National trial to test strategies to improve medication compliance in a community pharmacy setting

Transcription

1 National trial to test strategies to improve medication compliance in a community pharmacy setting Researchers: Dr Anne-Marie Feyer, PricewaterhouseCoopers Professor SI (Charlie) Benrimoj, University of Sydney Carrie Schulman, PricewaterhouseCoopers Rebecca Jessop, PricewaterhouseCoopers Deanna Pyper, PricewaterhouseCoopers Brian Sabet, PricewaterhouseCoopers Mary Mitchelhill, PricewaterhouseCoopers FULL FINAL REPORT THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT

2 Acknowledgement PricewaterhouseCoopers would like to thank the Department of Health and Ageing for funding this project as part of the Fourth Community Pharmacy Agreement, which has been administered by the Pharmacy Guild of Australia. The researchers would like to make special thanks to the pharmacies, pharmacists and patients who participated in this trial without whom this report would not have been possible (see Appendix A). Thanks are also warranted to both the project s Pharmacy Reference Group and Advisory Groups who helped finalise some of the trials design and participated in workshops and discussions with participating pharmacies throughout the trial. This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report. The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild. FULL FINAL REPORT THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT

3 Project team Lead researchers Dr Anne-Marie Feyer, PricewaterhouseCoopers Professor SI (Charlie) Benrimoj, Faculty of Pharmacy, University of Sydney Quality and assurance partner John Cannings, PricewaterhouseCoopers Project director Carrie Schulman, PricewaterhouseCoopers Project managers Rebecca Jessop, PricewaterhouseCoopers Mary Mitchelhill, PricewaterhouseCoopers Research team Deanna Pyper, PricewaterhouseCoopers Brian Sabet, PricewaterhouseCoopers Jeremy Solomon, PricewaterhouseCoopers Elle Feletto, Faculty of Pharmacy, University of Sydney Data management team Monica Brabant, PricewaterhouseCoopers Michael Allwright, PricewaterhouseCoopers 1

4 Acronyms Acronym AGPN APCC BMQ CI CPS CPD DAA DoHA EOI GP Guild HMR IT KSA MUR MARS NSW NT PhARIA PSA PwC QLD RCT SD SEIFA SA TAS USA VIC WA Explanation Australian General Practice Network Australian Primary Care Collaborative Beliefs about Medications Questionnaire Confidence Interval Cognitive Pharmaceutical Services Continuing Professional Development Dose Administration Aids Department of Health and Ageing Expression of interest General Practitioner Pharmacy Guild of Australia Home Medicines Review Information technology Knowledge, skills and abilities Medication Use Reviews Medication Adherence Report Scale New South Wales Northern Territory Pharmacy Access/Remoteness Index of Australia Pharmaceutical Society of Australia PricewaterhouseCoopers Queensland Randomised controlled trial Standard Deviation Socio-Economic Indexes for Areas South Australia Tasmania United States of America Victoria Western Australia 2

5 Table of contents 1. Background and rationale for the research Project background Definition of medication compliance The impact of non-compliance Health impacts of non-compliance Economic costs of non-compliance Measures of compliance Predictors and barriers of non-compliance Improving medication compliance Strategies for improving medication compliance Behaviour change Behaviour change in community pharmacies Rationale for the research Purpose of the research Research project outline Purpose of the report Roadmap to the report Approach to the design of the trial Background Committee consultations Advisory Panel Reference Group Community Pharmacy Working Group Literature review Search strategy Literature search criteria Stakeholder consultation Purpose of stakeholder consultations Key stakeholder groups and organisations Themes from stakeholder consultations Trial design Guiding principles of the study An evidence-based approach Practical adult learning theory Organisational change

