usage of the free accessible consultations by employees is limited. Procedure In March 2011, an invitation was sent by to fill out the baseline questionnaire online, which could be filled out at any time during six weeks. It was possible to discontinue the questionnaire and complete it after logging in again. Three reminders were sent, as well as an information letter to their home address. Those who had completed the baseline questionnaire were invited to fill out the follow-up questionnaires three and six months after baseline. 5 Interventions Screening and personalised feedback At baseline, participants in both groups were screened on the following aspects (for details see Gärtner et al. 13 ): impaired work functioning, distress, work-related fatigue, alcohol use, depression including suicide risk, anxiety, panic disorder and posttraumatic stress. The work relatedness of any mental health complaint was also assessed. Participants received personalised feedback on their screening results immediately after filling out the baseline questionnaire, both onscreen and in an . E-mental health care For participants in the EMH-care group, the personalised feedback was followed by an invitation for a tailored choice of self-help e-mental health interventions, based on an algorithm (Appendix 1). Participants were mostly offered a choice of two or three e-mental health interventions, to leave room for personal preferences. Participants who screened negative on all mental health complaints were invited to follow an e-mental health intervention aimed at enhancing and retaining their mental fitness. 103

105 CHAPTER 5 The Internet-based self-help e-mental health interventions aim to reduce specific mental health complaints or enhance well-being and were developed by the Trimbos Institute (Netherlands Institute of Mental Health and Addiction) at an earlier stage. They are mainly based on the principles of cognitive behavioural therapy and combine a variety of aspects, e.g., providing information and advice, weekly assignments, the option of keeping a diary and a forum to get in contact with others with similar complaints. The e-mental health interventions used in the study were as follows: Psyfit: 17 aimed at enhancing mental fitness, also offered to healthy participants. Strong at work (Dutch: Sterk op je Werk): 18 aimed at gaining insight into work stress and learning skills to cope with work stress. Colour your life: 19 aimed at tackling depressive symptoms. Don t Panic Online: 20 aimed at reducing panic symptoms for subclinical and mild cases of panic disorder. Drinking less: 10 aimed at reducing risky drinking behaviour. In case of positive screening on impaired work functioning (regardless of their mental health state), participants received an onscreen educational leaflet on how to improve their work functioning. Occupational physician care For participants in the OP-care group who screened positive on impaired work functioning and/or on any mental health complaints, the personalised feedback was followed by an invitation for a face-to-face preventive consultation with their own occupational physician (OP), within two weeks. They were sent a letter to their home address with an appointment for this consultation. The consultation was voluntary and supervisors were not informed about it. A consultation protocol was developed 21 which was based on interviews with the participating OPs to elicit their current practice and on the evidence-based guideline for OPs treatment of employees with mental health problems. 22 It consisted of seven steps: 1) discussing expectations; 2) discussing screening results and characteristics of work functioning and mental health complaints; 3) discussing possible causes in the private, work, and health condition and consequences for work functioning; 4) identifying the problem and offering rationale; 5) giving advice on how to tackle health complaints, how to improve work functioning, how to prevent consequences of impaired work functioning, and how to communicate with the supervisor about work functioning and mental health; 6) discussing possible follow-up or referral to other care providers; and 7) summarising the consultation. All participating OPs received three-hour training in using the protocol. 104

106 Effectiveness of a mental health module for WHS, comparing two approaches Measures All outcomes were measured at baseline and at 3- and 6-months follow-up. Primary outcome The primary outcome of this study was impaired work functioning, measured using the total score of the Nurses Work Functioning Questionnaire (NWFQ). 4 In the screening phase, all seven of the original subscales were used. Participants scored green, orange or red on each subscale. A red score on one or more subscales and/or three or more orange scores led to case identification of impaired work functioning. 13 Only six of the seven original NWFQ subscales were used for the outcome measure, other than how it was described in the trial s design study, 13 because the reproducibility of the impaired decision-making subscale was found to be poor. 23 The total score on the NWFQ was calculated with the 47 items of the remaining six subscales, with a total score range of 0-100, a higher score indicating more severely impaired work functioning. The difference between the two study groups regarding impaired work functioning was examined in two ways: as a continuous outcome and as the percentage of individuals who had improved relevantly at follow-up. 24 Secondary outcomes The secondary outcomes included distress, work-related fatigue, posttraumatic stress, and work ability. 5 Distress was measured with the distress subscale of the Four-Dimensional Symptoms Questionnaire (4DSQ). 25,26 The 16-item questionnaire uses a 5-point response scale (0 = no, 4 = very often) and has a total score range of 0-32, a higher score indicating a higher level of distress [cut-off point ]. Work-related fatigue after working time was measured using the need for recovery subscale of the Dutch Questionnaire on the Experience and Evaluation of Work (QEEW). 28 The 11-item questionnaire with dichotomous response categories (yes, no) has a total score range of 0-11 and a standardised score range of 0-100, a higher score indicating a higher level of work-related fatigue [cut-off point ]. Posttraumatic stress was measured with the Dutch version of the Impact of Event Scale. 30,31 The 15-item questionnaire uses a 4-point response scale (0 = not at all, 3 = often). Total scores range from 0 to 75, with higher scores indicating a higher level of posttraumatic stress [cut-off point ]. 105

107 CHAPTER 5 Work ability was assessed with the first item of the Work Ability Index (WAI), 33 concerning the evaluation of current work ability compared to their lifetime best on an 11 point scale (0 = completely unable to work, 10 = work ability at its best), a higher score indicating a higher level of work ability. Other secondary outcomes that were mentioned in the study protocol 13 will be presented elsewhere. Statistical analyses All participants who completed the baseline questionnaire and who screened positive on impaired work functioning and/or impaired mental health were analysed, as the work functioning and work-related mental health of these participants could be expected to change due to the interventions. However, since this was not pre-specified in the trial registration, the analyses were also performed for the total sample. The analyses were performed at the level of the individual employee, according to the intention-to-treat principle. Dropout analysis A dropout analysis was performed to detect whether dropping out (not completing trial participation) was related to the primary outcome impaired work functioning and to identify potential predictive variables of dropout. Dropping out of the trial was defined as completing the baseline and 3-month follow-up questionnaires, but not the 6-month follow-up questionnaire; or completing the baseline questionnaire, but none of the follow-up questionnaires. Differences between non-dropouts and dropouts in impaired work functioning over time in both separate groups were explored in graphs. If different patterns of the effect were detected, a Mann-Whitney U test was performed to test the significance of the differences. In the event of statistically significant differences, a multiple logistic regression analysis was performed with dropout as the dependent variable, to identify potential predictive variables for dropout. Screening positive on mental health complaints (yes/no) and age were included as the independent variables, as we expected that these two aspects might be related to dropping out of the trial. If the multiple logistic regression analysis showed one or both of these aspects to have a statistically significant effect on dropout, they were included as a covariate in the effect analyses. 34 Effect analysis To analyse the differences over time between the groups on each outcome, Linear mixed models (LMM) were applied. If the assumption of a normal distribution of residuals was not met, a log-transformation was used for the LMM and the median and range were 106

108 Effectiveness of a mental health module for WHS, comparing two approaches used to describe the outcome. Otherwise, the mean and standard deviation were used to describe the outcome. For each outcome, the scores at 3- and 6-months follow-up were included as dependent variables in the LMM, while the baseline score was included as a covariate. The main effects of group and time of measurement and the interaction of group x time of measurement were included as fixed effects in the model. Ward (the cluster level) and subject (the individual level) were included as random effects; however, if the cluster level did not have a statistically significant effect, it was considered negligible and was, therefore, omitted from the model. The effects of interest were the main effect of group and the interaction effect of group x time of measurement. Furthermore, the relative change scores of individuals on impaired work functioning after three and after six months of follow-up compared to their baseline score were calculated. Individuals with a relative improvement on their NWFQ total score of 40% or more, which is the minimal important change (MIC) value of the NWFQ total scale, 24 were defined as relevantly improved. The percentages of individuals who had improved relevantly in each group were compared using a Fisher s exact test, for both 3- and 6-months follow-up. To test for non-inferiority, the mean of the absolute improvement on work functioning (using the NWFQ total score) of positively screened participants was calculated for both groups, defined as the improvement between baseline and follow-up. The difference between the means of both groups was tested with an unpaired samples t test (two-sided). If the confidence interval around this difference did not exceed our non-inferiority margin that was the minimal important change value for absolute improvements of = -10 points, 24 meaning that an advantage of the OP-care group over the EMH-care group was not larger than 10 points, we regarded the EMH-care group to be non-inferior to the OP-care group. 5 The significance level was set at α = All analyses were carried out using the statistical package IBM SPSS Statistics 19. RESULTS Participant flow and compliance The flow of participants and their compliance to the intervention are shown in Figure 1. From March 15 th until April 26 th, 422 employees were enroled in the study. A total of 369 participants (32%) were eligible for participation in the study, 178 in the EMH-care group and 191 in the OP-care group. Of the participants in the EMH-care group, 80 were lost to follow-up, compared to 49 in the OP-care group. The reasons for withdrawal from the 107

109 CHAPTER 5 Randomisation of wards 57 wards 1,170 individuals 29 wards in EMH-care intervention group 579 individuals approached for participation in EMH-care group 28 wards in OP-care intervention group 591 individuals approached for participation in OP-care group 212 started baseline questionnaire including screening 210 started baseline questionnaire including screening 29 did not complete baseline questionnaire 5 sicklisted > 2 weeks 16 did not complete baseline questionnaire 3 sicklisted > 2 weeks 178 completed baseline questionnaire 191 completed baseline questionnaire 139 screened positive for impaired work functioning and/or impaired mental health 39 screened negative for impaired work functioning and/or impaired mental health 151 screened positive for impaired work functioning and/or impaired mental health 40 screened negative for impaired work functioning and/or impaired mental health 108

110 Effectiveness of a mental health module for WHS, comparing two approaches Preventive consultation: 51 visited OP 74 cancelled/no-show 26 no appointment made due to system error E-mental health intervention: 28 logged into an intervention 80 were lost to follow-up 49 were lost to follow-up 142 were analysed as the total sample, of which 108 were analysed as the positively screened sample 98 were analysed as the total sample, of which 75 were analysed as the positively screened sample Figure 1 Flow of participants through the trial

111 CHAPTER 5 study were not assessed. Fifty-six of the participants in the EMH-care group had completed all three online questionnaires after six months, versus 99 participants in the OP-care group. Analyses for the primary and secondary outcomes were performed on participants who screened positive (EMH N = 75; OP N = 108) and on all participants (EMH N = 98; OP N = 142). Study population at baseline The baseline characteristics of the study population are shown in Table 1. The participants in both groups were fairly similar. Only age differed somewhat, participants in the EMH-care being younger than those in the OP-care group. Most of the participants were nurses, most were female and most had a permanent position in the hospital. In both groups, almost 80% screened positive on impaired work functioning and/or impaired mental health at baseline. Dropout analysis Differences between non-dropouts and dropouts in impaired work functioning over time were explored in graphs. These graphs showed that in the EMH-care group, dropouts had a worse score on impaired work functioning than non-dropouts at baseline and 3-months follow-up. A Mann-Whitney U test identified these differences to be significant in the EMH-care group (baseline p = 0.01; 3-months follow-up p = 0.04) and in the total group (baseline p = 0.01; 3-months follow-up p = 0.03). In a subsequent multiple logistic regression analysis, mental health complaints (yes/no) and age did not significantly predict dropout in the entire group (p = 0.06 and p = 0.07, respectively). Therefore, they were not included as covariates in the effect analyses. Intervention effects In Table 2, the results of the LMM analyses are shown. The random effect of ward was not statistically significant in any of the analyses, and therefore, ward as the cluster level was excluded from the model in the analyses. Impaired work functioning (primary outcome) Both the EMH-care group and the OP-care group improved over time regarding impaired work functioning, with the largest improvement between baseline and 3-months follow-up. In the LMM analysis in the positively screened sample, no significant difference in impaired work functioning between the EMH-care group and the OP-care group was identified (main effect of group p = 0.12; interaction effect group x time p = 0.45). In the total sample (thus including participants who did not screen positive on impaired work functioning and/or impaired mental health at baseline), no statistically significant difference between the two groups was found either (main effect of group p = 0.33; interaction effect group x time p = 0.13) (data not shown in table). 110

112 Effectiveness of a mental health module for WHS, comparing two approaches Table 1 Baseline characteristics of participants in the EMH-care group and the OP-care group. TOTAL SAMPLE EMH-care (N = 178) OP-care (N = 191) POSITIVELY SCREENED SAMPLE EMH-care (N = 139) OP-care (N = 151) Variable n (%) n (%) n (%) n (%) Gender Female 147 (83) 156 (82) 113 (81) 124 (82) Age in years [mean (SD)] 37 (12) 43 (11) 38 (12) 43 (11) Occupation Nurse 129 (73) 116 (61) 99 (71) 89 (59) Nurse practitioner 11 (6) 12 (6) 7 (5) 9 (6) Surgical nurse 0 (0) 12 (6) 0 (0) 12 (8) Anaesthetic nurse 0 (0) 12 (6) 0 (0) 9 (6) Allied health professional 38 (21) 39 (20) 33 (24) 32 (21) Nursing specialization Yes 74 (57) 77 (66) 57 (58) 58 (65) Years of experience [mean (SD)] 10 (10) 12 (11) 11 (10) 13 (10) Working hours per week according to contract [mean (SD)] Type of contract 31 (5) 29 (8) 31 (5) 29 (7) Permanent position 160 (91) 172 (92) 125 (91) 136 (92) Fixed-term contract 13 (7) 9 (5) 11 (8) 7 (5) Temporary employment 0 (0) 6 (3) 0 (0) 4 (3) Other 3 (2) 1 (1) 1 (1) 1 (1) Impaired work functioning a (above cut-off ) Work functioning impairments 107 (60) 115 (60) 107 (77) 115 (76) Impaired mental health (above cut-off ) Impaired mental health (above cut-off of one or more of the six mental health aspects) 109 (61) 112 (59) 109 (78) 112 (74) Distress 41 (23) 50 (26) 41 (30) 50 (33) Work-related fatigue 61 (34) 52 (27) 61 (44) 52 (34) Posttraumatic stress 24 (14) 21 (11) 24 (17) 21 (14) Screened positive on impaired work functioning and/or impaired mental health 139 (78) 151 (79) 139 (100) 151 (100) 5 a Impaired work functioning is presented here including the subscale impaired decision making, as it was included in the baseline screening. 111

113 CHAPTER 5 Table 2 Descriptives of the positively screened sample on primary and secondary outcomes at baseline and 3- and 6-months follow-up, with p values of LMM analyses. Relative frequency above cut-off (%) E-mental health care (n = 75) Median (range) Mean (SD) Occupational physician care (n = 108) Relative frequency above cut-off (%) Median (range) Mean (SD) p value (LMM analyses) Group Group X time Primary outcome Impaired work functioning (NWFQ 0-100) a b 91/139 (66) 14 (0-56) 88/151 (58) 12 (0-51) mn 33/62 (53) 10 (0-39) 38/100 (38) 9 (0-38) 6 mn 19/52 (37) 8 (0-41) 34/86 (40) 8 (0-62) Secondary outcomes Distress (4DSQ, 0-32) b 41/139 (30) 7 (0-32) 50/151 (33) 6 (0-30) mn 9/61 (15) 4 (0-29) 17/99 (17) 4 (0-28) 6 mn 10/52 (19) 5 (0-29) 14/86 (16) 5 (0-31) Work-related fatigue (QEEW, 0-100) b 61/139 (44) 44 (28) 52/151 (34) 36 (29) mn 22/61 (36) 36 (31) 30/98 (31) 31 (28) 6 mn 14/52 (27) 34 (30) 28/85 (33) 33 (28) Posttraumatic stress (IES, 0-75) b 24/139 (17) 3 (0-71) 21/151 (14) 2 (0-75) mn 10/61 (16) 1 (0-48) 7/97 (7) 0 (0-47) 6 mn 5/51 (10) 0 (0-31) 7/85 (8) 0 (0-65) Work ability (WAI, 0-10) b 7 (1) 8 (1) mn 8 (1) 8 (1) 6 mn 8 (2) 8 (2) a NWFQ total scores are calculated without the subscale impaired decision making. b, baseline; 3 mn, follow-up after 3 months; 6 mn, follow-up after 6 months. 112

114 Effectiveness of a mental health module for WHS, comparing two approaches The mean absolute change score on impaired work functioning between baseline and 3-months follow-up was an improvement of 1.87 for the EMH-care group and an improvement of 3.82 for the OP-care group, identifying a disadvantage of the EMH-care group of (95% CI to 0.28, p = 0.09). Between baseline and 6-months follow-up, the EMH-care group had improved with 1.54 and the OP-care group with 2.94, a disadvantage of the EMH-care group of (95% CI to 1.39, p = 0.32). For each follow-up, the lower limit of the confidence interval does not exceed -10, indicating non-inferiority of the EMH-care group. In Figure 2, the percentages of participants whose work functioning had improved relevantly after three and six months compared to their baseline score are presented. In the positively screened sample, the work functioning of 46% of the participants in the OP-care group had improved relevantly after three months. Thirty per cent of participants in the EMH-care group had improved relevantly after three months. The difference between the groups was not statistically significant (p = 0.07). After six months, 41% of participants in the OP-care group and 36% of participants in the EMH-care group had improved relevantly regarding work functioning compared to baseline (p = 0.59). Significantly improved in work functioning (%) mn 6 mn EMH-care OP-care 5 Time Figure 2 Percentage of participants in the positively screened sample who had improved with at least the minimal important change on their work functioning, at 3- and 6-months follow-up. 113

115 CHAPTER 5 In the total sample (data not shown in figure), the difference after three months was slightly smaller (OP-care group 42%; EMH-care group 30%; p = 0.11). After six months, in both groups, 40% of the participants had improved relevantly compared to baseline (p = 1.00). Secondary outcomes As shown in Table 2, no significant differences were found between the EMH-care group and the OP-care group on distress, work-related fatigue, posttraumatic stress and work ability in the positively screened sample (0.06 p 0.99). The patterns in both groups were very similar. Regarding distress, work-related fatigue and posttraumatic stress, both groups improved over time. In all cases, the largest improvement was between baseline and 3-months follow-up. Between 3- and 6-months follow-up, a smaller improvement was detected and in some cases even a slight deterioration. Regarding work ability, the OP-care group scored slightly better than the EMH-care group at baseline but did not improve over time, while at 3-months follow-up, the EMH-care group had improved to the level of the OP-care group and also did not improve any further. When examining the entire sample of participants, the LMM analyses showed results similar to those in the positively screened sample, as again no significant differences between the groups were identified (0.28 p 0.86) (data not shown in table). DISCUSSION One-third of the invited employees participated in the study at baseline. Almost 80% screened positive for impaired work functioning and/or impaired mental health. Both groups improved over time regarding impaired work functioning, and a considerable percentage of participants in both groups improved relevantly regarding work functioning. Regarding distress, work-related fatigue and posttraumatic stress, both groups also improved over time. No statistically significant differences were found between the effects of the EMH approach and the OP approach for a mental module for WHS on impaired work functioning, distress, work-related fatigue, posttraumatic stress and work ability. Differences between the two approaches did not exceed the pre-defined criterion of >10 points on work functioning, indicating non-inferiority of the EMH approach compared to the OP approach. However, the OP-care group trended towards better performance. In our study, we endeavoured to improve work functioning of nurses and allied health professionals through screening on impaired work functioning and impaired mental health, followed by personalised feedback and a tailored intervention. We consider this to be an important approach, as ultimately the goal of occupational healthcare is to keep employees functioning well, as healthy as possible. 114

116 Effectiveness of a mental health module for WHS, comparing two approaches The response rate at baseline in this study is similar to other studies in which employees were screened on mental health complaints or on general health risks. 38 We do not have data on reasons for non-responding, but some of the reasons for not participating in this study that we heard from supervisors and eligible participants were as follows: feeling overloaded with research, because the employees of the academic hospital are asked to take part in many other research projects; fear of privacy violation, although anonymity of their enrolment was stressed; and the extensive questionnaire that took at least 30 min. to fill out. Our hypothesis stated that an EMH approach would be non-inferior to an OP approach in its effect on work functioning and several mental health outcomes. We did indeed find no significant differences in their effects on impaired work functioning, distress, work-related fatigue, posttraumatic stress and work ability over time between the EMH-care group and the OP-care group, and further analysis suggested non-inferiority. Since the OP approach was successful in improving work functioning compared to a control group, 8 these findings are promising for the EMH approach. When looking closer at trends regarding impaired work functioning, the following can be detected. Both groups improved over time on impaired work functioning, and we found no significant difference between the groups. In the OP-care group, a larger percentage of participants improved relevantly regarding work functioning than in the EMH-care group (non-significant). Thus, the OP-care group trended towards a better performance than the EMH-care group regarding the improvement of work functioning. 5 Both approaches for a mental module for WHS consisted of two parts: 1) online screening on impaired work functioning and mental health, followed by personalised feedback; and 2) either a preventive consultation with an OP or a tailored choice of self-help e-mental health interventions. All positively screened participants received part one of the intervention, but not everyone complied to part two of the intervention. Compliance to the offered e-mental health interventions was low, as only nine positively screened participants in the EMH-care group started an e-mental health intervention at least to some extent. The number of elements followed by those who did start on an e-mental health intervention varied, but no one completed all elements. 39 Compliance in the OP-care group was considerably higher (34%), offering a possible explanation for its better performance. In most of the consultations, all steps of the protocol were followed. In 61% of consultations, an advice was given to the employee, and ten employees were referred to other healthcare providers. 39 Since results on work functioning and work-related mental health were promising in both groups, screening plus personalised feedback without further interventions might already bring about a positive effect. 115

117 CHAPTER 5 The process evaluation also gave us some insight into the possible reasons for non-use of the second, approach-specific part of the intervention. 39 In the OP-care group, the most mentioned reason for not going to the preventive consultation was that they did not find it necessary. Most of those who did go found the advice that was given by the OP useful, and nine out of 15 participants indicated that following the OPs advice helped improve their mental health and/or work functioning. Very few participants in the EMH group graded the EMH intervention they followed, and the grades they gave varied greatly. These few participants further indicated that following the EMH intervention(s) did not help to improve their mental health or work functioning. Unfortunately, participants in the EMH-care group, when asked, offered no explanation why they did not follow an e-mental health intervention. Self-help EMH interventions often have low compliance rates. 40 However, we think that several reasons could underlie the low compliance to these interventions. First of all, our study regarded a preventive setting, and the perceived need of the participants may have been insufficient to motivate them to log into and follow an e-mental health intervention. Other studies have shown that being identified as having mental health complaints does not automatically mean that you experience a problem yourself 41 or that you perceive a need of mental healthcare. 42 Secondly, some of the participants reported problems with logging into the interventions, due to technical problems and/or inadequate computer skills, which might have posed a problem for more participants. Lastly, e-mental health interventions may be too impersonal for nurses and allied health professionals, since they have chosen a people-oriented and face-to-face occupation themselves. To gain more insight into whether screening and feedback only was effective in its own regard, we performed a post hoc analysis by calculating an effect size (Cohen s d 43 ) for the screening and feedback only group and the group who followed up on the additional intervention. This was only possible for the OP-care group, since so few people (partly) followed an EMH intervention. We found that when looking at the first follow-up after three months, going to the preventive consultation resulted in a larger effect (d = 0.50, medium sized effect) than screening and feedback alone (d = 0.34, small effect). When examining the second follow-up after six months, the effect sizes of screening and feedback alone, and additionally going to a preventive consultation were similar (d = 0.35 and d = 0.24, respectively, small effects). Possibly, the effect of one preventive consultation is short-lived and needs to be enhanced by offering more advice or follow-up. However, it should be kept in mind that the group of participants who came to the preventive consultation is based on self-selection. They might differ from the screening and feedback only group in some way, complicating the comparison between these two groups. 116

118 Effectiveness of a mental health module for WHS, comparing two approaches An important strength of this study was the cluster-randomisation design that was carried out at ward level. This made it possible to prevent contamination between the study groups as much as possible. Furthermore, a pre-randomisation procedure with incomplete-double-consent principle was applied, meaning that individuals were only informed about their own group. This further minimized the possibility of contamination. Another asset of our study was our relevant choice of margin to determine non-inferiority. The smallest value that would be a clinically important effect is often chosen as margin. 44 We applied the minimal important change (MIC) for absolute improvement on work functioning which was recently determined for the instrument that we used, the Nurses Work Functioning Questionnaire. 24 We used the MIC for a high baseline group in our sample who screened positive on impaired work functioning and/or impaired mental health. One limitation of our study was that we did not meet our required sample size for sufficient power, which was set at 189 participants in each group who completed participation. This increases the chance of finding non-significant p values despite trends for differences. Secondly, we did not perform per-protocol analyses that are more robust in case of testing for non-inferiority, 45 because the sample size of participants who complied to the complete offered intervention was too low. We can, therefore, not clearly distinguish between the unspecific effect of screening and feedback and the specific effect that is attributable to either the OP approach or the EMH approach. 5 A third limitation was the fairly high dropout rate of participants, especially in the EMH-care group. This loss to follow-up was selective, as dropouts in the EMH-care group had higher scores on impaired work functioning at baseline and 3-months follow-up than the participants who did not drop out of the trial. This may have introduced bias, although in which direction is unclear. As impaired work functioning and impaired mental health were highly prevalent in the population that was studied, it seems wise to focus on preventive actions. The WHS mental module was well received by the nurses and allied health professionals who did participate in the study. 39 Insight is needed into which type of employees take part in WHS and comply to the offered interventions, and who do not. Possibly the strategy of online screening, online personalised feedback and a subsequent intervention did not appeal to the employees who did not participate and the participants who dropped out of the study. However, the extensive questionnaires due to it being a research project might have played a part in this. Additionally, the e-mental health 117