6 3.2. Overview of the four-stage patient intervention Stage 1: Sign up for the trial Stage 2: Explore medication taking behaviour Stage 3: Collaborate and commit to next steps Stage 4: Follow through Reimbursement of pharmacists Timeframes for the research project Ethics approval Pilot Objectives of the pilot Pilot approach Pharmacy recruitment to the pilot Pharmacy education Patient recruitment Intervention, data collection and support Key findings of the pilot Pilot conclusions Trial methodology Overview of trial activities and timelines Sampling framework Development of the pharmacy sampling framework for the national trial Patient distribution Recruitment process Pharmacy recruitment process Pharmacy recruitment Education and training of pharmacists Education workshops Site visits and teleconference education Patient recruitment Pharmacy resources, support and communication Pharmacy resources Additional pharmacy support Pharmacy communication Pharmacy data collection Pharmacy demographic survey Pharmacy survey Patient data collection Patient characteristics questionnaire Patient questionnaire Patient strategy card

7 Patient satisfaction questionnaire Data management processes Access database Data quality Statistical analysis Results Recruitment and retention Pharmacy recruitment and retention Patient recruitment and retention Missing and excluded data Demographics Pharmacy demographics Patient demographics Baseline results Medication compliance Beliefs about medication and readiness to change Trial outcomes Compliance measure outcomes Beliefs about medication outcomes Readiness to change outcomes Characteristics associated with improved outcomes Pharmacist education Strategies delivered by pharmacists Pharmacist satisfaction Education satisfaction End of trial satisfaction Impact of the trial Pharmacy readiness Patient satisfaction Completers vs. non-completers Comparison of pharmacy completers vs. non-completers Comparison of patient completers vs. non-completers Reasons for patient drop-out Economic Analysis Service delivery costs Service establishment costs Honorarium costs Estimated total cost per patient Effectiveness of the intervention Benefits of the intervention

8 7. Implementation of a national medication compliance service in community pharmacy: Implications of the national trial Key findings of the medication compliance service Strengths and limitations of the Study Recommendations Recommendations emerging from an evidence-based approach Recommendations emerging from practical use of adult learning theory Recommendations emerging from Organisational Change theory Recommendations emerging from behaviour change theory Conclusion

9 1. Background and rationale for the research 1.1. Project background Non-compliance with medication regimens is a challenging and complex problem, resulting in poorer health outcomes and increased health care costs. Recent literature on medication compliance within Australia reveals that approximately 50% of patients fail to comply with their medication regimen (Pharmaceutical Society of Australia, 2006). These findings are consistent with those found internationally. A review on medication compliance in the United States of America (USA) revealed that 50-70% of patients do not comply with their prescribed medication (Wertheimer & Santella, 2003). This problem is further exacerbated by the fact that medication non-compliance is a hidden problem, often undisclosed by patients and unrecognised by prescribers. To further investigate this complex problem, the Pharmacy Guild of Australia (the Guild) engaged PricewaterhouseCoopers (PwC) in collaboration with the University of Sydney, to undertake a study to develop and evaluate strategies implemented in community pharmacies to improve medication compliance (the Improving Medication Compliance Trial). This project was funded by the Australian Government Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement Research and Development program managed by the Guild. The focus of this project was to develop and implement a professional service in community pharmacies that aimed to improve a patient s medication compliance. This section provides an overview of the Improving Medication Compliance project, including: definitions of medication compliance impact and costs of medication non-compliance measures of medication compliance predictors and barriers to compliance rationale for the research aims and objectives of the study Definition of medication compliance Medication compliance is a term used to describe the extent to which a patient s behaviour matches agreed recommendations from the prescriber (Cochrane, 1996). In reviewing the literature, it is evident that medication compliance is often used interchangeably with adherence and concordance (Playle & Keeley, 1998). It is recognised that many health researchers use the term adherence in preference to compliance; however the term compliance will be used throughout this report. Figure 1 illustrates the pathway for non-compliance, highlighting the difference between primary and secondary non-compliance, as well as intentional and unintentional non-compliance (Pharmaceutical Society of Australia, 2006). Primary non-compliance refers to patients who do not initially fill their prescription. Secondary non-compliance refers to patients who, after initially filling their prescription, fail to repeat, refill or take this medication correctly. It is secondary non-compliance that pharmacists may have the greatest impact on. 7

10 Figure 1: The non-compliance pathway Decision to prescribe Patient receives the advice/ recommendation to use a given Rx Prescription not filled PRIMARY NON-COMPLIANCE Prescription filled The initial prescription is filled by the patient Not refilled SECONDARY NON-COMPLIANCE Not taken SECONDARY NON-COMPLIANCE INTENTIONAL NON-COMPLIANCE UNINTENTIONAL NON-COMPLIANCE INTENTIONAL NON-COMPLIANCE UNINTENTIONAL NON-COMPLIANCE The literature examines both intentional and unintentional non-compliance. Intentional non-compliance involves a well thought out, purposeful decision to omit or cease to take a medication dose, for example based on the patients beliefs about medication or their disease. Unintentional non-compliance involves patients omitting to take a medication, for example as they are away from home and do not have access to their medications or simply forget to take their medication (Pharmaceutical Society of Australia, 2006). Research has shown that approximately 40% of non-compliant patients are unintentionally non-compliant (Vik, Maxwell, Hogan, Patten, Johnson, & Romonko-Slack, 2005) The impact of non-compliance Patient non-compliance to medication regimens has many implications for both the individual patient and the health care system (Aslani, Krass, Chen, Whitehead, & Rose, 2006), in terms of health outcomes and economic costs Health impacts of non-compliance Poor compliance to medication regimens compromises the effectiveness of treatments, increases the risks of complications and reduces a patients quality of life (World Health Organisation, 2003). In a review of asthma literature (World Health Organisation, 2003), poor compliance resulted in a more intense relapse of symptoms, resistance to therapies and decreased quality of life for the patient. Similar results have been demonstrated in studies investigating hypertension. One such study (Psaty, 1990) found that patients who stopped using beta-blockers were 4.5 times more likely to experience complications for coronary heart disease than those who complied with the medication. This research demonstrates the importance of enhancing patients compliance with medication regimens to improve their health outcomes. According to several recent literature reviews (Haynes, H, Garg, & Montague, 2005; Horne, Weinman, Barber, Elliott, & Morgan, 2005) increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments. 8

11 Economic costs of non-compliance The economic costs of non-compliance are high both in Australia and internationally. In a report by the Australian Council for Safety and Quality in Health Care (2002), inappropriate use of medicines cost the Australian public hospital system approximately $380 million per year. Furthermore, a study (Dartnell, Anderson, Chohan, Galbraith, Lyon, & Nestor, 1996) found that the cost of hospital admissions in Australia, which were attributable to non-compliance, was approximately $1 million per year. International literature is in line with these findings, for example it is estimated that the impact of noncompliance on healthcare costs in the USA alone is between US$77 and US$300 billion a year and contributes to approximately 25% of hospital admissions (Ashburn, 1981). The literature on medication compliance highlights the dramatic consequences of non-compliance. Efforts to assist patients to improve their compliance with medication regimens represent an opportunity to improve population health and the efficiency of the health care system. The importance of improving medication compliance is further recognised in the National Medicines Policy, where quality use of medicines is one of the central objectives Measures of compliance Tools for measuring patient medication compliance are important for identifying patients who are noncompliant and may require assistance to improve their medication taking behaviour. Accurate information about compliance is needed to be able to apply a patient centred, targeted approach to the implementation of strategies to improve compliance (Svarstad, Chewning, Sleath, & Claesson, 1999). From the literature, it is recognised that no single method is considered to be completely valid and reliable. It is important therefore, to use multiple methods, ie a variety of compliance indicators / tools to enable measurement of the different dimensions of medication compliance. Measures of compliance can be categorised as either direct or indirect measures. Direct measures refer to those measures of compliance which observes the ingestion of the medication, whereas indirect measures refer to assumed ingestion based on self-report or monitoring (Horne et al., 2005). Table 1 provides an overview of the different measures of compliance identified from the literature. Table 1: Measures of indirect medication compliance Description Advantages Disadvantages Electronic monitoring devices Electronic monitoring devices, such as the Medication Events Monitoring System, involve dispensing each patient s medication in a bottle that contains a microprocessor in the cap to record the date and time of each bottle opening. MedsIndex MedsIndex calculates a score out of 100 based on the number of missed doses a client may have had in the given time period as indicated from dispensing data. The lower the MedsIndex score the lower the patient s assumed medication compliance (see Section for more detail on MedsIndex). Most accurate indirect measure of compliance available Often considered the gold standard in measuring adherence Allows pharmacists to approximate whether a patient has been taking their medications Expensive Does not ensure medication ingestion Does not provide information about why the patient did not take their medication MedsIndex is not compatible with all dispensing databases within community pharmacies. Some reliability concerns exist related to changes in medication and dispensing at other pharmacies. 9