119 CHAPTER 5 interventions were started and partly followed by very few participants. A strategy for a mental module for workers health surveillance should be sought that fits with the target population s preferences. To improve compliance to the e-mental health interventions, it could be useful to apply elements of persuasive design, i.e., to increase motivation and ability to follow an e-mental health intervention and to incorporate triggers to encourage participation and compliance. 46 Furthermore, it might be effective to combine e-mental health interventions with face-to-face contact with a healthcare provider (blended care), as in the OP-care group, a larger percentage of participants complied to the intervention and improved on work functioning. 118

120 Effectiveness of a mental health module for WHS, comparing two approaches REFERENCES 1 Hämmig O, Brauchli R, Bauer G. Effort-reward and work-life imbalance, general stress and burnout among employees of a large public hospital in Switzerland. Swiss Med Wkly 2012; Letvak S, Ruhm CJ, McCoy T. Depression in hospital-employed nurses. Clin Nurse Spec 2012; 26: Letvak SA, Ruhm CJ, Gupta SN. Nurses presenteeism and its effects on self-reported quality of care and costs. Am J Nurs 2012; 112: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: Koh D & Aw TC. Surveillance in occupational health. Occup Environ Med 2003; 60: Sluiter JK. High-demand jobs: age-related diversity in work ability? Appl Ergon 2006; 37: NVAB [Netherlands Society of Occupational Medicine]. Guidance Workers Health Surveillance [in Dutch: Leidraad Preventief Medisch Onderzoek]. Utrecht, the Netherlands: NVAB, Gärtner FR, Nieuwenhuijsen K, Ketelaar SM et al. The Mental Work study: effectiveness of a mental module for workers health surveillance for nurses and allied health care professionals on their help-seeking behavior. J Occup Environ Med 2013; 55: Billings DW, Cook RF, Hendrickson A, Dove DC. A web-based approach to managing stress and mood disorders in the workforce. J Occup Environ Med 2008; 50: Riper H, Kramer J, Smit F et al. Web-based self-help for problem drinkers: a pragmatic randomized trial. Addiction 2008; 103: Warmerdam L, van Straten A, Twisk J et al. Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res 2008; 10:e Spek V, Nyklicek I, Smits N et al. Internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years old: a randomized controlled clinical trial. Psychol Med 2007; 37: Gärtner FR, Ketelaar SM, Smeets O et al. The Mental Work study: design of a randomized controlled trial on the effect of a workers health surveillance mental module for nurses and allied health professionals. BMC Public Health 2011; 11: Schellings R, Kessels AG, ter Riet G et al. Indications and requirements for the use of prerandomization. J Clin Epidemiol 2009; 62: Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328: Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010; 1: Bolier L, Haverman M, Kramer J et al. Internet-based intervention to promote mental fitness in mildly depressed adults: design of a randomized controlled trial. JMIR Res Protoc 2012; 1:e2. 18 RIVM Centrum Gezond Leven. Course Strong at Work [in Dutch: Cursus Sterk op het werk ], Accessed 16 January de Graaf LE, Gerhards SA, Arntz A et al. Clinical effectiveness of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial. Br J Psychiatry 2009; 195: van Ballegooijen W, Riper H, van Straten A et al. The effects of an Internet based self-help course for reducing panic symptoms - Don t Panic Online: study protocol for a randomised controlled trial. Trials 2011; 12: Gärtner FR. Work functioning impairments due to common mental disorders. Measurement and prevention in nurses and allied health professionals (Doctoral Dissertation). Amsterdam, the Netherlands: University of Amsterdam, van der Klink JJ. Guideline: Management of mental health problems of workers by occupational physicians [in Dutch: Richtlijn: Handelen van de bedrijfsarts bij werkenden met psychisch problemen]. Utrecht, the Netherlands: NVAB [Netherlands Society of Occupational Medicine], Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Psychometric properties of the Nurses Work Functioning Questionnaire (NWFQ). PLoS One 2011; 6:e

121 CHAPTER 5 24 Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Interpretability of change in the Nurses Work Functioning Questionnaire: minimal important change and smallest detectable change. J Clin Epidemiol 2012; 65: Terluin B. The Four Dimensional Symptom Questionnaire (4DSQ) [in Dutch: De Vierdimensionele Klachtenlijst (4DKL) in de huisartspraktijk]. De Psycholoog 1998; 33: Terluin B, van Marwijk HW, Ader HJ et al. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry 2006; 6: van Rhenen W, van Dijk FJ, Schaufeli WB, Blonk RW. Distress or no distress, that s the question: A cutoff point for distress in a working population. J Occup Med Toxicol 2008; 3:3. 28 van Veldhoven M & Meijman T. The measurement of psychosocial job demands with a questionnaire: the questionnaire on the experience and evaluation of work (QEEW) [in Dutch: Het meten van een psychosociale arbeidsbelasting met een vragenlijst: de vragenlijst beleving en beoordeling van arbeid (VBBA)]. Amsterdam, the Netherlands: Dutch Institute for Working Conditions, Broersen JPJ, Fortuin RJ, Dijkstra L et al. Monitor occupational health and safety: key indicators and limits [in Dutch: Monitor Arboconvenanten: kengetallen en grenswaarden]. TBV 2004; 12: Brom D & Kleber RJ. The Impact of Event Scale [in Dutch: De Schok Verwerkings Lijst]. Nederlands Tijdschrift voor de Psychologie 1985; 40: Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med 1979; 41: van der Ploeg E & Kleber RJ. Acute and chronic job stressors among ambulance personnel: predictors of health symptoms. Occup Environ Med 2003; 60:i40-i Tuomi K, Ilmarinen J, Jahkola A et al. Work Ability Index. Helsinki, Finland: Finnish Institute of Occupational Health, DeSouza CM, Legedza AT, Sankoh AJ. An overview of practical approaches for handling missing data in clinical trials. J Biopharm Stat 2009; 19: Harvey SB, Glozier N, Henderson M et al. Depression and work performance: an ecological study using web-based screening. Occup Med (Lond) 2011; 61: Lexis MA, Jansen NW, Huibers MJ et al. Prevention of long-term sickness absence and major depression in high-risk employees: a randomised controlled trial. Occup Environ Med 2011; 68: Wang PS, Simon GE, Avorn J et al. Telephone Screening, Outreach, and Care Management for Depressed Workers and Impact on Clinical and Work Productivity Outcomes. JAMA 2007; 298: Colkesen EB, Kraaijenhagen RA, Frings-Dresen MH et al. Participation in a workplace web-based health risk assessment program. Occup Med (Lond) 2011; 61: Ketelaar SM, Gärtner FR, Bolier L et al. Mental Work - A Workers Health Surveillance mental module for nurses and allied health care professionals: Process evaluation of a randomized controlled trial. J Occup Environ Med 2013; 55: Eysenbach G. The law of attrition. J Med Internet Res 2005; 7:e Lexis MA, Jansen NW, Stevens FC et al. Experience of health complaints and help seeking behavior in employees screened for depressive complaints and risk of future sickness absence. J Occup Rehabil 2010; 20: Codony M, Alonso J, Almansa J et al. Perceived need for mental health care and service use among adults in Western Europe: results of the ESEMeD project. Psychiatr Serv 2009; 60: Cohen J. Statistical power analysis for the behavioral sciences. 2nd edn. Hillsdale, N.J.: Lawrence Erlbaum Associates, Wiens BL. Choosing an equivalence limit for noninferiority or equivalence studies. Control Clin Trials 2002; 23: Piaggio G, Elbourne DR, Altman DG et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295: Fogg BJ. A Behavior Model for Persuasive Design, Accessed 16 January

122 Effectiveness of a mental health module for WHS, comparing two approaches APPENDIX 1 Algorithm for determining the specific choice of e-mental health interventions. a. Decision rules If the participant screens positive on anxiety, he or she is screened on panic disorder. If the participant screens positive on suicide risk, the participant is advised to seek contact with their general physician. They can also indicate that they prefer to receive an invitation for an appointment with their occupational physician. A link to the national online suicide prevention platform (113 Online) is provided, where they can seek help anonymously. No advice on how to improve their work functioning (if applicable) is given and no e-mental health interventions are offered, as we regard it most important to seek help for the suicidal thoughts. The offered choice of e-mental health interventions is as specific as possible for the (combination of) mental health complaint(s). Freedom of choice of the participant is an important aspect. Therefore, if possible, different options are given so that the participant can choose. When necessary, a priority is given by means of recommended or optional. As we do not dispose of a specific e-mental health intervention directed towards anxiety (other than panic), if the participant screens positive on only anxiety and no panic the advice is given to seek contact with the occupational physician if the complaints persist. The e-mental health intervention Strong at Work is not offered as an option if the mental health complaints are not related to work. If the participant screens positive on distress and/or work-related fatigue and more severe mental health problems, the offered choice is only directed towards the more severe mental health problems. If the participant screens positive on two or more mental health complaints (more severe than distress and/or work-related fatigue), the e-mental health intervention Psyfit is no longer given as an option because we prefer someone to follow a stronger intervention. If the participant screens positive on two or more mental health complaints (more severe than distress and/or work-related fatigue) for which we can offer a specific e-mental health intervention (i.e. depression, panic and risky drinking behaviour), the advice is given to prioritise according to their own suffering (i.e. what do they feel they suffer from the most?). If the participant screens positive on three or more mental health complaints (more severe than distress and/or work-related fatigue), the advice is given to also seek contact with the occupational physician

123 CHAPTER 5 b. Schematic representation of the algorithm Questionnaire screening: * problems in work functioning (WF) * mental health problems (MH) * work relatedness of mental health complaints (WR): participant has WF problems and/or his or her MH problems are caused by work Intervention Suicide risk? YES Advice GP/OP + link to national online suicide prevention platform NO WF? YES Advice on how to improve work functioning NO MH? NO E-mental health intervention: Psyfit YES Check specific (combination of) complaint(s) WR? Tailored offer of intervention(s) 122

124 Effectiveness of a mental health module for WHS, comparing two approaches c. Example of specific algorithm for participants who screen positive for depression Work related? YES Choose 1 based on preference: Colour your life (recommended) Strong at Work (optional) Psyfit (optional) NO Choose 1 based on preference: Colour your life (recommended) Psyfit (optional) 5 123

125

126 6 EFFECT OF AN E-MENTAL HEALTH APPROACH TO WORKERS HEALTH SURVEILLANCE VERSUS CONTROL GROUP ON WORK FUNCTIONING OF HOSPITAL EMPLOYEES: A CLUSTER-RCT Sarah M. Ketelaar Karen Nieuwenhuijsen Fania R. Gärtner Linda Bolier Odile Smeets Judith K. Sluiter PLoS ONE 2013; 8:e72546.

127 CHAPTER 6 ABSTRACT Objective: To evaluate an e-mental health (EMH) approach to workers health surveillance (WHS) targeting work functioning (WF) and mental health (MH) of healthcare professionals in a randomised controlled trial. Methods: Nurses and allied health professionals (N = 1140) were cluster-randomised at ward level to the intervention (IG) or control group (CG). The intervention consisted of two parts: (a) online screening and personalised feedback on impaired WF and MH, followed by (b) a tailored offer of self-help EMH interventions. CG received none of these parts. Primary outcome was impaired WF (Nurses Work Functioning Questionnaire), assessed at baseline and after three and six months. Analyses were performed in the positively screened subgroup (i) and in all participants (ii). Results: Participation rate at baseline was 32% (N IG = 178; N CG = 188). Eighty-two percent screened positive for at least mild impairments in WF and/or MH (N IG = 139; N CG = 161). All IG-participants (N = 178) received part (a) of the intervention, nine participants (all positively screened, 6%) followed an EMH intervention to at least some extent. Regarding the subgroup of positively screened participants (i), both IG and CG improved over time regarding WF (non-significant between-group difference). After six months, 36% of positively screened IG-participants (18/50) had a relevant WF improvement compared to baseline, versus 28% (32/115) of positively screened CG-participants (non-significant difference). In the complete sample (ii), IG and CG improved over time but IG further improved between three and six months while CG did not (significant interaction effect). Conclusions: In our study with a full compliance rate of 6% and substantial drop-out leading to a small and underpowered sample, we could not demonstrate that an EMH-approach to WHS is more effective to improve WF and MH than a control group. The effect found in the complete sample of participants is not easily interpreted. Reported results may be useful for future meta-analytic work. 126

128 Effectiveness of an e-mental health approach to WHS INTRODUCTION Nurses have a high risk of developing common mental health complaints, such as distress, depression, and anxiety. 1-3 Impaired mental health of employees in healthcare occupations can have serious adverse effects, endangering the health and safety of not only themselves but also their patients. A study by Gärtner and colleagues found that impaired mental health in nurses and allied health professionals affects several aspects of their work functioning, including cognitive aspects (e.g. staying alert) and causing incidents at work. 4 Another study by Letvak and colleagues showed that depression in nurses was associated with presenteeism, which is in turn associated with patient falls, medication errors, and lower self-reported quality of care. 5 Adding to this, increased levels of psychological distress, even in a mild form, have been found to be associated with an increased likelihood of obtaining a disability pension in later life. 6 To sustain nurses and allied health professionals mental health and to enable them to remain healthy and well-functioning in their profession until retirement age, it is crucial to periodically screen these employees and provide interventions to improve their mental health and work functioning. A potentially promising method for the early detection of impaired mental health and subsequent treatment in nurses and allied health professionals, is offering a mental module for workers health surveillance (WHS). Although attention has been paid to the occupational hazards of healthcare employees, 7 WHS targeting work functioning and mental health of nurses and allied health professionals has, to our knowledge, not been reported before. WHS is an important component of occupational healthcare. 8 It is a means to implement preventive action by identifying and treating health complaints relevant to work, and it should be an essential component of programmes aimed at the protection of employees. 9 In the Netherlands, it has three aims: 1) to prevent the onset, recurrence, or worsening of work-related diseases, 2) to monitor and promote work-related health, and 3) to monitor and improve work functioning and employability. 10 It can be used to periodically monitor employees health and work functioning to detect impairments early and to bring timely interventions into action to prevent further impairment. It is recommended to apply a job-specific assessment, to allow for tailoring of interventions to the specific detected work functioning impairments as fitting as possible. 11 In this study, we detect early signs of impaired mental health and impaired work functioning in nurses and allied health professionals, and offer interventions using an e-mental health approach. 6 E-mental health (EMH) is the use of information and communication technology, and in particular the many technologies related to the Internet, to support and improve mental health. 12 Applying EMH might be a useful and feasible approach to perform a mental 127

129 CHAPTER 6 module for WHS. Online screening is a practical and efficient method to screen for self-reported impaired work functioning and impaired mental health. Furthermore, EMH offers possibilities regarding the subsequent interventions. Ritterband and colleagues defined Internet interventions as typically focused on behavioral issues, aiming to institute behavior change and subsequent symptom improvement, usually self-paced, interactive, and tailored to the user, and making use of the multimedia format offered by the Internet. 13 EMH interventions exist which target a wide variety of common mental disorders such as depression, anxiety, panic, phobias, and various addictions. Unguided self-help EMH interventions have been found to have positive outcomes for a variety of mental health aspects (e.g. Warmerdam et al., 14 Farrer et al., 15 Riper et al., 16 Blankers et al., 17 Billings et al. 18 ), although to our knowledge their effects on work functioning have not been studied in a specific working population such as nurses and allied health professionals. Moreover, EMH interventions have thus far only been offered as stand-alone interventions for a specific mental health complaint. In our study, we offer a choice of EMH interventions, tailored to the specific complaints as indicated by the individual s screening results. In this paper, we study the effect of an EMH-approach to WHS targeting work functioning and mental health of hospital-employed nurses and allied health professionals, on their work functioning, distress, work-related fatigue, posttraumatic stress, and work ability in a cluster-randomized controlled trial. We hypothesized that WHS, consisting of online screening on impaired work functioning and impaired mental health followed by personalised feedback and a tailored offer of self-help EMH interventions, will improve work functioning and mental health. METHODS The protocol for this trial (Chapter 3) and supporting CONSORT checklist are available as online supporting information. Ethics statement The Medical Ethics Committee of the Academic Medical Center Amsterdam approved this study (approved protocol available as online supporting information). All participants gave their written informed consent before taking part. Study design The study was designed as a cluster-randomised trial with block randomisation carried out at ward level. In order to guarantee allocation concealment, randomisation was performed by one researcher (KN) who was not involved in the practical recruitment of employees, using the computer software program Nquery Advisor with a block size of 128

130 Effectiveness of an e-mental health approach to WHS three. The complete trial included two intervention groups and one control group. 19 The present study compared one of the intervention groups, the e-mental health approach (EMH-approach) group, to the control group. The other intervention group consisted of an invitation for a preventive consultation with an occupational physician. A pre-randomisation procedure with incomplete-double-consent design was applied, 20 meaning that individuals were only informed about their own group. Outcome measures were obtained from all participants at baseline (March 2011) and follow-up measures were obtained three and six months after baseline. The design, conduct and reporting of this study adhere to the Consolidated Standards of Reporting Trials guidelines. 21,22 Details of the study design are reported elsewhere. 19 The trial registration number of the study is NTR2786 (Dutch Trial Register: trialregister.nl). Participants The study population of the complete trial was formed by all nurses, including surgical nurses and anaesthetic nurses, and allied health professionals (such as physiotherapists and radiotherapists) employed at one academic hospital in the Netherlands (N = 1,731). Nurses and allied health professionals form two large groups of hospital employees, and many of their work demands and work conditions are similar. Since it regarded a preventive study, participants were included if they were not, or were not expecting to be on sick leave for more than two weeks at baseline. All eligible employees were invited for participation in the study. To detect a clinically significant effect (effect size 0.33), while conducting the tests with alpha = 0.05 (two-tailed) and power = 0.80, and allowing for possible cluster effects and loss to-follow-up, the minimum required sample size was 718 participants for the complete trial. 19 After randomization at ward level (N = 86), 29 wards with 579 employees were assigned to the EMH-approach group and 29 wards with 561 employees to the control group (Figure 1). 6 Procedure In March 2011, potential participants received an invitation by to fill out the online baseline questionnaire which could be filled out at any time during six weeks. It was possible to discontinue the questionnaire and complete it after logging in again. Three reminders were sent, as well as an information letter to their home address. Those who had completed the baseline questionnaire were invited to fill out the follow-up questionnaires three and six months after baseline. 129

131 CHAPTER 6 Randomisation of wards 58 wards 1,140 individuals 29 wards in EMH-approach group 29 wards in control group 579 individuals approached for participation in EMH-approach group 561 individuals approached for participation in control group 212 started baseline questionnaire including screening 211 started baseline questionnaire 29 did not complete baseline questionnaire 5 sicklisted > 2 weeks 19 did not complete baseline questionnaire 4 sicklisted > 2 weeks 178 completed baseline questionnaire 188 completed baseline questionnaire 139 screened positive for impaired work functioning and/or impaired mental health 39 screened negative for impaired work functioning and/or impaired mental health 161 screened positive for impaired work functioning and/or impaired mental health 27 screened negative for impaired work functioning and/or impaired mental health 130

132 Effectiveness of an e-mental health approach to WHS 28 logged into an e-mental health intervention 80 were lost to follow-up 33 were lost to follow-up 155 were analysed as the total sample, of which 131 were analysed as the positively screened sample 98 were analysed as the total sample, of which 75 were analysed as the positively screened sample Figure 1 Flow of participants through the trial

133 CHAPTER 6 Intervention E-mental health approach group At baseline, participants in the EMH-approach group were screened on the following aspects (for details see Table 1 and Gärtner and colleagues 19 ): impaired work functioning, distress, work-related fatigue, risky drinking behaviour, depression including suicide risk, anxiety, panic disorder, and posttraumatic stress. Participants received personalised feedback on their screening results immediately after filling out the baseline questionnaire, both onscreen and in an . The personalised feedback was followed by an invitation for a tailored offer of self-help EMH interventions, on the basis of an algorithm based on the specific symptoms and the work-relatedness of the symptoms (see Appendix 1 in Chapter 5). Participants were mostly offered a choice of two or three EMH interventions to leave room for personal preferences. Participants who screened negative on all mental health complaints were invited to follow an EMH intervention aimed at enhancing and retaining their mental fitness. The EMH interventions used in this study are self-help interventions on the Internet aimed at reducing specific mental health complaints or enhancing wellbeing. The interventions are mainly based on the principles of cognitive behavioural therapy and combine a variety of aspects, e.g. providing information and advice, weekly assignments, the option of keeping a diary and a forum to get in contact with others who have similar complaints. The EMH interventions were developed as stand-alone interventions by the Trimbos Institute (Netherlands Institute of Mental Health and Addiction) at an earlier stage. The following EMH interventions were used in the study: Psyfit: 23 aimed at enhancing mental fitness. Also applied for healthy participants. Strong at work: 24 aimed at gaining insight into work stress and learning skills to cope with it. Colour your Life: 25 aimed at tackling depressive symptoms. Don t Panic Online: 26 aimed at reducing panic symptoms for subclinical and mild cases of panic disorder. Drinking Less: 16 aimed at reducing risky drinking behaviour. Psyfit was found to be effective in decreasing symptoms of depression and anxiety and improving well-being and vitality. 27 Warmerdam and colleagues 14 showed that Colour your Life resulted in significantly lower depression and anxiety scores compared to a waiting-list control group and to significantly higher quality of life scores. The number of participants showing clinically relevant change regarding depression after 12 weeks was significantly higher. Spek and colleagues also found a significantly larger improvement in depressive symptoms compared to a waiting-list control group. 28,29 Drinking Less resulted in more participants who reduced their drinking successfully to within guideline norms, and a significantly larger decrease in mean weekly alcohol consumption than a control group

134 Effectiveness of an e-mental health approach to WHS Table 1 Screening instruments and cut-off points. Aspect Instrument Cut-off point Impaired work functioning Nurses Work Functioning Questionnaire (7 subscales) 4 Red score on 1 subscales and/or orange score on 3 subscales 19 Distress Four-Dimensional Symptoms Questionnaire, distress subscale 32,33 Total score Work-related fatigue Need for recovery subscale of the Dutch Questionnaire on the Experience and Evaluation of Work 35 Standardised total score Risky drinking behaviour AUDIT-C 49 Total score 5 for men, 4 for women 50 Depression Brief Symptom Inventory, depression subscale 51 Mean score (Suicide risk) (One item from Brief Symptom Inventory, depression subscale 51 ) (Score 3 on 0-4 scale) Anxiety Brief Symptom Inventory, anxiety subscale 51 Mean score answers affirmative on the first 4 items plus 4 symptoms affirmative on the following 11 items 54 Panic disorder Patient Health Questionnaire, 53 only assessed for participants identified as having anxiety complaints Posttraumatic stress Dutch translation of the Impact of Event Scale 37,38 Total score

135 CHAPTER 6 In case of positive screening on impaired work functioning (regardless of their mental health status), participants received an onscreen educational leaflet on how to improve their work functioning (available upon request). Control group Participants in the control group filled out the same baseline questionnaire as the EMH-approach group, but did not receive an intervention, and thus no screening results either. However, they were informed that they would receive personalised feedback and a tailored offer of self-help EMH interventions after six months, following the six months follow-up questionnaire. Measures All outcomes were measured at baseline and at three and six months follow-up. Primary outcome The primary outcome of this study was impaired work functioning, measured with the total score of the Nurses Work Functioning Questionnaire (NWFQ). 4 This questionnaire has been developed to assess impaired work functioning in nurses and allied health professionals. In the screening phase, all seven of the original subscales were used. Participants scored either green, orange or red on each subscale. A red score on one or more subscales and/or three or more orange scores led to case identification of impaired work functioning (i.e. scoring above cut-off point on impaired work functioning). 19 Only six of the seven original NWFQ subscales were used for the outcome measure, in contrast to what was described in the trial s design study, 19 because the reproducibility of the impaired decision-making subscale was found to be poor. 30 The total score on the NWFQ was calculated with the 47 items of the remaining six subscales, with a total score range of 0-100, a higher score indicating more severely impaired work functioning. The difference between the EMH-approach group and the control group regarding impaired work functioning was investigated using the continuous outcome and the percentage of individuals who had improved relevantly at follow-up. 31 Secondary outcomes The secondary outcomes included distress, work-related fatigue, posttraumatic stress, and work ability. 134

136 Effectiveness of an e-mental health approach to WHS Distress was measured with the distress subscale of the Four-Dimensional Symptoms Questionnaire (4DSQ). 32,33 The 16-item questionnaire uses a 5-point response scale (0 = no, 4 = very often) and has a total score range of 0-32, a higher score indicating a higher level of distress (cut-off point ). Work-related fatigue after working time was measured using the need for recovery subscale of the Dutch Questionnaire on the Experience and Evaluation of Work (QEEW). 35 The 11-item questionnaire with dichotomous response categories (yes, no) has a total score range of 0-11 and a standardized score range of 0-100, a higher score indicating a higher level of work-related fatigue (cut-off point ). Posttraumatic stress was measured with the Dutch version of the Impact of Event Scale. 37,38 The 15 items can be answered on a 4-point response scale (0 = not at all, 3 = often). Total scores range from 0-75, a higher score indicating a higher level of posttraumatic stress (cut-off point ). Work ability was assessed with the first item of the Work Ability Index (WAI). 40 This item concerns the evaluation of current work ability compared to their lifetime best on an 11-point scale (0 = completely unable to work, 10 = work ability at its best), a higher score indicating a higher level of work ability. Statistical analyses All participants who completed the baseline questionnaire and who screened positive on impaired work functioning and/or impaired mental health (the targeted sample) were analysed, as the work functioning and mental health of these participants could be expected to change due to the intervention. However, since this was not pre-specified in the trial registration, the analyses were also performed with the total sample of participants (i.e. all participants, regardless of their screening results). 6 To describe participants, we used the following demographics: sex, age, occupation, specialization (yes/no), years of working experience, working hours per week, and type of contract. Additionally, the number of participants scoring above cut-off point for impaired work functioning and mental health complaints were calculated. The analyses were performed at the level of the individual employee, according to the intention-to-treat principle. The significance level was set at α = All analyses were carried out using the statistical package IBM SPSS Statistics

137 CHAPTER 6 Drop-out analysis A drop-out analysis was performed to detect whether dropping out of the trial was related to the primary outcome impaired work functioning, and to identify potential predictive variables of drop-out. Dropping out of the trial was defined as completing the baseline and three months follow-up questionnaires, but not the six months follow-up questionnaire; or completing the baseline questionnaire, but none of the follow-up questionnaires. Differences between drop-outs and non drop-outs in impaired work functioning over time in both separate groups were explored in graphs. If different patterns of the effect after three months were detected, a Mann-Whitney U test was performed to test the significance of the differences. In the event of statistically significant differences, a multiple logistic regression analysis was performed with drop-out as the dependent variable, to identify potential predictive variables for drop-out. Screening positive on mental health complaints at baseline (yes/no) and age were included as the independent variables, as we expected that these two aspects might be related to dropping out of the trial. If the multiple logistic regression analysis showed one or both of these aspects to have a statistically significant effect on drop-out, they were included as a covariate in the effect analyses. 41 Effect analysis To analyse the differences over time between the EMH-approach group and the control group on each outcome, Linear Mixed Models (LMM) were applied. If the assumption of a normal distribution of residuals was not met, a log-transformation was used for the LMM and the median and range were used to describe the outcome. Otherwise, the mean and standard deviation were used to describe the outcome. For each outcome, the scores at three and six months follow-up were included as dependent variables in the LMM, while the baseline score was included as a covariate. The main effects of group and time of measurement, and the interaction of group*time of measurement were included as fixed effects in the model. Ward (the cluster level) and subject (the individual level) were included as random effects; however if the cluster level did not have a statistically significant effect, it was considered negligible and was therefore excluded from the model. The effects of interest were the main effect of group (interpreted as the difference between the groups from baseline to six months follow-up) and the interaction effect of group*time of measurement (interpreted as the difference between the groups from three to six months follow-up). For all outcomes in the positively screened subgroup, we calculated Cohen s d 42 by determining the mean difference between the baseline score and the score at follow-up, divided by the pooled standard deviation. For Cohen s d, a score of 0.2 to 0.5 can be considered a small effect, 0.5 to 0.8 a medium effect, and greater than 0.8 a large effect

138 Effectiveness of an e-mental health approach to WHS Additionally, the relative change scores of individuals on impaired work functioning after three and after six months of follow-up compared to their baseline score were calculated. Individuals with a relative improvement on their NWFQ total score of 40% or more, which is the minimal important change (MIC) value of the NWFQ total scale, 31 were defined as relevantly improved. The percentages of individuals who had improved relevantly in each group were compared using a Fisher s exact test, for both three months and six months follow-up. RESULTS Participant flow Figure 1 presents the flow of participants through the trial. From March 15 th until April 26 th, 423 employees (37%) started on the baseline questionnaire. Of those, 366 (32% of invited employees) were eligible for participation, 178 (31%) in the EMH-approach group and 188 (34%) in the control group. In the EMH-approach group, 80 participants (45%) were lost to follow-up, compared to 33 participants (18%) in the control group. Reasons for withdrawal were not assessed. Fifty-six participants (31%) in the EMH-approach group and 126 participants (67%) in the control group completed all three questionnaires. Analyses were performed on the participants who screened positive (primary outcome: EMH N = 75, 54%; control N = 131, 81%), and additionally on all participants (primary outcome: EMH N = 98, 55%; control N = 155, 82%) who had participated in at least one follow-up. Twenty-two participants (17 positively screened) logged into Psyfit, seven logged into Strong at work, four logged into Colour your Life, and no-one logged into Don t Panic Online or Drinking Less. Nine participants (all positively screened) followed an intervention to at least some extent (Psyfit: 6, Colour your Life: 3). 6 Study population at baseline As shown in Table 2, the study groups were quite similar regarding demographic and occupational characteristics. The majority of participants were female and employed as a nurse. Participants in the EMH-approach group had a younger average age of 37, compared to 42 in the control group. The participants worked an average of 31 hours per week and most of them had a permanent position in the hospital. Around 4/5 th of participants screened positive on work functioning impairments and/or impaired mental health, more participants in the control group (N = 161, 86%) than in the EMH-approach group (N = 139, 78%). 137

139 CHAPTER 6 Drop-out analysis Graphs in which the scores of drop-outs and non drop-outs on the primary outcome were compared, showed that in both groups drop-outs had a worse score on impaired work functioning (EMH baseline median = 13, 3 mn follow-up median = 12; C baseline median = 14, 3 mn follow-up median = 11) than non drop-outs (EMH baseline median = 9, 3 mn follow-up median = 8; C baseline median = 12, 3 mn follow-up median = 8) at baseline and three months follow-up. A Mann-Whitney U test identified that these differences were statistically significant in the EMH-approach group (baseline U = 4.688, p = 0.01; 3 mn follow-up U = 970, p = 0.04) and in the entire group of participants (baseline U = ,5, p = 0.01; 3 mn follow-up U = 5.079,5, p = 0.01). In a subsequent logistic regression analysis, age was identified as a statistically significant predictor of drop-out in the entire group (p = 0.02, younger participants had a higher chance of drop-out), but screening positive for mental health complaints at baseline (yes/no) was not (p = 0.16). Therefore, age was included as a covariate in the effect analyses. Intervention effects The results in Table 3 refer to the group of participants who screened positive for impaired work functioning and/or mental health impairments at baseline. The relative frequency of participants who scored above cut-off point on the outcome measures and the mean and median scores (in case of a non-normal distribution) are presented for baseline and both follow-up points, as well as the results of the LMM analyses. Since the random effect of ward (the cluster level) was not statistically significant in any of the analyses, it was excluded from the model in the LMM analyses. Impaired work functioning (primary outcome) The EMH-approach group and the control group improved to a similar degree between baseline and three months follow-up. The EMH-approach group improved further between three and six months, while the control group remained at approximately the same level. As shown in Table 3, in the LMM analysis of impaired work functioning in the positively screened sample of participants, no statistically significant difference between the EMH-approach group and the control group was identified (main effect of group p = 0.77; interaction effect of group*time p = 0.28). The effect size estimate after three and six months was comparably low in both groups. In the LMM analysis of the total sample of participants (data not shown in table), no significant effect of group was found (p = 0.68), but a significant interaction effect of group*time was found (p = 0.04), suggesting there to be a different pattern of scores on impaired work functioning from three to six months follow-up between the EMH-approach group and the control group. A closer look at the median scores on impaired work 138

140 Effectiveness of an e-mental health approach to WHS Table 2 Participant characteristics at baseline for the EMH-approach group and the control group. TOTAL SAMPLE EMHapproach (N = 178) Control (N = 188) POSITIVELY SCREENED SAMPLE EMHapproach (N = 139) Control (N = 161) Variable n (%) n (%) n (%) n (%) Sex Female 147 (83) 145 (77) 113 (81) 126 (78) Age in years (mean (SD)) 37 (12) 42 (11) 38 (12) 42 (12) Occupation Nurse 129 (73) 134 (71) 99 (71) 115 (71) Nurse practitioner 11 (6) 22 (12) 7 (5) 18 (11) Surgical nurse 0 (0) 5 (3) 0 (0) 5 (3) Anesthetic nurse 0 (0) 0 (0) 0 (0) 0 (0) Allied health professional 38 (21) 27 (14) 33 (24) 23 (14) Nursing specialization Yes 74 (57) 86 (64) 57 (58) 75 (65) Years of experience (mean (SD)) 10 (10) 11 (10) 11 (10) 11 (10) Working hours per week according to contract (mean (SD)) Type of contract 31 (5) 31 (6) 31 (5) 31 (6) Permanent position 160 (91) 174 (93) 125 (91) 150 (94) Fixed-term contract 13 (7) 12 (6) 11 (8) 9 (6) Temporary employment 0 (0) 0 (0) 0 (0) 0 (0) Other 3 (2) 1 (1) 1 (1) 1 (1) Impaired work functioning a (above cut-off ) Work functioning impairments 107 (60) 131 (70) 107 (77) 131 (81) Impaired mental health (above cut-off ) Impaired mental health (above cut-off of one or more of the six mental health aspects) 109 (61) 119 (63) 109 (78) 119 (74) Distress 41 (23) 48 (26) 41 (30) 48 (30) Work related fatigue 61 (34) 65 (35) 61 (44) 65 (40) Posttraumatic stress 24 (14) 19 (10) 24 (17) 19 (12) Screened positive on impaired work functioning and/or impaired mental health 139 (78) 161 (86) 139 (100) 161 (100) 6 a Note: Work functioning is presented here including the subscale impaired decision-making, as it was included in the screening at baseline. 139

141 CHAPTER 6 Table 3 Descriptives and analysis results on primary and secondary outcomes of the positively screened sample at baseline, 3- and 6-months follow-up. E-mental health approach group Relative frequency above cut-off (%) Median (range) Mean (SD) Effect size (95% CI) Primary outcome Impaired work functioning (NWFQ 0-100) a b 91/139 (66) 14 (0-56) 3 mn 33/62 (53) 10 (0-39) 0.19 ( ) 6 mn 19/52 (37) 8 (0-41) 0.16 ( ) Secondary outcomes Distress (4DSQ, 0-32) b 41/139 (30) 7 (0-32) 3 mn 9/61 (15) 4 (0-29) 0.20 ( ) 6 mn 10/52 (19) 5 (0-29) 0.07 ( ) Work-related fatigue (QEEW, 0-100) b 61/139 (44) 44 (28) 3 mn 22/61 (36) 36 (31) 0.16 ( ) 6 mn 14/52 (27) 34 (30) 0.02 ( ) Posttraumatic stress (IES, 0-75) b 24/139 (17) 3 (0-71) 3 mn 10/61 (16) 1 (0-48) 0.07 ( ) 6 mn 5/51 (10) 0 (0-31) 0.24 ( ) Work ability (WAI, 0-10) b 7 (1) 3 mn 8 (1) 0.14 ( ) 6 mn 8 (2) 0.05 ( ) a Note: NWFQ total scores were calculated without the subscale impaired decision-making. b Number analysed in EMH-approach group: N = 75 (impaired work functioning), N = 74 (distress and workrelated fatigue), N = 73 (posttraumatic stress and work ability); numbers analysed in Control group: N = 131 (all outcomes). b, baseline; 3 mn, follow-up after 3 months; 6 mn, follow-up after 6 months. functioning revealed that both groups improved to a similar degree between baseline and three months follow-up, and that the EMH-approach group further improved between three and six months follow-up while the control group slightly deteriorated. 140

142 Effectiveness of an e-mental health approach to WHS Control group p-value (LMM analyses) b Relative frequency above cut-off (%) Median (range) Mean (SD) Effect size (95% CI) group group*time 110/161 (68) 14 (0-54) /124 (49) 10 (0-38) 0.26 ( ) 60/116 (52) 10 (0-44) 0.24 ( ) 48/161 (30) 6 (0-32) /123 (20) 5 (0-29) 0.26 ( ) 26/116 (22) 5 (0-30) 0.14 ( ) 65/161 (40) 39 (30) /123 (34) 35 (30) 0.12 ( ) 39/116 (34) 37 (31) 0.02 ( ) 19/161 (12) 3 (0-48) /122 (11) 0 (0-62) 0.31 ( ) 9/116 (8) 0 (0-48) 0.26 ( ) 6 8 (2) (1) ( ) 8 (1) 0.01 ( ) In Table 4, the percentages of individual employees with a relevant improvement on work functioning after three and after six months compared to their baseline score are shown. After three months, in the positively screened sample as well as the total sample, roughly the same percentage of participants in both groups had improved relevantly regarding work functioning compared to their baseline score. After six months, more participants in the EMH-approach group than in the control group had improved relevantly compared to baseline, in both the positively screened sample (EMH 36%; control 28%) and the total sample (EMH 40%; control 30%). However, these differences were not statistically significant (p = 0.36 and p = 0.21, respectively). 141

143 CHAPTER 6 Table 4 Participants whose work functioning had improved with at least the minimal important change at 3- and 6-months follow-up compared to baseline: descriptives and analysis results. EMH-approach Control group p-value Relative frequency (%) Relative frequency (%) (Fisher s exact test) Positively screened sample 3 mn 18/60 (30%) 37/123 (30%) mn 18/50 (36%) 32/115 (28%) Total sample 3 mn 24/80 (30%) 46/142 (32%) mn, follow-up after 3 months; 6 mn, follow-up after 6 months. 6 mn 27/68 (40%) 40/134 (30%) Secondary outcomes As shown in Table 3, both groups improved over time regarding distress, work-related fatigue, and posttraumatic stress, with the largest improvement between baseline and three months of follow-up. On distress and work-related fatigue, the EMH-approach group had a larger overall improvement than the control group (non-significant). In the LMM analyses on distress, work-related fatigue, posttraumatic stress, and work ability in the positively screened sample, no statistically significant differences were found between the EMH-approach group and the control group (main effect of group 0.36 p 0.62; interaction effect of group*time 0.12 p 0.83). Effect sizes in both groups were fairly similar, small to non-relevant. In the LMM analyses on the secondary outcomes in the total sample of participants (data not shown in table), no significant differences were found between the EMH-approach group and the control group either (0.31 p 0.97). DISCUSSION The results of our study suggest that an e-mental health (EMH) approach of workers health surveillance (WHS), consisting of online screening on impaired work functioning and impaired mental health followed by personalised feedback and a tailored offer of self-help EMH interventions, shows no significant improvement in impaired work functioning, distress, work-related fatigue, posttraumatic stress, and work ability to a larger extent than a control group. Compliance to the EMH interventions was low, which impedes drawing a conclusion about the effect of this part of the intervention. Screening and personalised feedback was received by all participants in the intervention group. Although the study had insufficient power, the low effect sizes do not give reason to expect a relevant effect of screening and feedback. The outcomes may be of value for future meta-analytic work. 142

144 Effectiveness of an e-mental health approach to WHS One third of the employees who were invited, participated in the study. Of these participants, more than 80% screened positive for at least mild impairments in work functioning and/or mental health. Both the intervention group and the control group improved over time on work functioning, distress, work-related fatigue, and posttraumatic stress, with no statistically significant difference between the groups. However, when including all participants in the analyses and not only those who had screened positive on impairments at baseline, the work functioning of the EMH-approach group showed a significantly different pattern compared to the control group, as the EMH-approach group further improved between three and six months after baseline while the control group did not. After six months, a relevant improvement of work functioning was found for 36% of positively screened participants in the intervention group and 28% in the control group, but the difference between the groups was non-significant. Interpretation of results First of all, our study had a high percentage of participants who screened positive for at least mild impairments. This included screening positive on impairments in work functioning, on one or more mental health complaints or both. In choosing our cut-off points, we aimed for high sensitivity, since we did not want to miss participants who might need help. The cut-off points that we applied for the mental health complaints were all validated. However, high sensitivity generally comes at the expense of high specificity, which might have led to higher numbers of false positives in our study. We formulated the online feedback mildly, careful not to speak of diagnosis or mental health problems, to prevent incorrect interpretation. Additionally, the relatively high number of screening instruments might have led to a high overall percentage of participants who screened positive for at least one of the screeners. Our intervention consisted of two parts. First, the participants in the intervention group underwent online screening on impaired work functioning and impaired mental health, followed by personalised feedback on their screening results. Subsequently, they were offered a tailored offer of EMH interventions. In addition, participants with impaired work functioning received an onscreen educational leaflet on how to improve their work functioning. Two scenarios might explain our not finding an effect of the intervention: programme failure and theory failure: 43 the intervention was not carried out as intended (programme failure), or the intervention is not effective (theory failure). 6 The process evaluation that was carried out alongside this randomised controlled trial 44 offers some information on potential programme failure. The personalised feedback was received by all participants in the intervention group, since it appeared onscreen immediately after filling out the baseline questionnaire and was sent to the participants address automatically. The onscreen educational leaflet on how to improve work 143

145 CHAPTER 6 functioning was also sent automatically to participants with impaired work functioning. However, the compliance to the subsequently offered self-help EMH interventions was low. Only 28 participants logged into an EMH intervention, and 6% (N = 9) of the positively screened participants in the intervention group started an EMH intervention to at least some extent. Regarding the second part of the intervention (the EMH interventions), program failure may therefore have occurred. Participants offered no explanation why they did not follow an EMH intervention. 44 Three explanations are conceivable. Firstly, there is a reported trend in the literature of a low perception of need for mental health interventions. Lexis and colleagues found that 43% of employees who were identified with mild to severe depressive complaints, did not report to experience health complaints themselves. 45 Codony and colleagues found that merely a third of those who had a mental disorder in the past 12 months, had a perceived need of mental healthcare. 46 Since our study regarded a preventive setting and we chose for high sensitivity in our screening, perhaps the perceived need of our participants was insufficient to motivate them to log into and follow an EMH intervention. Secondly, some of the participants (N = 9) reported problems with logging into the interventions, due to technical problems and/or inadequate computer skills, which might have posed a problem for more participants. A third explanation is that the channelling from the personalised feedback towards the EMH interventions might not have been attractive enough to encourage participants to follow an EMH intervention. The possibility of theory failure should also be considered. The intervention consisted of screening and personalised feedback on screening results including channelling towards EMH interventions, an onscreen educational leaflet on how to improve work functioning (if applicable), and following the EMH interventions. Most of the EMH interventions that were used in our study have been found effective to reduce symptoms of impaired mental health in previous research, 14,16,27-29 supporting our hypothesis that an EMH-approach to WHS, including EMH interventions (if complied to), might be effective in improving mental health and improving work functioning. However, it should be noted that for these previous studies, most participants had actively responded to advertisements targeting people who wanted to work on their depressive symptoms or their mental fitness. Therefore, these participants actively sought help and improvement through EMH interventions. This differs considerably from our setting, as our participants took part in WHS targeting work functioning and mental health and might not have been as much aware that they would be offered EMH interventions. However, since the intervention was not carried out as intended, we cannot conclude that the complete EMH-approach to WHS targeting work functioning and mental health of healthcare employees is ineffective. Moreover, we found that when looking at the total 144

146 Effectiveness of an e-mental health approach to WHS sample of participants, both groups improved over time, but the EMH-approach group continued to improve between three and six months after baseline while the control group slightly deteriorated in this time interval. Possibly, we were able to find a significant effect in this total sample, because the number of participants was higher in this group and the analysis was therefore better powered to find existing differences. Since the EMH interventions themselves were hardly followed, this suggests that the other elements of the complete EMH-approach possibly increasing awareness - might have had some (delayed) effect on work functioning. However, the results in this total sample of participants are not easily interpreted, since only the personalised feedback was received by all participants in the intervention group, and the observed effect did not occur until later in time. Limitations Several limitations of our study can be noted. First of all, we did not meet our required sample size for sufficient power, set at 189 participants in each group who completed participation. This increases the chance of finding non-significant p-values despite trends for differences. The data show that, regarding impaired work functioning, a higher percentage of participants in the EMH-approach group than in the control group improved to a relevant degree compared to their own baseline scores, but this difference was not statistically significant, which might have been a result of insufficient power. However, the observed effect sizes were very small, and in most cases were fairly similar between the groups. A second limitation of our study was the fairly high and selective drop-out rate of participants, especially in the intervention group. Drop-outs had higher scores on impaired work functioning at baseline and three months follow-up than participants who did not drop out of the trial. We do not know why this occurred, since we did not assess reasons for drop-out. We received mixed reactions to the personalised but automatic feedback on screening results and the for some participants unexpected offer to follow an EMH intervention. We suppose this might have led to resistance and the higher drop-out in the intervention group. The high and selective drop-out may have introduced bias, although we have no way of knowing in which direction this possible bias occurred. 6 Thirdly, as discussed before, the compliance to the offered EMH interventions was low, complicating studying the effect of the complete EMH-approach to WHS. Lastly, we studied the effects of the EMH-approach in a group of positively screened participants, regardless of what they screened positive for. Since not everyone screened positive for every impairment of complaints and the offered intervention was tailored to each individual, it might not be reasonable to expect an improvement for every impairment or complaint if examining the total group. 145

147 CHAPTER 6 Implications for practice and further research Our study confirms that preventive actions are essential for nurses and allied health professionals, since we identified that more than 80% of participants show at least some level of impaired work functioning and/or symptoms of mental health problems. We endeavoured to improve work functioning and mental health through online screening, personalised feedback, and a subsequent tailored offer of self-help EMH interventions. We think that targeting work functioning is an important approach, as the ultimate goal of occupational healthcare is to keep employees functioning well and as healthy as possible. However, we were unsuccessful in studying the EMH-approach, because very few participants followed an EMH intervention to at least some degree. Therefore, we recommend further research on two aspects. First, it is essential to identify the specific needs and wishes that nurses and allied health professionals have regarding their work related health and to study how they want to be supported to stay healthy and well-functioning at work. Possibly, a more comprehensive WHS including important other factors of their work, such as physical aspects (e.g. musculoskeletal complaints), would increase their interest and participation. Secondly, it should be investigated whether EMH interventions are suitable and acceptable for a WHS setting for nurses and allied health professionals, and if they would prefer some degree of contact with a healthcare provider. It is recommended to explore the possibility of blended care, i.e. combining an offer of an EMH intervention with several coaching sessions. Moreover, it could be useful to apply elements of persuasive design to encourage employees to follow an EMH intervention. 47,48 146

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149 CHAPTER 6 27 Bolier L, Haverman M, Bohlmeijer E. Psyfit online - Randomized effect study on an online mental fitness self-help program - Internal report [in Dutch: Psyfit online - Gerandomiseerde effectstudie naar een e-mental fitness zelfhulpprogramma - Intern rapport]. Utrecht, the Netherlands: Trimbos-instituut, Spek V, Nyklicek I, Smits N et al. Internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years old: a randomized controlled clinical trial. Psychol Med 2007; 37: Spek V, Cuijpers P, Nyklicek I et al. One-year follow-up results of a randomized controlled clinical trial on internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years. Psychol Med 2008; 38: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Psychometric properties of the Nurses Work Functioning Questionnaire (NWFQ). PLoS One 2011; 6:e Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Interpretability of change in the Nurses Work Functioning Questionnaire: minimal important change and smallest detectable change. J Clin Epidemiol 2012; 65: Terluin B. The Four Dimensional Symptom Questionnaire (4DSQ) [in Dutch: De Vierdimensionele Klachtenlijst (4DKL) in de huisartspraktijk]. De Psycholoog 1998; 33: Terluin B, van Marwijk HW, Ader HJ et al. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry 2006; 6: van Rhenen W, van Dijk FJ, Schaufeli WB, Blonk RW. Distress or no distress, that s the question: A cutoff point for distress in a working population. J Occup Med Toxicol 2008; 3:3. 35 van Veldhoven M & Meijman T. The measurement of psychosocial job demands with a questionnaire: the questionnaire on the experience and evaluation of work (QEEW) [in Dutch: Het meten van een psychosociale arbeidsbelasting met een vragenlijst: de vragenlijst beleving en beoordeling van arbeid (VBBA)]. Amsterdam, the Netherlands: Dutch Institute for Working Conditions, Broersen JPJ, Fortuin RJ, Dijkstra L et al. Monitor occupational health and safety: key indicators and limits [in Dutch: Monitor Arboconvenanten: kengetallen en grenswaarden]. TBV 2004; 12: Brom D & Kleber RJ. The Impact of Event Scale [in Dutch: De Schok Verwerkings Lijst]. Nederlands Tijdschrift voor de Psychologie 1985; 40: Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med 1979; 41: van der Ploeg E & Kleber RJ. Acute and chronic job stressors among ambulance personnel: predictors of health symptoms. Occup Environ Med 2003; 60:i40-i Tuomi K, Ilmarinen J, Jahkola A et al. Work Ability Index. Helsinki, Finland: Finnish Institute of Occupational Health, DeSouza CM, Legedza AT, Sankoh AJ. An overview of practical approaches for handling missing data in clinical trials. J Biopharm Stat 2009; 19: Cohen J. Statistical power analysis for the behavioral sciences. 2nd edn. Hillsdale, N.J.: Lawrence Erlbaum Associates, Kristensen TS. Intervention studies in occupational epidemiology. Occup Environ Med 2005; 62: Ketelaar SM, Gärtner FR, Bolier L et al. Mental Work - A Workers Health Surveillance mental module for nurses and allied health care professionals: Process evaluation of a randomized controlled trial. J Occup Environ Med 2013; 55: Lexis MA, Jansen NW, Stevens FC et al. Experience of health complaints and help seeking behavior in employees screened for depressive complaints and risk of future sickness absence. J Occup Rehabil 2010; 20: Codony M, Alonso J, Almansa J et al. Perceived need for mental health care and service use among adults in Western Europe: results of the ESEMeD project. Psychiatr Serv 2009; 60: Fogg BJ. A Behavior Model for Persuasive Design, Accessed 6 December Kelders SM, Kok RN, Ossebaard HC, Van Gemert-Pijnen JE. Persuasive system design does matter: a systematic review of adherence to web-based interventions. J Med Internet Res 2012; 14:e

150 Effectiveness of an e-mental health approach to WHS 49 Bush K, Kivlahan DR, McDonell MB et al. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med 1998; 158: Gual A, Segura L, Contel M et al. Audit-3 and audit-4: effectiveness of two short forms of the alcohol use disorders identification test. Alcohol Alcohol 2002; 37: de Beurs E. de Beurs E. Brief Symptom Inventory (BSI): Manual [in Dutch: Brief Symptom Inventory (BSI): Handleiding]. Leiden, the Netherlands: Pits Publishers, Leiden, the Netherlands: Pits Publishers, de Beurs E & Zitman FG. The Brief Symptom Inventory (BSI): The reliability and validity of a brief alternative of the SCL-90 [in Dutch: De Brief Symptom Inventory (BSI): De betrouwbaarheid en validiteit van een handzaam alternatief voor de SCL-90]. Maandblad Geestelijke Volksgezondheid 2006; 61: Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 1999; 282: Lowe B, Grafe K, Zipfel S et al. Detecting panic disorder in medical and psychosomatic outpatients: comparative validation of the Hospital Anxiety and Depression Scale, the Patient Health Questionnaire, a screening question, and physicians diagnosis. J Psychosom Res 2003; 55:

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152 7 IMPROVING WORK FUNCTIONING AND MENTAL HEALTH OF HEALTHCARE EMPLOYEES USING AN E-MENTAL HEALTH APPROACH TO WORKERS HEALTH SURVEILLANCE: PRETEST-POSTTEST STUDY Sarah M. Ketelaar Karen Nieuwenhuijsen Linda Bolier Odile Smeets Judith K. Sluiter Accepted for publication in Saf Health Work.

153 CHAPTER 7 ABSTRACT Background: Mental health complaints are quite common in healthcare employees and can have adverse effects on work functioning. The aim of this study was to evaluate an e-mental health (EMH) approach to workers health surveillance (WHS) for nurses and allied health professionals. Using the waiting-list group of a previous randomized controlled trial with high drop-out and low compliance to the intervention, we studied the pre-post effects of the EMH approach in a larger group of participants. Methods: We applied a pretest-posttest study design. The WHS consisted of online screening on impaired work functioning and mental health followed by online automatically generated personalized feedback, online tailored advice and access to self-help EMH interventions. The effects on work functioning, stress, and work-related fatigue after three months were analyzed using paired t-tests and effect sizes. Results: One hundred twenty-eight nurses and allied health professionals participated at pretest as well as posttest. Significant improvements were found on work functioning (p = 0.01) and work-related fatigue (p < 0.01). Work functioning had relevantly improved in 30% of participants. A small meaningful effect on stress was found (Cohen s d = 0.23) in the participants who had logged onto an EMH intervention (20%, N = 26). Conclusion: The EMH approach to WHS improves the work functioning and mental health of nurses and allied health professionals. However, since we found small effects and participation in the offered EMH interventions was low, there is ample room left for improvement. 152

154 Pre-post effects of an e-mental health approach to WHS INTRODUCTION Working as a nurse involves dealing with a range of potential workplace stressors, such as psychological and emotional demands. 1 Unsurprisingly, mental health complaints including burnout, posttraumatic stress, anxiety and depression are quite common in nurses. 2 Impaired mental health can have adverse effects endangering the health and safety of the nurses themselves but also of their patients. 3,4 Consequently, it seems worthwhile to pay preventive attention to the mental health and work functioning of nurses. One promising preventive tool may be a mental module for workers health surveillance (WHS). WHS can be used to identify and treat health complaints relevant to work and it should be an essential component of programs aimed at the protection of employees. 5 In the Netherlands, employers are obliged to periodically offer employees the opportunity to undergo a medical examination targeted towards preventing or limiting the risks for the employees work-related health. A job-specific assessment should be applied to tailor the interventions to detected work functioning impairments. 6 Attention has been paid to the occupational hazards of healthcare employees, but WHS targeting work functioning as well as mental health of nurses and allied health professionals has not been studied in this way. We have developed a self-help e-mental health (EMH) approach to a mental module for WHS, consisting of online screening on impaired work functioning and impaired mental health followed by personalized online feedback and online tailored advice combined with access to self-help EMH interventions. Online screening offers a practical and efficient method to screen for self-reported impaired work functioning and impaired mental health. Several EMH interventions are available as subsequent interventions. Self-help EMH interventions may offer some advantages over face-to-face healthcare, e.g. they can be followed in a self-chosen time and place and at one s own pace. Research has shown that unguided self-help EMH interventions have positive outcomes for a variety of mental health aspects. 7,8 However, their effects on work functioning have not been studied in a specific working population such as nurses and allied health professionals. Moreover, EMH interventions have thus far only been offered as stand-alone interventions for a specific common mental disorder. In our study, we offer a choice of EMH interventions, tailored to the specific complaints as indicated by the individual s screening results. 7 We have studied the EMH approach to WHS in a randomized controlled trial (RCT). 9 Because we applied a waiting-list design for the control group (i.e. the control group was enrolled in the EMH approach to WHS after completion of the trial), we had the opportunity to study the pre-post effects of the EMH approach in a larger group of participants. For 153

155 CHAPTER 7 this study, we have focused on three outcomes: impaired work functioning, stress complaints, and work-related fatigue. We have chosen stress complaints and work-related fatigue as outcome measures since we consider them to form a generic and encompassing measure of mental health in healthcare employees. In this study, we addressed the following research question: Does our EMH approach to WHS improve work functioning, stress, and work-related fatigue in hospital nurses and allied health professionals? MATERIALS AND METHODS Study design and participants The study participants originated from two study arms of a previous RCT performed in The study population for this trial was formed by all nurses, including surgical nurses and anesthetic nurses, and allied health professionals (such as physiotherapists and radiotherapists) employed at one academic hospital in the Netherlands. Since the trial regarded a preventive study, participants were included if they were not, or were not expecting to be on sick leave for more than two weeks at baseline. The Medical Ethics Committee of the Academic Medical Center Amsterdam approved the study. All participants intervention T0 (N = 178) T1 Original EMH approach group Original control group T0 (N = 117) T1 Timeline of trial intervention B 3 mn 6 mn 9 mn Figure 1 Schematic representation of the scores that were used as pretest and posttest scores. T0, pretest scores; T1, posttest scores; B, baseline; 3 mn, follow-up after 3 months; 6 mn, follow-up after 6 months; 9 mn, follow-up after 9 months (only assessed in the original control group); N, number of participants who filled out the pretest questionnaire and were invited for filling out the posttest questionnaire. 154

156 Pre-post effects of an e-mental health approach to WHS gave their written informed consent before taking part. Participation rate of the RCT at baseline was 32%. In the original EMH approach group, 178 participants filled out the baseline questionnaire and were offered the intervention. Participants from the control group who filled out the last follow-up questionnaire six months after baseline were offered the same intervention as the original EMH approach group. They were also asked if we could contact them again in future. Those who agreed (N = 117) were invited to complete an extra follow-up questionnaire three months after the last RCT follow-up questionnaire. The original EMH approach group and the original control group were then combined to study the effect of offering an EMH approach to WHS in a pre-post design. Which scores were used for this single-group pretest-posttest study is shown in Figure 1. The outcome measures were assessed using online questionnaires. Thus, in total, 295 participants filled out the pretest questionnaire and were invited for the posttest questionnaire. Forty-three percent (N = 128) also filled out the posttest questionnaire. Intervention The intervention consisted of three parts: 1. Participants were screened on impaired work functioning (seven subscales) and impaired mental health (stress, work-related fatigue, risky drinking behavior, depression including suicide risk, anxiety including panic disorder, and posttraumatic stress disorder) using the pretest questionnaire (see Gärtner et al. 10 for information on the instruments and cut-off points that were used). 2. All participants received automatically generated personalized feedback on screening results, onscreen and by The personalized feedback was followed by online tailored advice, consisting of an invitation to follow an EMH intervention and (if applicable) the receipt of an onscreen educational leaflet with advice per subscale on how to improve work functioning. In Table 1 an overview is given of the algorithm used for tailoring the advice. 7 The EMH interventions that were used are self-help interventions on the Internet aimed at reducing specific mental health complaints or enhancing wellbeing: Psyfit: 11 aimed at enhancing mental fitness. Strong at work: 12 aimed at gaining insight into work stress and learning skills to cope with it. Colour your Life: 13 aimed at tackling depressive symptoms. Don t Panic Online: 14 aimed at reducing panic symptoms for subclinical and mild cases of panic disorder. Drinking Less: 8 aimed at reducing risky drinking behavior. 155

157 CHAPTER 7 Table 1 Algorithm used for tailoring the advice based on screening results. Screening on impaired work functioning Screening on 1 mental health complaints Tailored advice Negative Negative 1. Invitation to follow EMH intervention Psyfit. Positive Negative 1. Receipt of onscreen educational leaflet with advice to improve work functioning. 2. Invitation to follow EMH intervention Psyfit. Negative Positive 1. Invitation to follow 1 EMH intervention(s); offer based on specific symptoms and work-relatedness of symptoms. a Positive Positive 1. Receipt of onscreen educational leaflet with advice to improve work functioning. 2. Invitation to follow 1 EMH intervention(s); offer based on specific symptoms and work-relatedness of symptoms. a a Participants were mostly offered a choice of 2 or 3 EMH interventions to leave room for personal preferences. The interventions are mainly based on the principles of cognitive behavioral therapy and combine a variety of aspects, e.g. providing information and advice, weekly assignments, and a forum to get in contact with others with similar complaints. The EMH interventions were developed as stand-alone interventions by the Trimbos Institute (Netherlands Institute of Mental Health and Addiction) at an earlier stage. In separate trials, Psyfit, Colour your Life, and Drinking Less have had positive outcomes. 7,8,15,16 Few participants in the original EMH approach group had logged onto an EMH intervention. 17 We decided to slightly adapt the wording of the personalized feedback and the information about the offered EMH interventions for the original control group, to encourage following an EMH intervention. Measures Impaired work functioning was measured with the total score of the Nurses Work Functioning Questionnaire (NWFQ), 3 using the six final subscales: 18 cognitive aspects of task execution and general incidents, causing incidents at work, avoidance behavior, conflicts and irritations with colleagues, impaired contact with patients and their family, and lack of energy and motivation. The NWFQ has 47 items with a total standardised sum score range of Stress was measured with the distress subscale of the Four-Dimensional Symptoms Questionnaire (4DSQ). 19,20 The 16-item questionnaire uses a 5-point response scale (0 = no, 4 = very often) and has a total score range of

158 Pre-post effects of an e-mental health approach to WHS Work-related fatigue after working time was measured using the need for recovery subscale of the Dutch Questionnaire on the Experience and Evaluation of Work (QEEW). 21,22 The 11-item questionnaire with dichotomous response categories (yes, no) has a total score range of 0-11 and a standardized score range of For all outcomes, higher scores indicate a higher level of impairment. Statistical analyses All participants with a score on pretest and posttest were analyzed. We also performed subgroup analyses with participants who had logged onto an EMH intervention. Paired t-tests were used to determine if there were statistically significant differences between scores on pretest and posttest. The significance level was set at α = Furthermore, we analyzed the size of the effects to determine their relevance. For impaired work functioning, we calculated the relative change scores of individuals at posttest compared to their pretest score. Individuals with a relative improvement on their NWFQ total score of 40% or more, which is the minimal important change (MIC) value of the NWFQ total scale, 23 were defined as relevantly improved. For stress and work-related fatigue, we calculated Cohen s d 24 by determining the mean difference between the pretest score and the posttest score, divided by the pooled standard deviation. For Cohen s d, a score of 0.2 to 0.5 can be considered a small effect, 0.5 to 0.8 a medium effect, and greater than 0.8 a large effect. 24 All analyses were carried out using IBM SPSS Statistics 19. RESULTS In Table 2, the participant characteristics are shown. Most participants were female and employed as a nurse, and had a permanent position at the hospital. Three quarters of the participants screened positive at pretest on impaired work functioning or impaired mental health, or both. 7 All participants received online feedback on their personal screening results. The 75 participants (59%) who screened positive on impaired work functioning received the onscreen educational leaflet with advice on how to improve their work functioning. All participants were offered access to EMH interventions: 55 participants (43%) screened negative on impaired mental health and were offered access to Psyfit, while 73 participants (57%) screened positive and were offered access to EMH interventions tailored to their screening results. Twenty percent (N = 26) of the participants logged on at least once to 157

159 CHAPTER 7 Table 2 Participant characteristics (pretest). Descriptive n (%) Mean SD Gender (total N = 128) Female 99 (77) Age in years (total N = 128) Occupation (N = 128) Nurse 89 (70) Nurse practitioner 12 (9) Allied health professional 27 (21) Years of experience (total N = 127) Working hours per week according to contract (total N = 126) 31 6 Type of contract (total N = 127) Permanent position 118 (93) Fixed-term contract 8 (6) Other 1 (1) Impaired work functioning (above cut-off ) (total N = 128) a Work functioning impairments (red score on 1 subscales and/or orange score on 3 subscales) 10 Impaired mental health (above cut-off ) (total N = 128) Impaired overall mental health (above cut-off of 1 or more of the 6 mental health aspects) 75 (59) 73 (57) Stress, above cut-off ( 11) (21) Work-related fatigue, above cut-off ( 54.5) 26,27 40 (31) Screened positive on impaired work functioning a and/or impaired mental health 97 (76) a Work functioning is presented here including the subscale impaired decision-making, as it was included in the pretest screening. 10 an EMH intervention. Three of these participants logged on to two EMH interventions. Twenty-three participants logged on to Psyfit, four logged on to Strong at work, and two logged on to Colour your Life. Nine participants followed an EMH intervention to some extent: eight partly followed Psyfit and one partly followed Colour your Life. No one completed an EMH intervention. As shown in Table 3, the score on impaired work functioning decreased from 12 to 11 after the intervention of screening, personalized online feedback and online advice plus access to EMH interventions (p = 0.01). Thirty percent of the participants had relevantly improved work functioning at posttest. When looking specifically at the subgroup of participants 158

160 Pre-post effects of an e-mental health approach to WHS Table 3 Scores on pre- and posttest, mean difference, paired t-test results, percentage whose work functioning improved with at least the minimal important change (% MIC), and effect sizes (ES). Pretest Posttest Pretest - Posttest N a M SD M SD Mean diff t P MIC, n (%) ES (95% CI) Total group of participants Impaired work functioning (NWFQ, 0-100) (30) b Stress (4DSQ, 0-32) ( ) Work-related fatigue (QEEW, 0-100) ( ) Complying subgroup c Impaired work functioning (NWFQ, 0-100) (27) Stress (4DSQ, 0-32) ( ) Work-related fatigue (QEEW, 0-100) ( ) a The N varies due to missing values on the outcomes. b Total N is 125, because three participants had scored 0 on pretest and thus a relative improvement could not be calculated. c Including only participants who logged on at least once in an EMH intervention

161 CHAPTER 7 who had logged onto an EMH intervention, the decrease in score on impaired work functioning is also statistically significant (p = 0.04). The score on stress decreased between pretest and posttest (6 to 5), but this difference was not statistically significant (p = 0.10). The effect size was less than 0.2, thus the effect does not seem meaningful. In the subgroup who logged onto an EMH intervention the score regarding stress also decreased non-significantly (7 to 5, p = 0.27). However, in this subgroup the effect size was 0.23, indicating a small effect. Regarding work-related fatigue, the score significantly decreased after the intervention (35 to 29, p < 0.01). In the subgroup of participants who logged onto an EMH intervention, the score also decreased, although non-significant. The effect size in both the total group and the subgroup was less than 0.2. Regarding all three outcomes, the subgroup of participants who had logged on at least once to an EMH intervention scored worse than the total group, both at pretest and at posttest. However, they also showed a larger improvement over time. DISCUSSION A mental module for WHS, consisting of online screening on impaired work functioning and impaired mental health followed by personalized online feedback and online tailored advice combined with access to self-help EMH interventions, led to a statistically significant improvement of work functioning and work-related fatigue and had a small meaningful positive effect on stress in nurses and allied health professionals. In this study, the outcomes of interest were work functioning and mental health of nurses and allied health professionals. The effects of WHS regarding these outcomes have not been studied before. This is an important approach, since ultimately occupational healthcare aims to keep employees functioning well and as healthy as possible. We used the waiting-list control group of our previous RCT to enlarge the group of participants of the EMH approach to WHS, and especially the group of participants who had participated at pretest as well as posttest. By doing so, we were able to increase our certainty about the effects of the mental module for WHS on several outcomes. Furthermore, because we studied the effects in participants who had a score on pretest as well as posttest, our results are not obscured due to the intention-to-treat principle and thus show the maximum effect that the mental module for WHS has had on those employees who decided to participate in our study. From our previously performed RCT, 160

162 Pre-post effects of an e-mental health approach to WHS we know that the control group (who had not yet received the intervention at that time) improved over time. 9 However, a reduction of complaints is not uncommon in RCT control groups and in our study could have stemmed from filling out questionnaires on work functioning and mental health, making people aware of their mental health state even if they did not receive feedback on screening results and subsequent interventions. Because only few of the participants in the original EMH approach group logged onto an EMH intervention, 17 we slightly adapted the wording of the personalized feedback and the information about the offered EMH interventions for the original control group, to encourage following an EMH intervention. Using post-hoc analyses, we did not find statistically significant differences between the original EMH approach group and the original control group on pretest and posttest. All participants received personalized online feedback and an offer to follow one or more EMH interventions. We found a statistically significant improvement of work functioning and the work functioning of 30% of the participants in this study had relevantly improved after three months. In addition, we found a statistically significant improvement of work-related fatigue, although the size of this effect did not seem meaningful since the effect size was below 0.2. Regarding stress, we also found a small, but not statistically significant, improvement over time. Therefore, it seems that the WHS has an effect on work-related outcomes, but not on the more general outcome of stress. Participants who screened positive on impaired work functioning not only received access to one or more EMH interventions, but also an onscreen educational leaflet with advice on how to improve their work functioning. Although we are not sure whether these participants read and applied the advice, it might have generated a positive effect on the work-related outcomes. As stated above, the work functioning of 30% of the participants in this study had relevantly improved after three months, comparable to what we found in the EMH approach group (30%) and the control group (32%) in the RCT that we performed previously. After six months compared to baseline, this percentage was still comparable in the control group (30%), but a larger percentage of the EMH approach group (40%) had improved their work functioning. 9 It might take longer than three months to achieve a clinically relevant improvement in the majority of healthcare employees. It is conceivable that it takes time to apply advice to your work activities and to talk it over with your supervisor. 7 The subgroup of participants who had logged on at least once to an EMH intervention scored worse than the total group on all outcomes, both at pretest and posttest. However, they also showed a larger improvement over time, indicating that people who felt relatively worse or received online feedback indicating more impairments were more 161

163 CHAPTER 7 inclined to try the EMH intervention that they were offered and possibly benefitted more from it. However, the EMH interventions were not followed by many participants, since only 26 employees who fully participated in this pretest-posttest study logged onto an intervention. In this subgroup, we found a small positive effect on stress, thus although it was not statistically significant it can be considered a meaningful effect. Therefore, to target stress, logging onto an EMH intervention seems a valuable addition to the mental module for WHS. However, the low compliance to the EMH interventions should be addressed. Several reasons may underlie the low compliance. Firstly, since our study regarded a preventive setting, we think that the perceived need of our participants was insufficient to motivate them to log onto and follow an EMH intervention. This idea is supported by findings in other studies. 28,29 Secondly, some of the participants (N = 5) reported problems with logging onto the interventions due to technical problems and/or inadequate computer skills, which might have posed a problem for more participants. A third explanation might be that the channelling from the personalized online feedback towards the EMH interventions might not have been attractive enough to encourage participants to follow an EMH intervention. Lastly, we offered several fitting EMH interventions to leave room for personal preferences. Most participants had to decide whether they wanted to follow an EMH intervention, but also which one. This might have made the option to not participate more attractive. Although the EMH interventions were only followed by a small number of participants and only to a small extent, we did find positive results. It seems plausible that undergoing screening and receiving personalized online feedback plus tailored advice when needed form an intervention in itself, as it might encourage to think about one s own work functioning and mental health and to seek help if needed. To ensure that healthcare employees stay mentally healthy and well-functioning, preventive strategies should be put in place to identify impaired work functioning or impaired mental health early and to offer tailored support. We recommend setting up and periodically performing WHS for nurses and allied health professionals. If available, occupational health services form a natural platform for WHS. To improve the mental module, we suggest to explore the possibilities of blended care by incorporating guidance by a healthcare provider, to increase compliance and to check whether the EMH intervention is of added value for the specific employee. Additionally, we recommend to adapt the screening to a stepwise method, starting with a general and short screening. The healthcare provider could perform further specific screening (if needed) and provide feedback. Furthermore, more attention is needed to increase the attractiveness of the EMH interventions, e.g. by applying elements of persuasive design. 162

164 Pre-post effects of an e-mental health approach to WHS To conclude, an EMH approach to WHS improves work functioning and mental health of nurses and allied health professionals. However, since effects were small and participation in the EMH interventions was low, there is ample room for improvement

165 CHAPTER 7 REFERENCES 1 McVicar A. Workplace stress in nursing: a literature review. J Adv Nurs 2003; 44: Mealer M, Burnham EL, Goode CJ et al. The prevalence and impact of post traumatic stress disorder and burnout syndrome in nurses. Depress Anxiety 2009; 26: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: Letvak SA, Ruhm CJ, Gupta SN. Nurses presenteeism and its effects on self-reported quality of care and costs. Am J Nurs 2012; 112: International Labour Organization. Technical and ethical guidelines for workers health surveillance. Geneva, Switzerland: ILO, Sluiter JK. High-demand jobs: age-related diversity in work ability? Appl Ergon 2006; 37: Warmerdam L, van Straten A, Twisk J et al. Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res 2008; 10:e44. 8 Riper H, Kramer J, Smit F et al. Web-based self-help for problem drinkers: a pragmatic randomized trial. Addiction 2008; 103: Ketelaar SM, Nieuwenhuijsen K, Gärtner FR et al. Effect of an e-mental health approach to workers health surveillance versus control group on work functioning of hospital employees: a cluster-rct. PLoS One 2013; 8:e Gärtner FR, Ketelaar SM, Smeets O et al. The Mental Work study: design of a randomized controlled trial on the effect of a workers health surveillance mental module for nurses and allied health professionals. BMC Public Health 2011; 11: Bolier L, Haverman M, Kramer J et al. Internet-based intervention to promote mental fitness in mildly depressed adults: design of a randomized controlled trial. JMIR Res Protoc 2012; 1:e2. 12 Strong at Work [in Dutch: Sterk op je werk], Accessed 21 March de Graaf LE, Gerhards SA, Arntz A et al. Clinical effectiveness of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial. Br J Psychiatry 2009; 195: van Ballegooijen W, Riper H, van Straten A et al. The effects of an Internet based self-help course for reducing panic symptoms - Don t Panic Online: study protocol for a randomised controlled trial. Trials 2011; 12: Bolier L, Haverman M, Bohlmeijer E. Psyfit online - Randomized effect study on an online mental fitness self-help program - Internal report [in Dutch: Psyfit online - Gerandomiseerde effectstudie naar een e-mental fitness zelfhulpprogramma - Intern rapport]. Utrecht, the Netherlands: Trimbos-instituut, Spek V, Nyklicek I, Smits N et al. Internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years old: a randomized controlled clinical trial. Psychol Med 2007; 37: Ketelaar SM, Gärtner FR, Bolier L et al. Mental Work - A Workers Health Surveillance mental module for nurses and allied health care professionals: Process evaluation of a randomized controlled trial. J Occup Environ Med 2013; 55: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Psychometric properties of the Nurses Work Functioning Questionnaire (NWFQ). PLoS One 2011; 6:e Terluin B. The Four Dimensional Symptom Questionnaire (4DSQ) [in Dutch: De Vierdimensionele Klachtenlijst (4DKL) in de huisartspraktijk]. De Psycholoog 1998; 33: Terluin B, van Marwijk HW, Ader HJ et al. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry 2006; 6: van Veldhoven M & Meijman T. The measurement of psychosocial job demands with a questionnaire: the questionnaire on the experience and evaluation of work (QEEW) [in Dutch: Het meten van een psychosociale arbeidsbelasting met een vragenlijst: de vragenlijst beleving en beoordeling van arbeid (VBBA)]. Amsterdam, the Netherlands: Dutch Institute for Working Conditions, de Croon EM, Sluiter JK, Frings-Dresen MH. Psychometric properties of the Need for Recovery after work scale: test-retest reliability and sensitivity to detect change. Occup Environ Med 2006; 63:

166 Pre-post effects of an e-mental health approach to WHS 23 Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Interpretability of change in the Nurses Work Functioning Questionnaire: minimal important change and smallest detectable change. J Clin Epidemiol 2012; 65: Cohen J. Statistical power analysis for the behavioral sciences. 2nd edn. Hillsdale, N.J.: Lawrence Erlbaum Associates, van Rhenen W, van Dijk FJ, Schaufeli WB, Blonk RW. Distress or no distress, that s the question: A cutoff point for distress in a working population. J Occup Med Toxicol 2008; 3:3. 26 Broersen JPJ, Fortuin RJ, Dijkstra L et al. Monitor occupational health and safety: key indicators and limits [in Dutch: Monitor Arboconvenanten: kengetallen en grenswaarden]. TBV 2004; 12: Ruitenburg MM, Frings-Dresen MH, Sluiter JK. The prevalence of common mental disorders among hospital physicians and their association with self-reported work ability: a cross-sectional study. BMC Health Serv Res 2012; 12: Lexis MA, Jansen NW, Stevens FC et al. Experience of health complaints and help seeking behavior in employees screened for depressive complaints and risk of future sickness absence. J Occup Rehabil 2010; 20: Codony M, Alonso J, Almansa J et al. Perceived need for mental health care and service use among adults in Western Europe: results of the ESEMeD project. Psychiatr Serv 2009; 60:

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168 8 COMPARATIVE COST-EFFECTIVENESS OF TWO INTERVENTIONS TO PROMOTE WORK FUNCTIONING BY TARGETING MENTAL HEALTH COMPLAINTS AMONG NURSES: PRAGMATIC CLUSTER RANDOMISED TRIAL Cindy Noben Filip Smit Karen Nieuwenhuijsen Sarah Ketelaar Fania Gärtner Brigitte Boon Judith Sluiter Silvia Evers Int J Nurs Stud 2014; 51:

169 CHAPTER 8 ABSTRACT Background: The specific job demands of working in a hospital may place nurses at elevated risk for developing distress, anxiety and depression. Screening followed by referral to early interventions may reduce the incidence of these health problems and promote work functioning. Objective: To evaluate the comparative cost-effectiveness of two strategies to promote work functioning among nurses by reducing symptoms of mental health complaints. Three conditions were compared: the control condition consisted of online screening for mental health problems without feedback about the screening results. The occupational physician condition consisted of screening, feedback and referral to the occupational physician for screen-positive nurses. The third condition included screening, feedback, and referral to e-mental health. Design: The study was designed as an economic evaluation alongside a pragmatic cluster randomised controlled trial with randomisation at hospital-ward level. Setting and participants: The study included 617 nurses in one academic medical centre in the Netherlands. Methods: Treatment response was defined as an improvement on the Nurses Work Functioning Questionnaire of at least 40% between baseline and follow-up. Total perparticipant costs encompassed intervention costs, direct medical and non-medical costs, and indirect costs stemming from lost productivity due to absenteeism and presenteeism. All costs were indexed for the year Results: At 6-months follow-up, significant improvement in work functioning occurred in 20%, 24% and 16% of the participating nurses in the control condition, the occupational physician condition and the e-mental health condition, respectively. In these conditions the total average annualised costs were 1,752, 1,266 and 1,375 per nurse. The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was dominant, suggesting cost savings of 5,049 per treatment responder. The incremental cost-effectiveness ratio for the e-mental health condition versus the control condition was estimated at 4,054 (added costs) per treatment responder. Sensitivity analyses attested to the robustness of these findings. Conclusions: The occupational physician condition resulted in greater treatment responses for less costs relative to the control condition and can therefore be recommended. The e-mental health condition produced less treatment response than the control condition and cannot be recommended as an intervention to improve work functioning among nurses. 168

170 Cost-effectiveness of a mental health module for WHS INTRODUCTION Nurses are at elevated risk for mental distress, anxiety and depression. 1-4 Possible explanations for this increased risk are found in work characteristics such as high job demands and a lack of autonomy. 2,5 Poor mental health is not only undesirable in its own right, but will likely also have an adverse impact on the nurses job functioning and may thus jeopardise the health and safety of the patients in their care. After all, nurses with poor mental health experience significantly more medical errors. 2,6,7 For these reasons it is imperative to protect and promote mental health in nurses, and to monitor and safeguard the quality of their functioning at work. 2 Mental disorders carry substantial disease and economic burdens. Preventive interventions for mental disorders exist; however, what interventions should be financed and implemented is an issue that needs to be addressed by decision makers. Moreover, the number of health-economic evaluations that were conducted in the work setting is very limited. Likewise, information to aid in the transferability of available results to different contexts and settings is limited. 8 Economic evaluations can provide answers, select interventions that are cost-effective and avoid wasting limited resources. An approach to priority setting is largely based on economic techniques to assess the cost-effectiveness to answer questions regarding the economic value for money of competing interventions. 9,10 Periodic screening might be useful to identify nurses with signs of mental health problems and encourage help-seeking behaviour. To that end a Worker Health Surveillance was developed. The Worker Health Surveillance is a preventive strategy that aims at the early detection of negative health effects at work. 2,11,12 A Worker Health Surveillance with personalised feedback and referral to dedicated early interventions for screen positives might be a successful strategy to prevent the onset and further deterioration of mental health problems and to reduce impairments in work functioning. 2,13 In this study we compare a control condition consisting of screening without feedback versus Worker Health Surveillance screening with feedback plus referral for a consultation with an occupational physician or referral to preventive e-mental health interventions. These approaches have not been evaluated from a health-economic perspective. Therefore, the aim of this study is to assess the comparative cost-effectiveness of the occupational physician condition and the e-mental health condition versus the control condition, with a view to protecting mental health and improving and sustaining work functioning in nurses

171 CHAPTER 8 METHODS Design The Mental Work study 14 was designed as a pragmatic cluster randomised controlled trial, with randomisation at the level of hospital wards to three conditions: 1. Screening and feedback followed by referral to the occupational physician for screen-positives (the occupational physician condition). 2. Screening and feedback followed by referral and access to preventive e-mental health interventions (the e-mental health condition). 3. Screening without feedback and without referral to either the occupational physician or the e-mental health interventions (the control condition). Data were recorded at baseline and after three and six months. In the economic evaluation, we assessed the comparative cost-effectiveness in two contrasting scenarios: (1) the occupational physician condition versus the control condition, and (2) the e-mental health condition versus the control condition. A medical ethics committee approved the study. Randomisation Cluster randomisation was performed at the ward level to prevent contamination between participants working in the same ward. A pre-randomisation procedure with incomplete-double-consent design was applied 15,16 meaning that individuals were only informed about their own group. This further minimised the possibility of contamination. Randomisation was conducted using the computer software programme Nquery Advisor in blocks of three wards. After randomisation, 28 wards with 591 employees were assigned to the occupational physician condition, 29 wards with 579 employees to the e-mental health condition, and 29 wards with 561 employees to the control-condition. Sample The study population of the complete trial included all nurses with similar work demands and work conditions; including surgical nurses, anaesthetic nurses, and allied health professionals (henceforth: nurses) working in one Dutch academic medical centre. Nurses who were sick-listed at the start of the study and expected to be on sick leave for more than 2 weeks were excluded from the study. All eligible employees were invited to take part in the study, which for the complete trial added up to 1,731 employees working in 86 wards. Cost-effectiveness analyses were performed according to the intention-to-treat principle for the whole sample. However, participation rates of the nurses in the interventions at baseline were 34% in the control condition; 32% in the occupational physician condition; and 31% in the e-mental health condition. 170

172 Cost-effectiveness of a mental health module for WHS After randomisation, 212 nurses were assigned to the e-mental health condition, 210 to the occupational physician condition and 211 to the control condition. Sixteen nurses (three in the occupational physician condition, eight in the e-mental health condition and five in the control condition) were sick-listed for more than two weeks at the start of the trial, did not contribute to the data and were excluded from the analysis. Thus, the study population comprised a total of 617 nurses: 207 in the occupational physician condition, 204 in the e-mental health condition and 206 in the control condition. Interventions All participants were screened for work functioning impairments and six types of mental health complaints: distress, work-related fatigue, risky drinking, depression, anxiety, and post-traumatic stress disorder. Nurses in the control condition filled out the questionnaires and no further steps were taken. After completing the screening, the occupational physician condition and the e-mental health condition immediately received personalised feedback about their screening results. In the occupational physician condition, screening and feedback were followed by an invitation for the screen-positives to attend the occupational physician. The nurses consulted the occupational physician or not at their own discretion. In order to structure the consultation of the occupational physician, a seven-step protocol was applied, with the focus on identifying impairments in work functioning and providing advice on how to improve wellbeing and work functioning. In the e-mental health condition, screening and feedback were followed by referral to e-mental health interventions. The e-mental health interventions offered in the e-mental health condition were Psyfit, aimed at promoting mental fitness and wellbeing; Strong at Work, aimed at learning skills to cope better with work-related stress; Colour your Life, for coping with depressive symptoms; Don t Panic Online, to reduce symptoms of panic disorder; and Drinking Less, aimed at reducing risky alcohol consumption. Nurses who screened positive on one of these health problems were offered access to the corresponding e-mental health intervention. Nurses screening negative on mental health complaints, but positive on work functioning impairments were offered Psyfit and an onscreen psycho-educational leaflet about dealing with these impairments. Nurses screening negative on both mental health complaints and on work functioning impairments were only offered free access to Psyfit. The onscreen psycho-educational leaflet was also offered when nurses screened positive on mental health complaints and on work functioning impairments. In any case, making use of the e-mental health interventions was strictly voluntary and nurses were free to reject the offer of using the interventions

173 CHAPTER 8 Outcome measure The primary outcome was work functioning as measured by the following subscales of the Nurses Work Functioning Questionnaire: cognitive aspects of task execution, causing incidents at work, avoidance behaviour, conflicts and irritations with colleagues, impaired contact with patients and their family, lack of energy and motivation. The Nurses Work Functioning Questionnaire is a 50-item self-report questionnaire with Likert-type response scales ranging from 0 (totally disagree) to 6 (totally agree); 0 (disagree) to 4 (agree); and 0 (no difficulty) to 6 (great difficulty). 11 Internal reliability of the Nurses Work Functioning Questionnaire is high, with Cronbach s alphas varying between 0.70 and The difference between the occupational physician condition and the e-mental health condition versus the control condition was examined as the percentage of individuals who improved at follow-up. The primary outcome of work functioning is operationalised as job-specific impairments in work functioning and were measured using a total score of the Nurses Work Functioning Questionnaire. The minimal important change value for improvement was based on the relative pre-post change scores, that is (T 0 T 1 / T 0 ) 100%, indicating the percentage of change on impaired work functioning in relation to the baseline score. Individuals with a relative improvement on their Nurses Work Functioning Questionnaire total score of 40% or more, 18 which is the minimal important change (MIC) value, were defined as relevantly improved, and henceforth denoted as treatment responders. Resource use and costing Resource usage and costs entailed can be split into a) intervention costs; b) direct medical costs (due to health service uptake and pharmacy use); c) direct non-medical costs (the nurses out-of-pocket costs for travel and parking, incurred while making use of health services); and d) indirect costs stemming from lost productivity in paid work due to absenteeism and presenteeism. All costs were in euro indexed for the reference year 2011 based on the price indices from Statistics Netherlands. 19 Intervention costs When calculating the intervention costs, a distinction was made between human and material resources. Material resources are divided into capital items that have a time span longer than one year, such as the equipment that was needed to build the screening module for the provision of the feedback and the interventions, and recurrent or revenue items that are consumed in less than one year, such as maintenance costs. For human resources, costs were based on the valuation of the personnel involved in the development and the application of the intervention. The corresponding calculations for the intervention costs can be obtained from the first author. 172

174 Cost-effectiveness of a mental health module for WHS The per-participant costs for the online Worker Health Surveillance were estimated to be The costs of the occupational physician intervention consisted of the per-participant screening costs of 3.80 plus the costs of the occupational physician at per contact. For the e-mental health intervention, the per-participant costs were the screening costs of 3.80 plus the costs of the specific e-mental health interventions. The costs of the e-mental health interventions were only charged when a participant logged in to an e-mental health intervention and thus became a user of that intervention. The e-mental health interventions have fixed per-participant cost prices that are based on their market values, which are subject to change over time. In the reference year of 2011, the per-user costs were as follows: Psyfit 30, Strong at Work 175, Colour your Life 195, Don t Panic Online 225 and Drinking Less 45. Direct medical costs Health service costs were calculated by multiplying the health service units (contact, session, hour) with their standard full economic cost price. The standard costs were reported in the Dutch guideline for health economic evaluations 20 and indexed for the year 2011 using the consumer price index from Statistics Netherlands. 19 The costs of prescription drugs were calculated as the price per standard daily dose as reported in Dutch guidelines and multiplied by the number of days. 21 The pharmacist s dispensing costs of 5.99 and the general practitioners prescription costs of 14 were added. 20 Over the counter drugs were based on their market prices. Direct non-medical costs The participants travel and parking expenses incurred in receiving professional help were computed as the distance to a health service multiplied by the costs per kilometre ( 0.21), with parking costs ( 3 per hour) added. 20 Indirect non-medical costs Finally, the costs stemming from production losses in paid work were calculated from the number of days absent from work (absenteeism) plus the number of workdays lost due to work cutback (presenteeism). Presenteeism was calculated by correcting for the degree of inefficiency, resulting in an inefficiency score used as point prevalence for the calculation of presenteeism costs. The inefficiency score for work quantity and work quality derived from items from the Productivity and Disease Questionnaire (ranging from 0 to 1, with 0 meaning not inefficient and 1 completely inefficient) was multiplied by the number of days at work while not feeling well in order to compute the costs of presenteeism The valuation method for productivity is rooted in the human capital theory whereby the production losses are assumed to equal the present value of all lost future earnings of the individual. That is, income (before tax) acts as a proxy for the production value of that 173

175 CHAPTER 8 individual and encompasses all productivity losses by this person. 23,24 The costs of productivity losses were then assessed by multiplying the number of workdays lost by the gender and age-specific productivity levels per paid employee, indexed for the year ,20 Analyses All analyses were performed in agreement with the intention-to-treat principle, thus including all participants as randomised. To that end, missing data were imputed. Since substantial dropout had occurred, sensitivity analyses were conducted to gauge the robustness of our findings across different imputation techniques. In the main analysis, missing data were replaced by their most likely value under the expectation maximisation algorithm in SPSS 19. In one sensitivity analysis, all analyses were repeated with last observation carried forward, as implemented in SPSS. In yet another sensitivity analysis, regression imputation as implemented in Stata (version 12.1) was used to impute missing data. As predictor variables we used baseline costs, baseline work functioning, age, gender, partner status and the Karasek factors job demands, control, support from colleagues and superiors. 25,26 Directing the sensitivity analyses towards the various imputation strategies was an a priori decision, because it was imperative to ascertain that the research findings did not solely hinge on the chosen imputation technique. The cost-effectiveness analysis was conducted from the societal perspective in which all costs and benefits were included, irrespective of who bears the costs or receives the benefits. 9 Both the incremental costs and incremental effects were used to calculate the incremental cost-effectiveness ratio. The incremental cost-effectiveness ratio was calculated as (C 1 C 0 )/(E 1 E 0 ), where C denotes the average per-participant costs and E is the effect in the experimental and control conditions (subscripted 1 and 0, respectively). The incremental cost-effectiveness ratio can be interpreted as the net costs (or savings) per treatment responder. To handle stochastic uncertainty in the cost and effect data, non-parametric bootstraps were used to simulate 5,000 incremental cost-effectiveness ratios. The incremental cost-effectiveness ratios were plotted on the cost-effectiveness plane to capture the uncertainty in the incremental cost-effectiveness estimate (see Figure 2). To be more precise, each simulated incremental cost-effectiveness ratio can be plotted on one of the four quadrants of the incremental cost-effectiveness plane. In the North East quadrant the intervention produces superior health gains at additional costs relative to the control condition. In the North West quadrant less health is produced for additional costs. Clearly, this is the worst possible outcome, and the intervention is then dominated by the control condition. In the South West quadrant less health is produced, but there are cost savings. Finally, in the South East quadrant the intervention generates superior health gains 174

176 Cost-effectiveness of a mental health module for WHS (relative to the comparator condition) and does so for lower costs. This is the best possible outcome and the intervention is then said to dominate the control condition. It is often seen that a new intervention falls in the North East quadrant, because better health is obtained for additional costs. RESULTS Sample characteristics Baseline characteristics of the groups are shown in Table 1. There were no differences across the conditions in terms of demographics, baseline costs and work functioning. Therefore we concluded that randomisation had resulted in a balanced trial. Table 1 Sample characteristics by condition at baseline. Control condition (n = 206) Occupational physician condition (n = 207) E-mental health condition (n = 204) Age, mean (sd) 42 (11.3) 43 (11.4) 38 (12.2) Female, N (%) 159 (77.2) 170 (82.1) 169 (82.8) Working hours, mean (sd) 31 (6.0) 29 (8.0) 31 (5.2) Living with a partner, N (%) 154 (74.8) 153 (73.9) 151 (74.0) Born in the Netherlands, N (%) 176 (85.4) 167 (80.7) 174 (85.3) Work experience, years (sd) 11 (10.1) 13 (10.4) 10 (10.0) Turnover intention, N (%) 22 (10.7) 27 (13.0) 25 (12.3) Baseline costs, a mean (sd) Medication costs 1 (7) 2 (19) 2 (11) Health care service use 117 (229) 122 (239) 212 (1,090) Absenteeism 492 (1,689) 660 (2,110) 377 (856) Presenteeism 1,069 (1,863) 1,125 (2,429) 974 (1,541) Direct non-medical costs 11 (20) 11 (20) 20 (105) Work functioning, mean (sd) 14 (9.5) 13 (9.2) 13 (9.2) a In, time horizon of baseline costs was 3 months. Missing data and dropout At baseline, data on impaired work functioning were missing for 11/206 (5%) participants in the control condition, 10/207 (5%) in the occupational physician condition and 15/204 (7%) in the e-mental health condition. At 3-months follow-up, the dropout rates in the control condition, the occupational physician condition and the e-mental health condition 8 175

177 CHAPTER 8 were 61 (30%), 77 (37%) and 121 (59%), respectively. At 6-months follow-up, dropout rates had increased to 68 (33%), 94 (45%), 133 (65%). The flow of the participants through the trial is shown in Figure 1. Since loss to follow-up was substantial, we assessed if dropout was selective. A dropout dummy variable (1 = lost, 0 = retained) was computed and regressed on condition, baseline costs, baseline work functioning, age, gender, partner status, and the Karasek Randomisation of wards to study arm 1, 2 or 3 (wards: N = 86; employees: N = 1,731) Study arm 1: Control group (N = 561, 28 wards) Study arm 2: OP-care group (N = 591, 29 wards) Study arm 3: EMH-care group (N = 579, 29 wards) 211 started baseline questionnaire 210 started baseline questionnaire 212 started baseline questionnaire Exclusion (N = 5) Exclusion (N = 3) Exclusion (N = 8) 206 included for economic analysis 207 included for economic analysis 204 included for economic analysis 195 completed baseline (206 analysed) 197 completed baseline (207 analysed) 189 completed baseline (204 analysed) 145 completed 3-months follow-up (206 analysed) 130 completed 3-months follow-up (207 analysed) 83 completed 3-months follow-up (204 analysed) 138 completed 6-months follow-up (206 analysed) 113 completed 6-months follow-up (207 analysed) 71 completed 6-months follow-up (204 analysed) Figure 1 Participants flow through the study. 176

178 Cost-effectiveness of a mental health module for WHS factors (job demands, control, support by colleagues and superiors). 25,26 The analyses indicated that the occupational physician condition was associated with higher dropout than the control condition, and that poorer work functioning at baseline increased the risk of dropout, but having a partner was associated with a smaller likelihood for dropout. When comparing the e-mental health condition to the control condition, it was shown that the e-mental health condition was associated with greater dropout, as were poorer work functioning and higher job demands at baseline. Again, living together with a partner was associated with a reduced likelihood of dropping out. Health care service use The most frequently used health care services among all three conditions were the physiotherapist and GP services. At 3-months follow-up, consulting the occupational physician increased only in the occupational physician condition, most likely due to the intervention in which these visits were encouraged. Interestingly, the occupational physician condition visits showed a substantial decrease at 6-months follow-up. After six months a reduction in the average volumes of physiotherapist and GP visits is noticeable in all three conditions. Also, use of prescription drugs decreased over time in the three groups. Supplementary Table 1 lists the average volumes of resource use by treatment group and time (see Appendix 1). Incremental cost-effectiveness Costs Table 2 presents the costs of health care uptake and the costs stemming from productivity losses by condition and time point. The most significant costs can be attributed to the productivity losses. In particular, the costs of presenteeism increased in the control condition between baseline and 6-months follow-up, but decreased in the occupational physician condition and the e-mental health condition. Incremental costs Table 3 (upper panel) shows the costs per condition. The average total costs were calculated to be 1,266 per participant in the occupational physician condition and 1,752 in the control condition. The incremental costs were therefore 1,266 1,752 = 486 per-participant (negative costs, hence a cost reduction). The incremental costs for the e-mental health condition were associated with a decrease in costs compared to the control condition: 1,375 1,752 =

179 CHAPTER 8 Table 2 Mean per-participant costs by condition and measurement (in ). Baseline 3 months 6 months Control (n = 204) Occupational physician (n = 206) E-mental health (n = 204) Control (n = 148) Occupational physician (n = 132) E-mental health (n = 89) Control (n = 140) Occupational physician (n = 115) E-mental health (n = 73) Direct medical costs Service use Medication Indirect non-medical costs Absenteeism Presenteeism 1,069 1, , , ,016 Direct non-medical costs

180 Cost-effectiveness of a mental health module for WHS Table 3 Summary statistics for each of the interventions under each imputation technique. South West South East (dominant) Costs, a Effect b ICER, c North East North West (inferior) Base-case scenario (Expectation maximisation) Control 1, Occupational physician 1, Dominant d 2% 1% 21% 75% E-mental health 1, ,054 1% 8% 76% 16% Alternative scenario A (Last observation carried forward) Control 1, Occupational physician 1, Dominant d 10% 2% 9% 80% E-mental health 1, ,303 1% 5% 75% 18% Alternative scenario B (Regression) Control 1, Occupational physician 1, Dominant d 1% 0% 17% 81% E-mental health 1, ,022 1% 8% 74% 16% a Cost per treatment responder at 2011 prices. b Fraction treatment responders (differences in effect estimates in the text and the table are due to rounding). c The presented median ICER is 50th percentile of 5,000 bootstrap replications of the ICER. d When the ICERs are negative (suggesting cost savings) then they are labelled as dominant, representing a situation where the intervention is superior to the control condition from a cost-effectiveness perspective

181 CHAPTER 8 Incremental effects Table 3 (upper panel) shows the effects per condition. At follow-up, 49/207 = 23.7% of the participating nurses met criteria for treatment response in the occupational physician condition compared with 45/206 = 20.4% in the control condition. In the e-mental health condition, this was 23/204 = 15.7%. The incremental effectiveness between the occupational physician condition and the control condition was therefore = This was = for the e-mental health condition versus the control condition. ICER occupational physician condition versus control condition As noted for the occupational physician condition, the incremental costs were 486 (savings) and the incremental effect was We rely on the median incremental costeffectiveness ratio (ICER) as estimated from the 5,000 non-parametric bootstraps. The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was estimated as a saving of 5,049 per treatment responder. Figure 2a shows the scatter of bootstrapped incremental cost-effectiveness ratios on the incremental cost-effectiveness plane. Of the 5,000 simulated incremental cost-effectiveness ratios, 75% fall into the South East-quadrant, indicating that more treatment responses are generated for fewer costs by the occupational physician intervention relative to the control condition. Another 2% of the simulated incremental cost-effectiveness ratios fall in the North East-quadrant, indicating a probability of 2% that by applying the intervention an additional treatment response is produced, but at additional costs. The remainder of the stimulated incremental cost-effectiveness ratios showed up on the west side of the plane, indicating less effectiveness and less costs (21%), or less effectiveness and more costs (1%). In sum, the occupational physician condition is associated with a 75% probability that the intervention generates better outcomes for less money than the control condition. ICER e-mental health condition versus control condition As noted, in the e-mental health condition the incremental costs were 377 (negative costs, hence a cost saving), but the incremental effect was (a small loss in effectiveness) relative to the control condition. The median incremental cost-effectiveness ratio could be estimated as 4,054. Figure 2b shows that 76% of the simulated incremental cost-effectiveness ratios fall in the South West-quadrant indicating a probability of 76% that by applying the e-mental health condition fewer treatment responses are produced, albeit at less additional costs. Another 16% of the simulated incremental cost-effectiveness ratios fell into the South East-quadrant, indicating that more treatment responses are generated for less additional costs by the e-mental health condition relative to the control condition. Finally, 1% indicates more effects at higher costs and 8% indicates less effect at higher costs. 180

182 Cost-effectiveness of a mental health module for WHS Sensitivity analysis Sensitivity analyses were conducted by repeating all analyses under two alternative imputation strategies: using last observation carried forward imputation (in SPSS 19) and under regression imputation (in Stata 12.1). Table 3 (lower panels) presents the summary statistics of the sensitivity analyses. As can be seen, the findings that were obtained under expectation maximisation imputation are consistent with the results produced under last observation carried forward and regression imputation. In fact, the results obtained under expectation maximisation imputation fall between last observation carried forward and regression imputation. a) OP versus CTR under EM imputation b) EMH versus CTR under EM imputation 1,000 less effective/ more expensive 1% 500 more effective/ more expensive 2% less effective/ more expensive 8% more effective/ more expensive 1% Additional costs ,000 Additional costs ,000 less effective/ less expensive 21% -1,500 more effective/ less expensive 75% less effective/ less expensive 76% -1,200 more effective/ less expensive 16% Additional effects Additional effects Figure 2 Scatter of simulated incremental cost-effectiveness ratios (n = 5,000) on the cost-effectiveness plane. a) OP versus CTR under EM imputation; b) EMH versus CTR under EM imputation

183 CHAPTER 8 DISCUSSION Main findings This study was conducted to assess the cost-effectiveness of two strategies (the occupational physician condition and the e-mental health condition) to improve work functioning compared to the control condition of screening alone. The proportion of participants that manifested with a reliable change in work functioning was higher, although non-significant, in the occupational physician condition: 23.7% against 20.4% in the control condition. The proportion of improved participants on work functioning in the e-mental health condition on the other hand was lower: 15.7% against 20.4% in the control condition. The average per-responder costs in the three conditions were 1,266 in the occupational physician condition, 1,375 in the e-mental health condition and 1,752 in the control condition. The median incremental cost-effectiveness ratio in the occupational physician condition versus the control condition comparison is dominant ( 5,049), hence a cost-saving per treatment responder. Therefore, the occupational physician condition can be recommended over the control condition, because the occupational physician condition is associated with a greater likelihood that beneficial effects are obtained for fewer costs. The median incremental cost-effectiveness ratio in the e-mental health condition versus the control condition comparison is 4,054 per treatment responder. The e-mental health intervention does not outperform the control condition, because the odds are that nurses derive fewer benefits from this intervention. Sensitivity analyses attested to the robustness of these findings. Strengths and limitations Some of the strengths of this study are its randomised design and its relatively large sample size. This is worth mentioning, because the literature identifies several barriers to conducting randomised trials within the work setting such as the difficulties encountered when randomising employees while also trying to avoid the risk of contamination The design with cluster randomisation and pre-randomisation was a strength of this study because randomisation at the ward level reduces the contamination of study groups. Furthermore, pre-randomisation allowed the participants to be blinded with respect to the information related to the other study groups. This minimised contamination effect in the study. Next, in an attempt to tie the results of this study to previous research, wherein a lack of economic workplace mental health promotion studies is prevailing, 8,31 this mental health 182

184 Cost-effectiveness of a mental health module for WHS oriented intervention for nurses can be seen as a welcome addition to the literature strengthening the evidence base. The findings of this study need to be placed in the context of the study s limitations. First, the trial suffered from dropout, and our own analysis indicated that dropout had not occurred randomly. Unfortunately we do not have data on reasons for non-responding to the interventions. However, we can speculate that the main reason for drop-out in this specific study population might be feelings of work overload and the inability to find the time to improve their self-management skills. Again, this remains speculative but might have distorted the findings. However, we conducted intention-to-treat analysis using expectation maximisation imputation to handle missing data. In addition, sensitivity analyses were conducted with different imputation techniques and these attested to the robustness of our findings. Second, the follow-up period used in this trial was short and we do not know what the cost-effectiveness of the interventions would look like beyond six months. Third, the per-participant intervention costs were partly based on assumptions. In particular, the assumption about the number of nurses that would engage in the online screening was important, because the number of participants affects economies-of-scale and ultimately determines the costs of online screening. It should be mentioned that whenever we had to make an assumption, we preferred to err on the conservative side, thus making a conscious choice to steer away from sketching too positive a picture of the cost-effectiveness of the interventions. It should also be noted that the costs for screening are low anyway and are therefore unlikely to have a substantial impact on the outcomes overall. Fourth, the study s results are inevitably conditional on the central clinical end-point: work functioning. This was an a priori choice, but is also a limitation, because in this economic evaluation we did not report on secondary outcomes such as mental wellbeing, changes in symptom level of mental distress and so forth. Had we chosen other outcomes, we would have drawn different conclusions, because the nurses manifested with favourable response on some of these outcomes, even when they did not manifest with treatment response on work functioning. Thus, when we say that the e-mental health intervention is not to be recommended, we say this only with respect to work functioning and our recommendations cannot be generalised towards other outcomes. 8 Fifth, the measurements of work functioning were based on self-report and this may have biased outcomes. However, it is difficult to say if this might have led to an upward or downward bias. Moreover, we are looking at relative change in work functioning over 183

185 CHAPTER 8 time and this may have cancelled out a constant bias in participants to exaggerate or diminish the level of their work functioning, while randomisation may have counteracted bias across conditions. Sixth, it should be noted that all costs are computed for a situation in which the interventions have been fully implemented. Thus the initial investment required to implement the interventions is not part of our study. This was done in agreement with guidelines for economic evaluations, 9,20,23 but we recognise that the costs required for implementing the interventions might be interesting in their own right. Estimates of these costs can therefore be obtained from the first author. Seventh, although we complied with the guidelines for pharmaco economic evaluations carried out from the societal perspective whereby direct and indirect costs, inside and outside the healthcare system were included, we acknowledge the possibility of missing costs that might influence the results. Potentially, medical costs which may arise during life-years gained as a result of the treatment are lacking in this study. However, due to the preventive nature of the intervention, it is rather unlikely that these indirect costs within the health care system influence the cost-effectiveness results in a substantial manner. Finally, this study was designed as a pragmatic trial that was conducted in the real-life context of one large academic medical centre in the Netherlands. The strength of this approach is that the trial has a good ecological (external) validity; 32 its weakness is that the outcomes cannot be interpreted as evidence of the interventions efficacy only of the interventions effectiveness under real-life conditions. The hospital in which this study was performed is an academic medical centre. Therefore, the findings are best generalised towards other teaching hospitals, while some caution must be applied when projecting the study s outcomes on hospitals that are not embedded in a university. In this context, it is important to note that the nurses were under constant pressure from their professional obligations and were free to make use of the interventions offered. We see that uptake rates and compliance rates are low, especially regarding the e-mental health interventions. While this may strengthen the level of realism of the trial s outcomes, the outcomes can now not be read as evidence for or against the efficacy of the interventions and are likely to differ from estimates that would have been obtained under tightly controlled conditions. Recommendations For improving work functioning in nurses, we recommend implementing the occupational physician condition over the control condition, because the occupational physician condition is associated with better outcomes and cost savings. However, we must be careful recommending for or against implementing the e-mental health condition, 184

186 Cost-effectiveness of a mental health module for WHS because it is associated with a smaller likelihood of producing beneficial effects albeit for lesser costs than the control condition. We also note that had the e-mental health intervention been embedded more rigorously in the work setting, then uptake rates might have looked very different and the e-mental health condition might have yielded more favourable outcomes. At any rate, we recommend that e-health interventions be more fully integrated in the organisation before testing their effectiveness. These recommendations need to be viewed with some caution, because the economic evaluation was conducted with the specific, perhaps somewhat narrow, aim of improving work functioning. Moreover, the outcome was based on self-report, was extended over a brief follow-up period of six months, and was measured in the context of substantial, possibly selective, drop-out

187 CHAPTER 8 REFERENCES 1 Campo MA, Weiser S, Koenig KL. Job strain in physical therapists. Phys Ther 2009; 89: Gärtner FR, Nieuwenhuijsen K, Van Dijk FJ, Sluiter JK. The impact of common mental disorders on the work functioning of nurses and allied health professionals: a systematic review. Int J Nurs Stud 2010; 47: Magnavita N & Heponiemi T. Violence towards health care workers in a Public Health Care Facility in Italy: a repeated cross-sectional study. BMC Health Serv Res 2012; 12: Suresh P, Matthews A, Coyne I. Stress and stressors in the clinical environment: a comparative study of fourth-year student nurses and newly qualified general nurses in Ireland. J Clin Nurs 2013; 22: Tayler CM. Subordinate performance appraisal: what nurses really want in their managers. Can J Nurs Adm 1992; 5: Karsh BT, Holden RJ, Alper SJ, Or CK. A human factors engineering paradigm for patient safety: designing to support the performance of the healthcare professional. Qual Saf Health Care 2006; 15 Suppl 1:i59-i65. 7 Suzuki K, Ohida T, Kaneita Y et al. Mental health status, shift work, and occupational accidents among hospital nurses in Japan. J Occup Health 2004; 46: Zechmeister I, Kilian R, McDaid D. Is it worth investing in mental health promotion and prevention of mental illness? A systematic review of the evidence from economic evaluations. BMC Public Health 2008; 8:20. 9 Drummond M, Brandt A, Luce B, Rovira J. Standardizing methodologies for economic evaluation in health care. Practice, problems, and potential. Int J Technol Assess Health Care 1993; 9: Tompa E, Dolinschi R, De Oliveira C. Practice and potential of economic evaluation of workplace-based interventions for occupational health and safety. J Occup Rehabil 2006; 16: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: ILO. Technical and ethical guidelines for workers health surveillance. Scand J Work Environ Health 1998; 24: Koh D & Aw TC. Surveillance in occupational health. Occup Environ Med 2003; 60: Gärtner FR, Ketelaar SM, Smeets O et al. The Mental Work study: design of a randomized controlled trial on the effect of a workers health surveillance mental module for nurses and allied health professionals. BMC Public Health 2011; 11: Schellings R, Kessels AG, Sturmans F. Pre-randomisation in study designs: getting past the taboo [in Dutch: Prerandomisatie bij wetenschappelijk onderzoek: een taboe doorbroken]. Ned Tijdschr Geneeskd 2008; 152: Schellings R, Kessels AG, ter Riet G et al. Indications and requirements for the use of prerandomization. J Clin Epidemiol 2009; 62: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Psychometric properties of the Nurses Work Functioning Questionnaire (NWFQ). PLoS One 2011; 6:e Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Interpretability of change in the Nurses Work Functioning Questionnaire: minimal important change and smallest detectable change. J Clin Epidemiol 2012; 65: CBS (Centraal Bureau voor de Statistiek), L&PA=71311NED&D1=0,2,4,6&D2=0-1,61,70,87,108,137,145,172,176, ,230,255,l&D3=(l-34)- l&hd= &hdr=t&stb=g1,g2. Accessed September Hakkaart L, Tan SS, Bouwmans, CAM. Manual for cost research. Methods and standards costs for economic evaluations in healthcare [in Dutch: Handleiding voor kostenonderzoek. Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg]. Rotterdam, the Netherlands: Instituut voor Medical Technology Assessment, Erasmus Universiteit Rotterdam, CVZ, Farmacotherapeutisch Kompas. Accessed September Koopmanschap MA. PRODISQ: a modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res 2005; 5: Krol M, Papenburg J, Koopmanschap M, Brouwer W Do productivity costs matter?: the impact of including productivity costs on the incremental costs of interventions targeted at depressive disorders. PharmacoEconomics 2005; 29:

188 Cost-effectiveness of a mental health module for WHS 24 Weisbrod BA. The Valuation of Human Capital. J Polit Econ 1961; 69: Karasek R, Baker D, Marxer F et al. Job decision latitude, job demands, and cardiovascular disease: a prospective study of Swedish men. Am J Public Health 1981; 71: Karasek R, Choi B, Ostergren P-O et al. Testing two methods to create comparable scale scores between the Job Content Questionnaire (JCQ) and JCQ-like questionnaires in the European JACE study. Int J Behav Med 2007; 14: Chapman R & Combs S. Collaboration in the Emergency Department: an innovative approach. Accid Emerg Nurs 2005; 13: Chapman R, Duggan R, Combs S. Leading Change and Advancing Health by Enhancing Nurses and Midwives Knowledge, Ability and Confidence to Conduct Research through a Clinical Scholar Program in Western Australia. ISRN Nurs 2011; 2011: Chau JP, Lopez V, Thompson DR. A survey of Hong Kong nurses perceptions of barriers to and facilitators of research utilization. Res Nurs Health 2008; 31: Kajermo KN, Unden M, Gardulf A et al. Predictors of nurses perceptions of barriers to research utilization. J Nurs Manag 2008; 16: Mihalopoulos C, Vos T, Pirkis J, Carter R. The economic analysis of prevention in mental health programs. Annu Rev Clin Psychol 2011; 7: Ramsey S, Willke R, Briggs A et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health 2005; 8:

189 CHAPTER 8 APPENDIX 1 Supplementary Table 1 Average volumes of cost items by condition over time. Baseline 3 months 6 months Services, N (%) CTR (n = 204) OP (n = 206) EMH (n = 204) CTR (n = 148) OP (n = 132) EMH (n = 89) CTR (n = 140) OP (n = 115) EMH (n = 73) Psychologist 11 (5) 10 (5) 15 (7) 11 (7) 8 (6) 2 (2) 10 (7) 3 (3) 3 (4) Psychiatrist 3 (1) 1 (<1) 3 (1) 1 (1) 1 (1) 1 (1) 2 (1) 2 (2) 0 (0) GP 70 (34) 73 (35) 78 (38) 45 (30) 41 (31) 28 (31) 46 (33) 29 (25) 20 (27) OP 14 (7) 21 (10) 13 (6) 8 (5) 25 (19) 6 (7) 8 (6) 4 (3) 4 (5) Physiotherapist 24 (12) 30 (15) 34 (17) 17 (11) 20 (15) 15 (17) 16 (11) 12 (10) 11 (15) Coach 12 (6) 10 (5) 4 (2) 9 (6) 6 (5) 5 (6) 8 (6) 4 (3) 4 (5) Company Social Worker 1 (<1) 2 (1) 4 (2) 5 (3) 1 (1) 1 (1) 2 (1) 2 (2) 0 (0) Social Worker 2 (1) 1 (<1) 3 (1) 3 (2) 1 (1) 0 (0) 3 (2) 2 (2) 0 (0) Spiritual counsellor 2 (1) 1 (<1) 0 (0) 1 (1) 2 (2) 1 (1) 1 (1) 2 (2) 2 (3) Alternative treatment 10 (5) 10 (5) 18 (9) 7 (5) 6 (5) 4 (4) 9 (6) 9 (8) 4 (5) Medication a 15 (7) 10 (5) 13 (6) 8 (5) 6 (5) 7 (8) 5 (4) 7 (6) 3 (4) a All types of medication are included. 188

190 8

191

192 9 GENERAL DISCUSSION

193

194 General discussion How can healthcare professionals be supported to stay healthy and well-functioning at work? That is the topic of this thesis. Its main objectives were to assess novice nurses needs for occupational health support and to evaluate two approaches to a mental health module for job-specific workers health surveillance for nurses and allied health professionals. In this chapter, the main findings are presented. Subsequently, methodological considerations of the research are discussed and the findings are interpreted. In closing, recommendations for practice and research are made. MAIN FINDINGS 1. What are the occupational health support needs of novice nurses to keep them healthy and well-functioning in their (future) work? Using a qualitative study design, 14 nursing students and newly qualified nurses were asked about their needs regarding occupational health support (Chapter 2). Findings indicated that novice nurses already experience work-related health problems early in their career. Reported causes were physical work demands, disagreeable contact with others, having to do a lot of work in a limited time, accidents with biological material and otherwise being exposed to infectious diseases, working shifts, and making mistakes. These risk factors were reported to cause health problems such as musculoskeletal problems, stress and worrying, anxiety, fatigue, sleeping problems, and infectious diseases. Participants also described experiences with how health problems lead to suboptimal work functioning. Reported occupational health support needs were knowledge and psychosocial support during nursing education and at the start of a novice nurse s clinical placement or new job. Also, novice nurses reported a need for sufficient knowledge and support to deal with psychosocial and physical job demands, throughout a nurse s career. 2. How do nurses, allied health professionals and occupational physicians evaluate a mental health module for workers health surveillance? The design of the randomised controlled trial studying two approaches to workers health surveillance (WHS) targeting work functioning and mental health was described in Chapter 3. At baseline, 32% of 1,731 invited nurses and allied health professionals participated in the randomised controlled trial. The process evaluation alongside the randomised controlled trial (Chapter 4) showed that 16% of all participants in the e-mental health (EMH) approach group logged into an EMH intervention and 5% started following it, at least to some extent. The advice on improving work functioning, given in an on-screen educational leaflet, was followed by 23% of the participants who received it. In the occupational physician (OP) approach group, of the participants who received an invitation for a preventive consultation with their occupational physician, 41% came to the 9 193

195 CHAPTER 9 preventive consultation and 80% followed the occupational physician s advice if this was given. Seventeen percent (EMH approach) and 13% (OP approach) of participants would rather receive the personalised feedback on their screening results differently in the future. The occupational physicians who provided the preventive consultations rated that 70-80% of the participants who came to the consultation felt that the personalised feedback reflected their work functioning and mental health. Moreover, of the participants who came to the consultation, almost everyone felt that they could be open and honest with their occupational physician. The preventive consultation was perceived effective by nine of the 15 participants who responded to this question. In both groups, most participants would appreciate to be offered a WHS in the future. The adherence of occupational physicians to the consultation protocol was high, since all steps of the protocol were followed in most of the consultations. The occupational physicians were satisfied with the consultation protocol and training and felt that the preventive consultations had been meaningful. They also considered it to be meaningful to implement a WHS mental health module in the future. 3. What is the effect of an e-mental health approach to workers health surveillance on the work functioning and mental health of nurses and allied health professionals? Around 80% of participants in the randomised controlled trial screened positive for at least mild impairments in work functioning and/or mental health. When comparing the EMH approach to the more conventional OP approach (Chapter 5), both groups improved over time regarding impaired work functioning. Also, a considerable percentage of participants in both groups improved relevantly regarding work functioning (after three months: EMH 30% vs OP 46%; after six months: EMH 36% vs OP 41%). Regarding distress, work-related fatigue and posttraumatic stress, both groups also improved over time. No statistically significant differences were found between the effects of the EMH approach and the OP approach on impaired work functioning, distress, work-related fatigue, posttraumatic stress and work ability. Differences between the two approaches did not exceed the pre-defined criterion of >10 points on work functioning, indicating non-inferiority of the EMH approach compared to the OP approach. However, the OP approach group trended towards better performance. The EMH approach to a mental health module for WHS was also compared to a control group in which participants filled out the screening questionnaire (which was also the baseline questionnaire), but did not receive screening results and advice or access to interventions (Chapter 6). This evaluation showed no significant improvement in the EMH approach group regarding impaired work functioning, distress, work-related fatigue, posttraumatic stress, and work ability to a larger extent than a control group. Both the EMH approach group and the control group improved over time on work functioning, 194

196 General discussion distress, work-related fatigue, and posttraumatic stress, with no statistically significant difference between the groups. When including all participants in the analyses and not only those who had screened positive on impairments at baseline, the work functioning of the EMH approach group further improved between three and six months after baseline while this was not the case in the control group. After three months, a relevant improvement of work functioning was found for 30% of positively screened participants in both groups, while after six months a relevant improvement of work functioning was found for 36% of EMH approach participants and 28% of control group participants (non-significant difference). The control group in the randomised controlled trial was a waiting-list group and control group participants received the EMH approach to a mental health module for WHS after completion of the trial. This meant that their follow-up questionnaire after six months formed the screening questionnaire for their intervention. This design enabled combining data of the original EMH group and the original control group, to enlarge the group of participants who participated in the EMH approach. The effects were studied in full-participating nurses and allied health professionals, i.e. those who participated in the pretest as well as the posttest. By doing so, we were able to increase our certainty about the full-participation effects of the EMH approach to WHS on several outcomes. Evaluating this effect of the EMH approach using a pretest-posttest design (Chapter 7) showed that it led to a statistically significant improvement of work functioning and work-related fatigue over time. In addition, for participants who had logged onto an EMH intervention, the approach had a small meaningful positive effect on distress. 4. What is the cost-effectiveness regarding work functioning of two different approaches to a mental health module for workers health surveillance? The cost-effectiveness regarding work functioning of the EMH approach and the OP approach compared to the control group as evaluated alongside the randomised controlled trial (Chapter 8) showed that the median incremental cost-effectiveness ratio in the EMH approach group versus the control group was 4,054 per treatment responder, implying higher costs per treatment responder. The EMH approach was associated with a high probability of fewer benefits compared to the control group, albeit at less additional costs. The median incremental cost-effectiveness ratio in the OP approach group versus the control group was 5,049, implying a cost-saving per treatment responder. The OP approach was associated with a high probability that beneficial effects are obtained for fewer costs compared to the control group

197 CHAPTER 9 METHODOLOGICAL CONSIDERATIONS An important strength of this thesis was that several different research methodologies were used to study how healthcare professionals can be supported to stay healthy and well-functioning. First of all, a qualitative study gave in-depth insight into the needs of novice nurses for occupational health support early in their career. This study offered valuable and extensive information on how occupational health support for novice nurses could be improved. Secondly, the EMH approach to a mental health module for WHS was evaluated using a randomised controlled trial design. In general, this type of design is of high quality, which is important to establish evidence on the effects of occupational health interventions. 1 To increase the external validity, we aimed to design the study as real life as possible. Not individual employees but wards were randomised to one of the study groups, which is more consistent with how workers health surveillance would be performed in practice. Another important strength was the fact that we performed a cost-effectiveness analysis, since the economic evidence base for mental health promotion is scant. 2 To study a mental health module for WHS, we chose to include one large academic hospital and to invite all nurses and allied health professionals (N = 1,731) working in this hospital for participation in a randomised controlled trial. This made the evaluation a large project, with all organisational difficulties that come along with such large projects. A lot of attention was paid to informing the organisation and recruiting participants, but it still proved hard to make sure that all important stakeholders were well-informed. In addition, although the EMH approach to WHS was composed of elements that were known or could be expected to have a beneficial effect on work functioning and mental health, the low uptake of part of the approach, i.e. the self-help EMH interventions, impeded our ability to properly evaluate the effects of the EMH approach to WHS. Also, several wards were involved in other change programs at the time of our trial, and therefore participating in our trial not always suited them very well. Possibly, paying more attention to contextual factors and components of feasibility such as the acceptability and practicality of the approach would have improved it and therefore facilitated its evaluation. 3,4 In addition, this could have enabled gaining more support from management and supervisors of each ward, which is advantageous for more successful implementation of interventions. 5 In future, it is recommended to more extensively take into account the context and feasibility of a preventive occupational healthcare intervention before evaluating its (cost-) effectiveness in a randomised controlled trial. Although this procedure potentially requires more time and investments, in the long run it might lead to more useful results. 196

198 General discussion Method of screening and providing feedback In all study groups of our randomised controlled trial, we found high percentages of participants screening positive for impaired work functioning, impaired mental health, or both, indicating that the study might have attracted employees who felt that reflection on work functioning and mental health and a possible intervention would be useful or necessary to them. On the other hand, although mental health problems are known to be prevalent in healthcare professionals, one might wonder whether our screening method was too inclusive. We aimed for high sensitivity since we did not want to miss participants who might need help. The instrument which we used to measure and screen for work functioning was newly developed and further validation of the applied cut-off values is required. 6 The cut-off points that we applied for the mental health complaints were all validated. However, choosing for high sensitivity is generally associated with lower specificity, which might have led to relatively high numbers of false positives in our study. In addition, we combined several screening instruments each screening for a separate complaint or impairment, which might have added to the probability of screening positive for at least one of the complaints or impairments. Nevertheless, applying cut-off points with high sensitivity is regarded important in the light of the serious consequences that mental health problems and suboptimal work functioning might have for patient safety, quality of care and the healthcare professionals own health and safety. The feedback on personal screening results, although personalised, was automatically generated and given online immediately after filling out the screening questionnaire as well as in an . We formulated the online personalised feedback mildly, careful not to speak of diagnosis or mental health problems, to prevent incorrect interpretation. However, we received mixed reactions from some participants regarding the feedback on personal screening results. The trial also had a fairly high drop-out rate after the baseline measurement, and potential aversion in response to the personalised feedback might have played a part in this. This presumption is supported by the fact that the drop-out rate after baseline was lower in the control group (who did not receive personalised feedback) than in the two intervention groups. Reflecting on personal screening results together with a qualified professional such as an occupational physician may lead to less aversion and give the opportunity to place the results in the right perspective, helping the employee to interpret and understand the feedback as well as prevent the feedback from causing distress. 7 Therefore, it is recommended to give feedback on screening results in a personal and face-to-face consultation instead of offering automatically generated feedback. Although the process evaluation indicated that a large proportion of the participants would prefer to receive their personalised feedback immediately online or via , this group regarded the full-participating employees who probably had not been put off by the online feedback

199 CHAPTER 9 Targeting work functioning Another methodological reflection regards the innovative aspect of targeting both the health as well as the work functioning of employees. The main aim of occupational healthcare is to keep employees functioning well and as healthy as possible in their work. Therefore, information is required about the effect of an occupational health intervention not only on health but also on work functioning. When evaluating the effect of preventive occupational healthcare interventions targeting mental health on work-related outcomes, mostly sickness absence-related outcomes have been investigated. 8 However, it might be expected that a period of suboptimal work functioning precedes someone going on sick leave. To prevent serious consequences of impaired work functioning, it is important to provide support earlier. When evaluating the effect of a preventive occupational healthcare intervention, it is therefore recommended to include work functioning as an outcome. Although some studies have evaluated effects of preventive occupational healthcare interventions on work functioning, 9,10 this has mostly been evaluated using general measures of work functioning as opposed to job-specific measures. In addition, to our knowledge, job-specific screening for impairments in work functioning has not been applied before. In our trial, we used a questionnaire that was specifically developed to measure impaired work functioning of nurses and allied health professionals. 11 Although this meant that participants had to fill out a fairly long questionnaire to measure their work functioning, it also meant that the screening results gave more in-depth knowledge on how specific aspects of work functioning were affected. Furthermore, advice to improve work functioning could be tailored to the individual s specific impairments. For this reason, it is recommended to use job-specific instruments in WHS to screen for impaired work functioning. INTERPRETATION OF FINDINGS Although employers and occupational health services are required to pay attention to prevention of work-related health problems, the actual execution of preventive activities in occupational healthcare leaves much to be desired. 12 The research in this study underlines the importance of selective prevention for healthcare professionals, as we found that novice nurses already experience work-related health problems as well as impaired work functioning due to these problems early in their career. In addition, we found a high prevalence of both impaired work functioning and mental health problems in nurses and allied health professionals taking part in WHS. But how should preventive occupational healthcare be given to healthcare professionals? In the introduction of this thesis, a conceptual model was presented for the research in this thesis, focusing on finding out how healthcare professionals wish to be supported regarding their occupational health and on evaluating the use of different approaches for WHS for 198

200 General discussion healthcare professionals targeting their work functioning and mental health. Below, what is learned in this thesis is discussed. Occupational health support for healthcare professionals As shown in the model in the general introduction, the needs of novice nurses for occupational health support were the first focus of research in this thesis. The occupational health support needs that were reported by novice nurses regarded knowledge, psychosocial support and physical support. Knowledge about the negative effect that their work can have on nurses own health and vice versa and how to prevent these effects can be seen as a form of increasing personal abilities to deal with job demands and thereby preventing the effects of these job demands on novice nurses health. Psychosocial support such as a positive team climate is an example of an external resource to deal with job demands. The same applies to physical support such as appropriate ergonomic measures to prevent the development of physical health problems. The occupational health support that novice nurses called for can also help deal with existing health problems and prevent suboptimal work functioning. For example, the possibility of working less hours or performing specific tasks when dealing with health problems can help to still be able to meet job demands. One specific finding was that novice nurses need to be better introduced in how and where to seek help if they perceive problems or have difficulty to meet their job demands. It is especially worth noting that many novice nurses reported not knowing how occupational health services can help them to prevent health problems and to function optimally. The process evaluation alongside the evaluation of the mental health module for WHS also showed that occupational physicians performing preventive consultations with participants felt that the preventive consultation was useful to introduce occupational healthcare to employees and to improve the image of the occupational health services. These findings indicate the importance of better introducing employees to occupational healthcare. Accordingly, a report on the position of Dutch occupational physicians found that employees are unfamiliar with the role and tasks of occupational physicians and have limited trust in their occupational physician, partly because they think the occupational physician does not work independently from the employer. 12 In hospitals, where most of our own results derived from, employees are in relative close reach of occupational health services. Presumably, employees in other sectors are even less acquainted with occupational healthcare. Healthcare professionals starting a clinical placement or new job in a hospital are generally invited for a health check in which they are for example given the required vaccinations. This initial contact with the occupational health services could be used to better introduce the new healthcare professional to the occupational health services. For instance, an introduction consultation could be provided in which the independent role of the occupational physician can be explained and information can be 9 199

201 CHAPTER 9 given about what kind of support is available and where employees can seek help if needed. Better introducing new healthcare professionals to available resources as well as stressing the importance to seek help timely might help to indeed encourage help seeking to prevent problems in health or work. This initial contact with the occupational health services can also be used to stress the value of monitoring one s health and work functioning, encouraging employees to participate in periodically offered workers health surveillance. A study by Ruitenburg and colleagues (unpublished) shows that a considerable percentage of medical students, another group of early-career healthcare professionals, would consider taking part in WHS in the future, offering good prospects that future healthcare professionals acknowledge the need for WHS. Workers health surveillance The second focus of this thesis as presented in the conceptual model in the general introduction was on WHS for healthcare professionals. It was unknown how the mental health and work functioning of healthcare professionals could be monitored and improved best through WHS. Therefore, we evaluated two approaches. From our findings it can be concluded that an EMH approach to WHS including a tailored offer of self-help EMH interventions is insufficient to improve work functioning and mental health of healthcare professionals. An OP approach to WHS including a preventive consultation with an occupational physician improved work functioning cost-effectively. The first part of both approaches consisted of online screening on impaired work functioning and mental health, followed by personalised, but automatically generated online feedback. Part two of the EMH approach consisted of a tailored choice of self-help EMH interventions and an online educational leaflet with advice on how to improve work functioning for participants who screened positive for impaired work functioning. Part two of the OP approach formed a preventive consultation for those participants who screened positive for impaired work functioning or mental health complaints, or both. One third of invited employees participated (at baseline) in our randomised controlled trial. This participation rate is similar to that in other studies in which employees were screened on mental health complaints 10,13,14 or on general health risks. 15 In addition, it is fairly similar to the participation rate in WHS for medical specialists 16 and quite a bit higher than the participation rate in WHS for construction workers. 17 Moreover, a large percentage of healthcare professionals who participated in our complete randomised controlled trial indicated that they would appreciate to receive the opportunity to participate in WHS in future and would indeed participate. Although participation in WHS for healthcare professionals is voluntary, when implementing WHS in practice one would aim to include as many employees as possible. One possible way to achieve this is to extend WHS, adding 200

202 General discussion modules targeting the physical and general health of nurses and allied health professionals. Perhaps this would attract employees who are more interested in their physical health than their mental health. Another method which might help to increase healthcare professionals willingness to periodically participate in WHS, is to apply a shorter screening method. In the randomised controlled trial studied in this thesis, we chose to use questionnaires that are suitable for screening purposes as well as effect assessment purposes. This made filling out the screening questionnaire relatively time-consuming. For use in practice of preventive occupational healthcare for healthcare professionals, it is recommended to apply a stepwise screening method, starting with a more general and short screening. It is therefore recommended to develop a short job-specific screening questionnaire to detect early signals of impaired work functioning and mental health problems in healthcare professionals. This first screening step might be administered online, since online screening is a practical and efficient method to screen for self-reported impairments and administering self-report questionnaires online is an established method nowadays. If the short first screening phase indicates signs of impairments, the occupational physician or another healthcare provider could perform further specific screening. This way, not all employees are required to fill out a long questionnaire and for those who do need further screening, it can be explained why additional information is required. For this stepwise screening method, applying a cut-off point with high sensitivity in the first screening phase is important to make sure anyone who might need help is included in the second screening phase. The use of e-mental health in workers health surveillance As stated in the general introduction of this thesis, the use of EMH is rising and society has high expectations of it. In our research, we found that an EMH approach to WHS was not sufficiently effective in targeting impaired work functioning and mental health complaints of healthcare professionals to recommend its implementation in practice. What could be the reason for finding no effect? Two scenarios might have occurred: programme failure or theory failure, 1 meaning that either the intervention was not carried out as intended (programme failure), or the intervention was not effective (theory failure). As explained previously, the EMH approach consisted of two parts. Screening and personalised feedback regarding work functioning and mental health were received by everyone, since this was an automatic process. The onscreen educational leaflet on how to improve work functioning was also sent automatically to participants with impaired work functioning, but only one fifth of participants who received it reported to have followed the advice. In addition, participation in the offered self-help EMH interventions was low, complicating evaluation of the effect of the complete EMH approach. Thus, programme failure occurred to some extent

203 CHAPTER 9 How could the programme be executed more successfully? Self-help EMH interventions often have low compliance rates. 18,19 Possible barriers to participation in EMH interventions reported in previous literature which might have played a part in our studies are inadequate computer and Internet skills or equipment or technical problems; preference for other types of treatment; 23 and insufficient perceived need for an intervention. 21,24-26 In our pretest-posttest study we found that participants who tried an EMH intervention had worse pretest scores on work functioning and work-related mental health complaints. This indicates that participants who felt relatively worse or received online feedback reporting more impairments seemed more inclined to log onto the EMH intervention that they were offered. Possibly, most participants did not feel sufficient need for help to follow a self-help EMH intervention. Furthermore, the channelling from the personalised online feedback towards the EMH interventions might not have been attractive enough to encourage participants to follow an EMH intervention. 22 Also, we offered several fitting EMH interventions to leave room for personal preferences. Most participants had to decide whether they wanted to follow an EMH intervention, but also which one. This might have made the option to not participate more attractive. Lastly, evidence indicates that support increases (prolonged) participation in EMH interventions. 27,28 These reflections offer important points of action to improve participation in the EMH interventions. Most of these problems could be addressed through application of a blended care method in which face-to-face and online care are combined. When discussing personal screening results with the employee, as recommended previously, the occupational physician or other healthcare provider could additionally assess and discuss the applicability of following a self-help EMH intervention for this specific employee. Subsequently, the healthcare provider could fulfill a monitoring role, periodically discussing the progress with the employee. This form of support alongside an EMH intervention could also be beneficial for its effect This form of offering WHS would partly diminish some of the advantages of self-help, such as being able to receive help without having to admit to someone that you experience health problems. Nevertheless, in the light of the findings presented in this thesis, only offering self-help EMH interventions is insufficient to improve work functioning and mental health of healthcare professionals. Yet theory failure may also have posed a problem. The educational leaflet on how to improve work functioning was based on the Dutch evidence-based guideline for occupational physicians on treating employees with mental health problems. 32 It also more or less followed the structure of the protocol that was developed for the occupational physicians who provided the preventive consultations within the OP approach for WHS in our study. 6 Nevertheless, receiving advice through a leaflet or in a consultation with an OP are two different strategies, and it is conceivable that they might not have the same effect on work functioning. Several of the self-help EMH interventions that were offered have had positive effects regarding reduction of symptoms of impaired mental health in 202

204 General discussion previous research However, most of the participants in these studies had actively sought help and improvement through EMH interventions, which might have meant that EMH interventions were suitable for them, while in our study this cannot automatically be assumed. In addition, the effects of the self-help EMH interventions on work functioning have not been researched. The cost-effectiveness analysis revealed that the EMH approach to WHS was associated with a smaller likelihood of beneficial effects regarding work functioning than a control group. However, the EMH approach was also associated with less costs than the control group. Although obviously lower costs form an attractive outcome, from an occupational healthcare perspective it is more important to improve healthcare professionals work functioning. Therefore, implementation of the EMH approach in the current form is not recommended. So, is e-health useful for prevention in occupational healthcare? Since the EMH approach to WHS was not carried out as intended, we cannot conclude that the complete EMH approach to WHS targeting work functioning and mental health of healthcare employees is ineffective. Nevertheless, taking into account that in a preventive setting, healthcare professionals may not be sufficiently aware of health problems or impaired work functioning, e-health does not seem sufficient to tackle these problems. Although certainly some elements of occupational health support or WHS may be delivered via online methods, prevention in occupational healthcare should start with an adequate introduction of healthcare professionals to available occupational health services. Targeting the work environment The importance of maintaining or increasing personal abilities to deal with job demands was underlined by the reported occupational health support needs of healthcare professionals. However, improving the organisation and the available resources to decrease the negative effect of work on employees health is just as important 38 and may lead to positive individual as well as organisational outcomes despite many of the health risks being part of the job. Employers find it difficult to tackle psychosocial risk factors in the workplace. They are considered a sensitive topic, there is a lack of awareness of psychosocial risk factors, and the organisational culture makes it difficult to tackle these risk factors. 42 However, reducing psychosocial risks factors on an organisational level, such as through improving communication, has shown to indeed reduce these risk factors and to improve healthcare professionals mental health. 41 A study by Sun and colleagues investigated a workplace mental health promotion programme, including both organisational policies (e.g. on anti-bullying) but also more individual components such as skills training in stress management. They found positive effects on stress, the ability to meet mental work demands, and work ability. 43 Therefore, it seems worthwhile for organisations to 9 203

205 CHAPTER 9 overcome their reluctance and pay attention to organisational interventions as well to improve the workplace in which employees do their jobs. WHS could help detect problems or points for improvement in the organisation or a specific team. If a large proportion of a team experiences health problems or impaired work functioning, it could be further explored what the reasons are and whether sufficient help is in place. When implementing WHS in practice, it is recommended for occupational health services and employers to keep this additional goal in mind. RECOMMENDATIONS FOR PRACTICE AND RESEARCH Recommendations for practice Occupational health services for healthcare professionals are recommended to better acquaint employees with occupational healthcare, especially at the start of their career. One method might be to provide an introduction consultation in which information can be given about what kind of support is available and where employees can seek help if needed. Nurse educators are recommended to include a component in the curriculum offered to nursing students, regarding health risks due to working in nursing, consequences of these health risks and measures to prevent these consequences. Workers health surveillance for healthcare professionals should be implemented using the approach with a preventive consultation with an occupational physician. Self-help e-mental health interventions can be embedded in the intervention protocol. In addition, the workers health surveillance should be extended to also include modules targeting physical and general health. Managers of healthcare professionals should be aware of the effect that working in healthcare can have on work functioning, and of the potential financial benefits of monitoring and improving healthcare professionals health and work functioning. Recommendations for research It is recommended to monitor the health and work functioning of nurses during their career, beginning at the start of their career and using a cohort research design. This way, insight can be gained into predictors of work-related health problems and impaired work functioning. This could help improve occupational health support for (novice) nurses. For the evaluation of preventive interventions in occupational healthcare, it is recommended to pay much attention to contextual and feasibility factors of the intervention, before evaluating its (cost-)effectiveness in a randomised controlled trial. When evaluating the effect of a preventive intervention in an occupational context, it is recommended to include work functioning as an outcome. 204

206 General discussion REFERENCES 1 Kristensen TS. Intervention studies in occupational epidemiology. Occup Environ Med 2005; 62: Zechmeister I, Kilian R, McDaid D. Is it worth investing in mental health promotion and prevention of mental illness? A systematic review of the evidence from economic evaluations. BMC Public Health 2008; 8:20. 3 Campbell NC, Murray E, Darbyshire J et al. Designing and evaluating complex interventions to improve health care. BMJ 2007; 334: Bowen DJ, Kreuter M, Spring B et al. How we design feasibility studies. AM J Prev Med 2009; 36: Murta SG, Sanderson K, Oldenburg B. Process evaluation in occupational stress management programs: a systematic review. Am J Health Promot 2007; 21: Gärtner FR. Work functioning impairments due to common mental disorders. Measurement and prevention in nurses and allied health professionals (Doctoral Dissertation). Amsterdam, the Netherlands: University of Amsterdam, Buchanan T. Online Assessment: Desirable or Dangerous? Professional Psychology: Research and Practice 2002; 33: Pomaki G, Franche RL, Murray E et al. Workplace-based work disability prevention interventions for workers with common mental health conditions: a review of the literature. J Occup Rehabil 2012; 22: Lerner D, Adler D, Hermann RC et al. Impact of a Work-Focused Intervention on the Productivity and Symptoms of Employees With Depression. J Occup Environ Med 2012; 54: Wang PS, Simon GE, Avorn J et al. Telephone screening, outreach, and care management for depressed workers and impact on clinical and work productivity outcomes. JAMA 2007; 298: Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health 2012; 85: de Zwart BCH, Prins R, van der Gulden JWJ. Investigation of the position of the occupational physician [in Dutch: Onderzoek naar de positie van de bedrijfsarts]. Leiden, the Netherlands: AStri Beleidsonderzoek- en advies, Harvey SB, Glozier N, Henderson M et al. Depression and work performance: an ecological study using Web-based screening. Occup Med (Lond) 2011; 61: Lexis MA, Jansen NW, Huibers MJ et al. Prevention of long-term sickness absence and major depression in high-risk employees: a randomised controlled trial. Occup Environ Med 2011; 68: Colkesen EB, Kraaijenhagen RA, Frings-Dresen MHW et al. Participation in a workplace Web-based health risk assessment program. Occup Med (Lond) 2011; 61: Ruitenburg M, Plat MCJ, Frings-Dresen MHW, Sluiter JK. (Staying) healthy at work for medical specialists (in training): development and pilot implementation of workers health surveillance [in Dutch: Gezond (blijven) werken voor medisch specialisten (i.o.): ontwikkeling en pilot-implementatie van een preventief medisch onderzoek]. Amsterdam, the Netherlands: Coronel Institute of Occupational Health, AMC/UvA, Report no.: Boschman JS, van der Molen HF, Sluiter JK, Frings-Dresen MH. Improving occupational health care for construction workers: a process evaluation. BMC Public Health 2013; 13: Eysenbach G. The law of attrition. J Med Internet Res 2005; 7:e Melville KM, Casey LM, Kavanagh DJ. Dropout from Internet-based treatment for psychological disorders. Br J Clin Psychol 2010; 49: Gerhards SA, Abma TA, Arntz A et al. Improving adherence and effectiveness of computerised cognitive behavioural therapy without support for depression: a qualitative study on patient experiences. J Affect Disord 2011; 129: Brouwer W, Oenema A, Crutzen R et al. What makes people decide to visit and use an internet-delivered behavior-change intervention? A qualitative study among adults. Health Education 2009; 109: Schneider F, van Osch L, de Vries H. Identifying factors for optimal development of health-related websites: a delphi study among experts and potential future users. J Med Internet Res 2012; 14:e Grime PR. Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism. Occup Med (Lond) 2004; 54:

207 CHAPTER 9 24 Lexis MA, Jansen NW, Stevens FC et al. Experience of health complaints and help seeking behavior in employees screened for depressive complaints and risk of future sickness absence. J Occup Rehabil 2010; 20: Codony M, Alonso J, Almansa J et al. Perceived need for mental health care and service use among adults in Western Europe: results of the ESEMeD project. Psychiatr Serv 2009; 60: Cuijpers P, Donker T, van Straten A et al. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med 2010; 40: Ritterband LM, Thorndike FP, Cox DJ et al. A behavior change model for internet interventions. Ann Behav Med 2009; 38: de Graaf LE, Huibers MJ, Riper H et al. Use and acceptability of unsupported online computerized cognitive behavioral therapy for depression and associations with clinical outcome. J Affect Disord 2009; 116: Andersson G, Carlbring P, Berger T et al. What makes Internet therapy work? Cogn Behav Ther 2009; 38 Suppl 1: Spek V, Cuijpers P, Nyklicek I et al. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med 2007; 37: Palmqvist B, Carlbring P, Andersson G. Internet-delivered treatments with or without therapist input: does the therapist factor have implications for efficacy and cost? Expert Rev Pharmacoecon Outcomes Res 2007; 7: van der Klink JJ & van Dijk FJ. Dutch practice guidelines for managing adjustment disorders in occupational and primary health care. Scand J Work Environ Health 2003; 29: Bolier L, Haverman M, Kramer J et al. An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial. J Med Internet Res 2013; 15:e Warmerdam L, van Straten A, Twisk J et al. Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res 2008; 10:e Riper H, Kramer J, Smit F et al. Web-based self-help for problem drinkers: a pragmatic randomized trial. Addiction 2008; 103: Spek V, Nyklicek I, Smits N et al. Internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years old: a randomized controlled clinical trial. Psychol Med 2007; 37: Spek V, Cuijpers P, Nyklicek I et al. One-year follow-up results of a randomized controlled clinical trial on internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years. Psychol Med 2008; 38: Gunusen NP & Ustun B. Turkish nurses perspectives on a programme to reduce burnout. Int Nurs Rev 2009; 56: Bourbonnais R, Brisson C, Vinet A et al. Effectiveness of a participative intervention on psychosocial work factors to prevent mental health problems in a hospital setting. Occup Environ Med 2006; 63: Lamontagne AD, Keegel T, Louie AM et al. A systematic review of the job-stress intervention evaluation literature, Int J Occup Environ Health 2007; 13: Bourbonnais R, Brisson C, Vezina M. Long-term effects of an intervention on psychosocial work factors among healthcare professionals in a hospital setting. Occup Environ Med 2011; 68: Hooftman W, van der Klauw M, Klein Hesselink J et al. Arbobalans Kwaliteit van de arbeid, effecten en maatregelen in Nederland. Hoofddorp, the Netherlands: TNO, Sun J, Buys N, Wang X. Effectiveness of a workplace-based intervention program to promote mental health among employees in privately owned enterprises in China. Popul Health Manag 2013; 16:

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210 SUMMARY SAMENVATTING

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212 Summary SUMMARY Working in healthcare involves meeting high job demands, which can have serious consequences for healthcare professionals health and work functioning and their patients safety. Therefore, attention should be paid to the prevention of work-related health problems and impaired work functioning of healthcare professionals. With appropriate help or interventions, healthcare professionals can be supported to stay healthy and to remain well-functioning in their profession until retirement age. The main objectives of this thesis are to assess novice nurses needs for occupational health support and to evaluate two approaches to a mental health module for job-specific workers health surveillance (WHS) for nurses and allied health professionals. The following research questions are addressed: 1. What are the occupational health support needs of novice nurses to keep them healthy and well-functioning in their (future) work? 2. How do nurses, allied health professionals and occupational physicians evaluate a mental health module for WHS? 3. What is the effect of an e-mental health (EMH) approach to WHS on the work functioning and mental health of nurses and allied health professionals? 4. What is the cost-effectiveness regarding work functioning of two different approaches to a mental health module for WHS? Objective 1: Assessment of needs of novice nurses regarding occupational health support What are the occupational health support needs of novice nurses to keep them healthy and well-functioning in their (future) work? Chapter 2 shows that novice nurses report a need for occupational health support during education in the form of knowledge, for instance through paying attention in class to dealing with shift work; and in the form of psychosocial support, such as career counselling. Furthermore, they report a need for occupational health support at the start of their clinical placement or new job, also in the form of knowledge, such as information from occupational health services; and psychosocial support, for instance by being paired to a mentor. In addition, they report a need for occupational health support which is embedded in the workplace in general and is not only given at the start of working in nursing. This form of occupational health support again encompasses knowledge such as tailored advice on proper lifting position; psychosocial support such as fostering a positive team atmosphere; but also physical support such as suitable preventive measures. These findings result from a qualitative interview study which was conducted with 14 nursing students and newly qualified nurses, together defined as novice nurses. This study aimed to investigate novice nurses occupational health support needs to prevent 211

213 Summary work-related health problems and to help them function optimally in their work in spite of health problems. Findings also indicate that novice nurses already experience work-related health problems early in their career, such as musculoskeletal problems, stress and worrying, anxiety, fatigue, sleeping problems, and infectious diseases. Reported causes are physical work demands, disagreeable contact with others, workload, accidents with biological material and otherwise being exposed to infectious diseases, working shifts, and making mistakes. Participants also describe experiences with how health problems have led to suboptimal work functioning. Objective 2: Evaluation of two approaches to a mental health module for job-specific workers health surveillance for nurses and allied health professionals One form of occupational health support is conducting WHS, which is a method to periodically monitor employees health and work functioning. It is targeted towards early detection of impairments and offering timely interventions to improve health and work functioning. For this thesis, it was decided to target mental health specifically, since mental health problems form a significant but also an often invisible problem for healthcare professionals. Furthermore, healthcare professionals have difficulty asking for timely help when experiencing mental health problems. However, in light of the possible consequences of mental health problems for quality of care and patient safety and healthcare professionals own health and safety, it is important to receive help timely. Two different approaches to a mental health module for WHS for nurses and allied health professionals were evaluated in a large randomised controlled trial. The design for this trial is described in Chapter 3. All nurses and allied health professionals (N = 1,731) working in one academic hospital were invited to participate in the trial and randomised to one of the approaches or a control group. Both approaches consisted of screening on impaired work functioning, distress, work-related fatigue, depressive symptoms, anxiety symptoms, panic disorder, posttraumatic stress and risky drinking behaviour. Subsequently, participants in both approaches received automatically generated personalised feedback on their screening results, onscreen and in an . In the first, more innovative, EMH approach this was followed by tailored access to self-help EMH interventions, i.e. an intervention to improve mental fitness for participants screening negative for mental health complaints or a choice of fitting e-mental health interventions for those screening positive for mental health complaints. Participants screening positive for impaired work functioning also received an onscreen educational leaflet with advice on how to improve work functioning. In the conventional occupational physician (OP) approach, for participants screening positive for impairments in either work functioning or mental health or both, screening and personalised feedback on screening results were followed by an invitation for a preventive consultation with their own occupational physician. 212

214 Summary The EMH approach was compared to the OP approach and to the control group, in which participants received no personalised feedback or further interventions. Study outcomes were impaired work functioning, distress, work-related fatigue, posttraumatic stress and work ability, assessed at baseline and three and six months after baseline. It was hypothesised that regarding these outcomes, the EMH approach is not inferior to the OP approach and is superior to the control group. How do nurses, allied health professionals and occupational physicians evaluate a mental health module for workers health surveillance? The mental health module for WHS was well received by participating nurses and allied health professionals. It also fits in the activities of the occupational health service and was perceived as meaningful by the participating occupational physicians. However, compliance to the complete EMH approach including the self-help EMH interventions was low, while compliance to the complete OP approach including the preventive consultation with an occupational physician was much higher. These conclusions are based on the findings in Chapter 4, in which the process evaluation that is performed alongside the randomised controlled trial is described. This process evaluation describes participants response and compliance to the intervention in both approaches and their perspectives on the mental health module for WHS. In addition, it describes the occupational physicians adherence to the consultation protocol and their perspectives on the OP approach to WHS. The process evaluation shows that 32% of the 1,731 invited nurses and allied health professionals participated in the trial. All participants in both approaches received the first part of the intervention, consisting of screening and personalised feedback. In the EMH approach, 16% of participants logged onto an EMH intervention and 5% started it to at least some extent. The advice on improving work functioning, given in an onscreen educational leaflet, was followed by 23% of the participants who report to have received it. Of the invited participants in the OP approach group, 41% went to the preventive consultation and 80% followed the OP s advice if this was given to them. In both groups, most participants would (maybe) appreciate to be offered WHS in the future (74-79%) and would (maybe) participate in a future mental health module for WHS aimed at mental health and work functioning (82-84%). The adherence of OPs to the consultation protocol was high, as in most cases all steps were followed. The OPs were satisfied with the consultation protocol and training and felt that the preventive consultations were meaningful. They also considered it to be meaningful to implement a WHS mental health module in the future. 213

215 Summary What is the effect of an e-mental health approach to workers health surveillance on the work functioning and mental health of nurses and allied health professionals? It can be concluded that the EMH approach to a mental health module for WHS does not lead to a statistically significant larger effect on work functioning, distress, work-related fatigue, posttraumatic stress and work ability compared to a control group. However, the EMH approach also does not lead to a statistically significant larger or smaller effect on these outcomes than the OP approach. Over time, the EMH approach shows a statistically significant effect on work functioning and work-related fatigue and a relevant but small effect on distress. These conclusions are derived from Chapters 5-7. In Chapter 5, the evaluation of the EMH approach to a mental health module for WHS compared to the OP approach is described. Almost 80% of participating nurses and allied health professionals screened positive for impaired work functioning, mental health problems, or both. Both the EMH approach group and the OP approach group improved over time regarding impaired work functioning (non-significant interaction effect between groups). In addition, a considerable percentage of participants in both groups improved relevantly regarding work functioning: regarding participants who screened positive for impairments, 30% in the EMH approach group and 46% in the OP approach group showed relevantly improved work functioning after three months, while 36% and 41%, respectively, showed relevantly improved work functioning after six months (both non-significant between-group differences). Differences between the two approaches do not exceed the pre-defined criterion of >10 points on work functioning, indicating non-inferiority of the EMH approach compared to the OP approach. However, the OP approach group trended towards better performance on work functioning. Regarding distress, work-related fatigue and posttraumatic stress, both groups also improved over time, and both groups remained relatively stable regarding work ability. No statistically significant differences in effect between the two approaches were found. The evaluation of the EMH approach to a mental health module for WHS compared to the control group is described in Chapter 6. More than 80% of participants screened positive for impaired work functioning, mental health problems, or both. Both the EMH approach group and the control group improved over time on work functioning, distress, work-related fatigue, and posttraumatic stress, and remained relatively stable regarding work ability. In the subgroup that screened positive for impairments, no statistically significant differences were found between the groups. However, when including all participants in the analyses and not only those who screened positive on impairments at baseline, the work functioning of the EMH approach group showed a significantly different pattern compared to the control group (p = 0.04), as the EMH approach group further 214

216 Summary improved between three and six months after baseline while the control group did not. After three months, in both groups a relevant improvement of work functioning was found for 30% of participants who screened positive for impairments. After six months, a relevant improvement of work functioning was found for 36% of participants in the EMH approach group and 28% in the control group, but the difference between the groups was non-significant. The randomised controlled trial suffered high drop-out rates and low compliance rates to the self-help EMH interventions that were offered. The control group was designed as a waiting-list group and received the EMH approach to WHS after their participation in the randomised controlled trial. Their follow-up questionnaire after six months doubled as a screening instrument to offer them personalised feedback on screening results and tailored access to self-help EMH interventions and the onscreen educational leaflet for improving work functioning, if applicable. Participants in this original control group were also asked if they were willing to fill out an additional questionnaire, to measure the effects of the EMH approach after three months. The pre-intervention and post-intervention data after three months of the original EMH approach group and the original control group were combined and the effects over time on impaired work functioning, distress and work-related fatigue were studied. The results of this study are presented in Chapter 7. For 128 nurses and allied health professionals, a score on both time points was available. In this group, significant improvements over time were found on work functioning (p = 0.01) and work-related fatigue (p < 0.01) but not on distress. Work functioning improved relevantly in 30% of participants. Twenty-six participants logged onto a self-help EMH intervention. In this subgroup, a small meaningful effect on stress was found (Cohen s d = 0.23). Regarding all three outcomes, the subgroup of participants who logged on at least once to an EMH intervention scored worse than the total group, both at pretest and at posttest, but also showed a larger improvement over time. What is the cost-effectiveness regarding work functioning of two different approaches to a mental health module for workers health surveillance? It can be concluded that the EMH approach to a mental health module for WHS is not cost-effective regarding work functioning, when compared to the control group. The costs per additional relevantly improved participant were higher in the EMH approach than in the control group. The OP approach, however, leads to a saving in costs per relevantly improved participant when compared to the control group. Therefore, the OP approach is cost-effective regarding work functioning. The findings leading to this conclusion are described in Chapter 8, in which the cost-effectiveness of the EMH approach and the OP approach to a mental health module for WHS is presented. In this study, we define treatment responders as participating nurses 215

217 Summary and allied health professionals who have relevantly improved work functioning after six months compared to their baseline score. The cost-effectiveness analysis was conducted from a societal perspective, irrespective of who bears the costs or receives the benefits. To assess resource use and costs, intervention costs, direct medical costs, and direct and indirect non-medical costs were taken into account. The incremental cost-effectiveness ratio was calculated, which can be interpreted as the net costs or savings per additional treatment responder. The proportion of treatment responders was 16% in the EMH approach group, 24% in the OP approach group and 20% in the control group. The average per-responder costs were 1,375 in the EMH approach group, 1,266 in the OP approach group, and 1,752 in the control group. The EMH approach was associated with a high probability of fewer benefits regarding work functioning as compared to the control group, albeit at less additional costs (median incremental cost-effectiveness ratio = 4,054 per treatment responder). The OP approach was associated with a greater likelihood that beneficial effects are obtained for fewer costs compared to the control group (median incremental cost-effectiveness ratio = 5,049 per treatment responder). In conclusion, the research presented in this thesis underlines the importance of occupational health support for healthcare professionals, to prevent work-related health problems and help them function optimally in their work. Novice nurses have a need for knowledge, psychosocial support and physical support to remain healthy and wellfunctioning in their (future) work. Nurse educators are recommended to include a component in the curriculum offered to nursing students, regarding health risks due to working in nursing, consequences of these health risks and measures to prevent these consequences. In addition, occupational health services for healthcare professionals are recommended to better acquaint employees with occupational healthcare, especially at the start of their career, so that employees know where to seek help when needed. For further research, it is proposed to monitor the health and work functioning of nurses during their career, beginning at the start of their career and using a cohort research design. This way, insight can be gained into predictors of work-related health problems and impaired work functioning. This could help improve occupational health support for (novice) nurses. It can also be concluded that implementation of the EMH approach to a mental health module for WHS in its current form cannot be recommended. However, it can be recommended to implement the OP approach to a mental health module for WHS, since this approach improves work functioning cost-effectively. Therefore, it is recommended to implement WHS in which a preventive consultation with an occupational physician is included. Self-help e-mental health interventions can be embedded in the intervention protocol. In addition, the workers health surveillance should be extended to also include modules targeting physical and general health. Furthermore, managers of healthcare 216

218 Summary professionals should be aware of the effect that working in healthcare can have on work functioning, and of the potential financial benefits of monitoring and improving healthcare professionals health and work functioning. Regarding future research of preventive interventions in occupational healthcare, it is recommended to pay attention to contextual and feasibility factors of the intervention before evaluating its (cost-)effectiveness in a randomised controlled trial. A last recommendation is to include work functioning as an outcome when evaluating the effect of a preventive intervention in an occupational context. 217

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220 Samenvatting SAMENVATTING Aanleiding In dit proefschrift is onderzocht hoe de preventie van werk-gerelateerde gezondheidsproblemen en daaraan gerelateerd verminderd werk-functioneren voor werknemers in gezondheidszorg verbeterd kan worden. Werknemers in de zorg hebben namelijk te maken met verschillende fysieke en psychosociale taakeisen die een risico vormen voor hun eigen gezondheid. Voorbeelden van taakeisen voor verpleegkundigen en paramedici zijn het veelvuldig tillen, draaien en vervoeren van patiënten en het bieden van emotionele ondersteuning aan patiënten en hun familieleden. Fysieke en psychische gezondheidsproblemen komen dan ook vaak voor bij deze beroepsgroep. Op zichzelf is dit al een belangrijke reden om aandacht te besteden aan het voorkómen van werk-gerelateerde gezondheidsproblemen bij verpleegkundigen en paramedici. Gezondheidsproblemen bij deze werknemers leiden echter mogelijk ook tot verminderd functioneren in het werk, wat een gevaar kan vormen voor de kwaliteit van zorg, de patiëntveiligheid, maar ook de eigen veiligheid. Dit proefschrift heeft twee hoofddoelen. Uit eerder onderzoek blijkt dat verpleegkundigen al tijdens hun studie te maken hebben met werk-gerelateerde gezondheidsproblemen. Hierdoor lijkt het van belang om al vroeg in hun carrière ondersteuning aan te bieden om gezond te blijven en zo goed mogelijk te (blijven) functioneren in hun werk. Omdat onbekend is hoe beginnende verpleegkundigen ondersteund willen worden op dit vlak, is het eerste doel van dit proefschrift om wensen en behoeften ten aanzien van deze ondersteuning te onderzoeken. Het tweede doel van dit proefschrift is de evaluatie van twee verschillende strategieën voor het uitvoeren van een Preventief Medisch Onderzoek (PMO) gericht op de psychische gezondheid van verpleegkundigen en paramedici. PMO is een sociaal-medisch onderzoek waarmee periodiek naar de gezondheid gerelateerd aan het werk, maar ook naar het werk-functioneren wordt gekeken. Op die manier kunnen werk-gerelateerde gezondheidsproblemen en verminderd werk-functioneren tijdig worden gesignaleerd en kan begeleiding tijdig worden aangeboden. De focus van het PMO dat wordt geëvalueerd in dit proefschrift ligt op de psychische gezondheid, omdat psychische problemen een groot maar vaak ook relatief onzichtbaar probleem vormen voor werknemers in de gezondheidszorg. Daarnaast hebben werknemers in de gezondheidszorg die kampen met psychische problemen moeite om hier hulp voor te vragen. Echter, gezien de gevaren van psychische problemen voor de kwaliteit van zorg en de patiëntveiligheid maar ook de eigen gezondheid, is het juist van belang om vroegtijdig hulp te ontvangen. 219

221 Samenvatting In dit proefschrift wordt een innovatieve e-mental health (EMH) strategie voor PMO vergeleken met een conventionele strategie die wordt uitgevoerd door een bedrijfsarts. Daarnaast wordt de EMH strategie vergeleken met een controlegroep waarin geen PMO wordt aangeboden. In het EMH-PMO wordt gebruik gemaakt van zelfhulp internetcursussen om de psychische gezondheid te verbeteren. Deze zelfhulp internetcursussen bieden werknemers veel vrijheid, bijvoorbeeld doordat ze in eigen tempo maar ook op een zelfgekozen moment gevolgd kunnen worden. Daarnaast kunnen zelfhulp internetcursussen mogelijk het zoeken van hulp vergemakkelijken, omdat men door de anonimiteit van een internetcursus niet geconfronteerd wordt met het stigma rondom psychische problemen. Doel 1: Onderzoeken hoe beginnende verpleegkundigen ondersteund willen worden om gezond te blijven en optimaal te blijven functioneren in hun werk Om gezond te blijven in hun werk en zo goed mogelijk te blijven functioneren hebben beginnende verpleegkundigen behoefte aan ondersteuning tijdens de opleiding, ondersteuning aan het begin van een stage of een nieuwe baan en ondersteuning met een meer structurele plaats in het werk, dat wil zeggen niet alleen gericht op beginnende maar op alle verpleegkundigen. Beginnende verpleegkundigen rapporteren ten eerste een behoefte aan kennis op het gebied van werk en gezondheid. Tijdens de opleiding kan er bijvoorbeeld aandacht besteed worden aan het omgaan met wisselende diensten. Aan het begin van een stage of een nieuwe baan kan informatie gegeven worden over de bedrijfsgezondheidsdienst en over mogelijkheden voor het krijgen van hulp als men gezondheidsproblemen heeft. Daarnaast is er behoefte aan bijvoorbeeld terugkerende aandacht voor een goede werkhouding, in de vorm van advies-op-maat bij het tillen van patiënten. Ook hebben beginnende verpleegkundigen behoefte aan psychosociale ondersteuning, bijvoorbeeld loopbaanadvies tijdens de opleiding, het hebben van een mentor aan het begin van een nieuwe baan en het bevorderen van een goede teamsfeer als een vorm van meer structurele ondersteuning. Ten slotte is er behoefte aan fysieke ondersteuning, bijvoorbeeld in de vorm van passende maatregelen en hulpmiddelen om werk-gerelateerde gezondheidsproblemen te voorkomen. Deze bevindingen komen voort uit een kwalitatieve interviewstudie (Hoofdstuk 2) die is uitgevoerd met 14 beginnende verpleegkundigen, dat wil zeggen verpleegkundestudenten met enige stage-ervaring en pas afgestudeerde verpleegkundigen. Uit deze studie blijkt verder dat beginnende verpleegkundigen al vroeg in hun carrière als verpleegkundige te maken krijgen met werk-gerelateerde gezondheidsproblemen, zoals klachten aan het houding- en bewegingsapparaat; stress en piekeren; angstklachten; vermoeidheidsklachten; slaapproblemen; en infectieziekten. Oorzaken van deze werk-gerelateerde gezondheidsproblemen zijn de fysieke belasting; blootstelling aan lichaamsmateriaal van patiënten, 220

222 Samenvatting antibiotica en patiënten met infectieziektes; het werken van wisselende diensten; de hoge werkdruk; het maken van fouten; en vervelend contact met bijvoorbeeld patiënten of familieleden van patiënten maar ook collega s. Ook rapporteren de deelnemende verpleegkundigen verschillende ervaringen met hoe gezondheidsproblemen hebben geleid tot verminderd functioneren. Doel 2: De evaluatie van twee verschillende strategieën voor het uitvoeren van een Preventief Medisch Onderzoek gericht op de psychische gezondheid van verpleegkundigen en paramedici Twee verschillende strategieën zijn ontwikkeld voor een PMO gericht op de psychische gezondheid. In beide strategieën is aan deelnemende verpleegkundigen en paramedici gevraagd een online zelfrapportage vragenlijst in te vullen om te onderzoeken of er bij hen sprake is van signalen van psychische gezondheidsproblemen (stress, werk-gerelateerde vermoeidheid, depressie, angst, posttraumatische stress of riskant alcoholgebruik) en/of signalen van verminderd werk-functioneren. Na het invullen van de vragenlijst hebben deelnemers via een automatisch systeem een terugkoppeling ontvangen van hun persoonlijke scores op de verschillende onderdelen van psychische gezondheid en werkfunctioneren. Daarop aansluitend hebben deelnemers van het EMH-PMO het aanbod ontvangen om een zelfhulp internetcursus te volgen. Het aanbod voor een zelfhulp internetcursus is aangepast op de individuele resultaten met betrekking tot psychische gezondheid en werk-functioneren. Deelnemers met verminderd werk-functioneren hebben tevens een digitale folder ontvangen met tips en adviezen om het werk-functioneren te verbeteren. In de conventionele strategie, het bedrijfsarts-pmo, zijn deelnemers waarbij signalen zijn gevonden voor psychische gezondheidsproblemen en/of verminderd werkfunctioneren uitgenodigd voor een preventief consult met hun eigen bedrijfsarts. In dit consult is gebruik gemaakt van een 7-stappen protocol. Alle verpleegkundigen en paramedici werkzaam in één universitair medisch centrum zijn uitgenodigd om mee te doen aan een onderzoek om deze strategieën voor PMO te evalueren. De opzet van dit cluster-gerandomiseerde onderzoek wordt beschreven in Hoofdstuk 3. De afdelingen waar verpleegkundigen en paramedici werken zijn op basis van toeval verdeeld over drie groepen: één groep is uitgenodigd om deel te nemen aan het EMH-PMO, één groep is uitgenodigd om deel te nemen aan het bedrijfsarts-pmo en één controlegroep heeft tijdens deze studie alleen de onderzoeksvragenlijsten ingevuld. Metingen zijn verricht bij de start van het onderzoek, na drie maanden en na zes maanden. De controlegroep vormde een wachtlijstgroep voor het EMH-PMO. Dit betekent dat zij de mogelijkheid hebben ontvangen om deel te nemen aan het EMH-PMO na afloop van hun deelname aan het cluster-gerandomiseerde onderzoek. 221

223 Samenvatting Hoe wordt een module voor Preventief Medisch Onderzoek gericht op psychische gezondheid door de gebruikers geëvalueerd? Het PMO gericht op de psychische gezondheid is door deelnemende verpleegkundigen en paramedici goed gewaardeerd. Daarnaast blijkt het mogelijk om het PMO te integreren in de activiteiten van de bedrijfsgezondheidszorgdienst en is het PMO ook door de deelnemende bedrijfsartsen als zinvol ervaren. Deelname aan het gehele EMH-PMO inclusief de aangeboden zelfhulp internetcursussen was laag, terwijl deelname aan het gehele bedrijfsarts-pmo inclusief een preventief consult met de bedrijfsarts redelijk hoog was. Deze bevindingen komen voort uit de procesevaluatie van het cluster-gerandomiseerde onderzoek, beschreven in Hoofdstuk 4. Uit deze evaluatie blijkt dat één derde van de uitgenodigde verpleegkundigen en paramedici hebben meegedaan aan de basismeting bij de start van de studie. Alle deelnemers in het EMH-PMO en het bedrijfsarts-pmo hebben het eerste deel van het PMO gericht op psychische gezondheid ontvangen, bestaande uit screening en een gepersonaliseerde terugkoppeling. Zestien procent van de deelnemers in het EMH-PMO heeft vervolgens ingelogd bij een van de zelfhulp internetcursussen. Vijf procent van hen heeft ook een deel van een internetcursus gevolgd. Een kwart van de deelnemers met verminderd werk-functioneren, die de digitale folder hebben ontvangen met tips en adviezen om het werk-functioneren te verbeteren, geeft aan dat zij deze tips en adviezen hebben opgevolgd. In het bedrijfsarts-pmo is 41% van de deelnemers ingegaan op de uitnodiging voor een preventief consult met de bedrijfsarts. Tachtig procent van de mensen die in het preventief consult advies hebben ontvangen, geeft aan deze adviezen te hebben opgevolgd. Driekwart van de deelnemers van het EMH-PMO en het bedrijfsarts-pmo geven aan het (misschien) te waarderen om in de toekomst een PMO aangeboden te krijgen. Ruim vier op de vijf deelnemers geeft aan (misschien) deel te nemen aan een toekomstig PMO gericht op de psychische gezondheid en het werk-functioneren. De deelnemende bedrijfsartsen zijn tevreden met het protocol voor het preventieve consult en de training in het gebruik ervan. Zij hebben in bijna alle consulten alle stappen van het protocol gevolgd. De bedrijfsartsen geven aan de preventieve consulten zinvol te vinden en zijn van mening dat het zinvol is om in de toekomst een PMO gericht op de psychische gezondheid en het werk-functioneren te implementeren. Verbetert een module voor Preventief Medisch Onderzoek gericht op psychische gezondheid, waarbij gebruik gemaakt wordt van e-mental health, het werkfunctioneren en de psychische gezondheid van verpleegkundigen en paramedici? Uit dit proefschrift blijkt dat een EMH-PMO gericht op de psychische gezondheid van verpleegkundigen en paramedici geen groter effect heeft op werk-functioneren, stress, werk-gerelateerde vermoeidheid, posttraumatische stress en werkvermogen dan een controlegroep. Het EMH-PMO doet het echter statistisch gezien ook niet beter of slechter 222

224 Samenvatting dan een bedrijfsarts-pmo wat betreft effecten op deze uitkomstmaten. Over de tijd heeft het EMH-PMO een statistisch significant effect op werk-functioneren en werk-gerelateerde vermoeidheid en een relevant maar klein effect op stress. Deze conclusies komen voort uit de bevindingen in Hoofdstukken 5 t/m 7. Bij ongeveer 80% van alle deelnemende verpleegkundigen en paramedici zijn signalen gevonden van psychische gezondheidsproblemen en/of verminderd werk-functioneren. In Hoofdstuk 5 wordt het effect van het EMH-PMO vergeleken met het effect van het bedrijfsarts-pmo. In beide groepen is een verbetering waargenomen van werk-functioneren. Er is geen significant verschil tussen de groepen. Daarnaast is er gekeken van hoeveel deelnemers met een verminderde psychische gezondheid en/of verminderd werk-functioneren het werk-functioneren in relevante mate is verbeterd na drie en zes maanden. Na drie maanden is het werk-functioneren van 30% van de deelnemers van het EMH-PMO en 46% van de deelnemers van het bedrijfsarts-pmo in relevante mate verbeterd. Na zes maanden is dit 36% voor het EMH-PMO en 41% voor het bedrijfsarts-pmo. Deze verschillen tussen de strategieën zijn echter niet statistisch significant. Ook is onderzocht of het verschil in effect op werk-functioneren tussen de groepen een vooraf gedefinieerd criterium overschrijdt. Dit blijkt niet het geval, waaruit geconcludeerd kan worden dat het EMH-PMO het statistisch significant niet slechter doet dan het bedrijfsarts-pmo wat betreft werk-functioneren. Wat betreft het effect op psychische gezondheid is er gekeken naar de verandering in stress, werk-gerelateerde vermoeidheid en posttraumatische stress. Beide groepen verbeteren op deze uitkomsten, zonder significant verschil tussen de groepen. Wat betreft werkvermogen zijn beide groepen stabiel gebleven. In Hoofdstuk 6 wordt vervolgens het effect van het EMH-PMO vergeleken met de controlegroep. Ook in deze studie is in beide groepen een verbetering waargenomen in werk-functioneren, stress, werk-gerelateerde vermoeidheid en posttraumatische stress en zijn beide groepen stabiel gebleven wat betreft werkvermogen. Na drie maanden is 30% van de deelnemers in beide groepen relevant verbeterd met betrekking tot werkfunctioneren ten opzichte van het begin van de studie. Na zes maanden is dit 36% in het EMH-PMO en 28% in de controlegroep. Op geen van de uitkomstmaten zijn statistisch significante verschillen gevonden tussen de groepen. Echter, als wordt gekeken naar de gehele deelnemende groep van verpleegkundigen en paramedici (en niet alleen de deelnemers waarbij signalen van psychische problemen of verminderd werk-functioneren zijn gevonden), dan blijkt er wel een statistisch significant verschil te zijn tussen de groepen met betrekking tot werk-functioneren. De deelnemers van het EMH-PMO zijn tussen de meting na drie maanden en de meting na zes maanden verder op deze uitkomstmaat verbeterd, terwijl dit niet bij de controlegroep is waargenomen. 223

225 Samenvatting De uitval van deelnemers in dit onderzoek was vrij hoog. Bovendien was de deelname aan de aangeboden zelfhulp internetcursussen in het EMH-PMO erg laag. Omdat de controlegroep na afloop van het cluster-gerandomiseerd onderzoek het EMH-PMO aangeboden heeft gekregen, was het mogelijk om het effect van het EMH-PMO te onderzoeken in een grotere groep deelnemers (Hoofdstuk 7). Van 128 deelnemers zijn gegevens beschikbaar en zijn de effecten bepaald op werk-functioneren, stress en werkgerelateerde vermoeidheid, waarbij scores voorafgaand aan het EMH-PMO zijn vergeleken met scores drie maanden later. Dertig procent van de deelnemers is na drie maanden relevant verbeterd wat betreft werk-functioneren. Verder blijkt uit deze studie dat zowel werk-functioneren als werk-gerelateerde vermoeidheid significant verbeteren over de tijd. Stressklachten verminderen niet significant, maar in de groep van 26 deelnemers die heeft ingelogd in een zelfhulp internetcursus is een relevant maar klein effect gevonden op stress. Opvallend is dat deze subgroep slechter scoort op alle drie de uitkomstmaten, zowel voorafgaand aan het EMH-PMO als daarna, maar tevens een grotere verbetering over de tijd laat zien dan de gehele groep van 128 deelnemers. Wat is de kosteneffectiviteit m.b.t. werk-functioneren van twee verschillende strategieën voor een module voor Preventief Medisch Onderzoek gericht op de psychische gezondheid? Het EMH-PMO is niet kosteneffectief wat betreft werk-functioneren, omdat de kosten per extra deelnemer die relevant verbetert op werk-functioneren hoger zijn dan in de controlegroep. Het bedrijfsarts-pmo blijkt wel kosteneffectief met betrekking tot werkfunctioneren, aangezien deze strategie leidt tot een kostenbesparing ten opzichte van de controlegroep per extra deelnemer die relevant verbetert. Dit wordt geconcludeerd op basis van de bevindingen in Hoofdstuk 8. In dit hoofdstuk wordt de kosteneffectiviteitsanalyse beschreven met betrekking tot werk-functioneren zes maanden na de interventie, waarbij zowel het EMH-PMO als het bedrijfsarts-pmo zijn vergeleken met de controlegroep. Deze kosteneffectiviteitsanalyse is uitgevoerd vanuit maatschappelijk perspectief, wat betekent dat er geen onderscheid is gemaakt in wie welke kosten voor zijn rekening dient te nemen. Effecten zijn berekend door het percentage deelnemers te bepalen dat na zes maanden relevant is verbeterd wat betreft werk-functioneren. Het percentage relevant verbeterde deelnemers is 16% in het EMH-PMO, 24% in het bedrijfsarts-pmo en 20% in de controlegroep. Kosten zijn berekend door te kijken naar de kosten voor de interventie, directe medische kosten zoals voor het gebruik van medicijnen, directe niet-medische kosten zoals bijvoorbeeld reiskosten die worden gemaakt om naar een zorgverlener te gaan en indirecte niet-medische kosten, zoals de kosten voor ziekteverzuim of verminderde productiviteit op het werk. De gemiddelde kosten per deelnemer zijn in het EMH-PMO, in het bedrijfsarts- PMO en in de controlegroep. Van beide strategieën is de ratio van kosten en 224

226 Samenvatting effecten berekend ten opzichte van de controlegroep. Deze ratio wordt de incrementele kosteneffectiviteitsratio genoemd en kan worden geïnterpreteerd als de netto kosten per relevant verbeterde deelnemer. Hoewel de kosten voor het EMH-PMO lager zijn dan die voor de controlegroep, is het effect op werk-functioneren ook minder dan in de controlegroep. De mediaan van de incrementele kosteneffectiviteitsratio voor het EMH-PMO vergeleken met de controlegroep is Dat betekent dat een relevante verbetering van werk-functioneren van één deelnemer door middel van het EMH-PMO ruim vierduizend euro meer kost dan een relevante verbetering van werk-functioneren van één deelnemer in de controlegroep. De mediaan van de incrementele kosteneffectiviteitsratio voor het bedrijfsarts-pmo vergeleken met de controlegroep is , wat betekent dat een relevante verbetering van werk-functioneren van één deelnemer door middel van het bedrijfsarts-pmo ruim vijfduizend euro minder kost dan een relevante verbetering van werk-functioneren van één deelnemer in de controlegroep. Conclusies en aanbevelingen De studies die zijn uitgevoerd als onderdeel van dit proefschrift onderstrepen het belang om ondersteuning te bieden aan werknemers in de gezondheidzorg, om ervoor te zorgen dat zij gezond blijven in hun werk en optimaal blijven functioneren. Ten aanzien van het eerste doel van dit proefschrift kan worden geconcludeerd dat beginnende verpleegkundigen behoefte hebben aan kennis, psychosociale ondersteuning en fysieke onder - steuning om gezond en goed functionerend aan het werk te blijven. Verpleegkundig opleiders worden geadviseerd om een curriculumonderdeel te ontwikkelen voor verpleeg kundestudenten waarin aandacht wordt besteed aan de gezondheidsrisico s die het werk als verpleegkundige met zich meebrengt, de gevolgen die deze risico s kunnen hebben en middelen om deze gevolgen te voorkomen. Daarnaast worden bedrijfsgezondheidsdiensten geadviseerd om nieuwe werknemers in de zorg beter te introduceren in de wereld van arbeid en gezondheid, zodat werknemers weten waar zij hulp kunnen krijgen als zij problemen ervaren. Ten aanzien van onderzoek wordt aanbevolen om de gezondheid en het werk-functioneren van verpleegkundigen vanaf het begin van hun carrière te volgen door middel van een cohortstudie. Hiermee kan inzicht worden verkregen in voorspellers van werk-gerelateerde gezondheidsproblemen en verminderd werk-functioneren. Op die manier kan de ondersteuning van (beginnende) verpleegkundigen verbeterd worden, zodat zij gezond blijven en optimaal kunnen blijven functioneren in hun werk. Ten aanzien van het tweede doel van dit proefschrift kan worden geconcludeerd dat het niet wordt aanbevolen om een EMH-PMO gericht op de psychische gezondheid van verpleegkundigen en paramedici te implementeren, bestaande uit signalering van problemen in psychische gezondheid of werk-functioneren gevolgd door een gepersonaliseerde terugkoppeling en het aanbod om een zelfhulp internetcursus te volgen. 225

227 Samenvatting Wel wordt de implementatie aanbevolen van een PMO gericht op de psychische gezondheid bestaande uit signalering van problemen, een gepersonaliseerde terugkoppeling en een preventief consult bij de bedrijfsarts. Zelfhulp internetcursussen kunnen daarbij opgenomen worden in het interventieprotocol. Verder wordt geadviseerd om het PMO aan te vullen met modules gericht op de fysieke en algemene gezondheid van werknemers in de gezondheidszorg. Managers in de gezondheidszorg worden aanbevolen zich bewust te zijn van de effecten die gezondheidsproblemen kunnen hebben op het werkfunctioneren van werknemers, maar ook van de financiële voordelen die behaald kunnen worden door de gezondheid en het werk-functioneren van werknemers in de gezondheidszorg te volgen en te verbeteren. Voor toekomstig onderzoek naar preventieve interventies in de bedrijfsgezondheidzorg wordt aanbevolen om uitgebreid aandacht te besteden aan de context waarbinnen een interventie wordt geëvalueerd maar ook de haalbaarheid van die interventie, alvorens over te gaan tot een evaluatie van de (kosten)- effectiviteit in een gerandomiseerd gecontroleerde studie. Ten slotte wordt geadviseerd om werk-functioneren als uitkomstmaat mee te nemen in de evaluatie van preventieve interventies die worden ingezet in een werkomgeving. 226

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