12 Description Advantages Disadvantages Patient self-report A number of validated self-report scales have been used to measure medication compliance and beliefs about medication including the Medication Adherence Rating Scale (MARS) and the Beliefs about Medication Questionnaire (BMQ). Less expensive Provides details about why a patient did not take their medication More practical measure Self report bias 1.5. Predictors and barriers of non-compliance Medication compliance for long-term regimens is a complex and multidimensional process. It is influenced by a variety of factors related to the patient, disease, therapy, socio-economic status and the health care system (Playle & Keeley, 1998). These factors are further complicated by the variability of medication-taking behaviour over time. The barriers and predictors of non-compliance have been examined extensively in the literature. Considerable overlap exists in the findings for both of these concepts and this report differentiates them based on the way the factors are reported and measured in each study. Predictors refer to those factors that have been statistically tested and found to be significantly related to non-compliance. Barriers are identified through qualitative methods and have not been statistically verified. Predictors and barriers can be further categorised into fixed and modifiable factors. Fixed factors refer to characteristics of the patient that cannot be changed but provide important contextual information regarding risk factors of non-compliance. Fixed factors include patient demographics, such as age, gender, race and socio-economic status, illness and medication history and impaired cognitive function. Modifiable factors can be used to inform the design of strategies for improving medication compliance. The key modifiable barriers to medication compliance identified in the literature are: medication complexity patient, pharmacist and prescriber relationship patient health and medication beliefs and understanding of their illness and treatment access to pharmacists and health care providers side-effects of medication forgetting to take medication. 10

13 1.6. Improving medication compliance Strategies for improving medication compliance The findings from the literature review suggest a number of strategies which could be integrated into community pharmacy practice to improve a patient s medication compliance. Key strategies identified for possible use in the community pharmacy setting include: provision of patient education and information reminders and dose administration aids follow up provision of pharmacist education and information medication profiling and simplification of medication regimens collaboration between patient, pharmacist and physician and pharmacy remuneration. See the literature review in Appendix C for a detailed review of these strategies and their impact on medication compliance Behaviour change In addition to the evidence-based and best practice strategies, a community pharmacy compliance service should be based on relevant behaviour change theories and models. Compliance to medication is a variable behaviour, and thus improving poor compliance relies on changing that behaviour. For example, behaviour change research suggests that patient motivation and readiness to change greatly influences the way a patient takes their medication. To help patients improve their medication compliance, it is important to identify and understand the patient s readiness or motivation to change their behaviour (Rollnick, Mason, & Butler, 1999). Figure 2 illustrates the Stages of Change model, which can be used to identify a patient s readiness to change. In this model, patients are shown to move through five stages when trying to change their behaviour: pre-contemplation; contemplation; preparation; action; and maintenance. Figure 2 demonstrates how people move through the stages in a cyclical manner (Rollnick et al., 1999). Figure 2: Stages of change model Exit Relapse Pre-Contemplation Contemplation Maintenance Action Preparation 11

14 Research has shown that a patient will be more ready to change their behaviour if they feel the change is important and they have the confidence that they can do it. Figure 3 illustrates how importance and confidence interact to determine an individual s readiness to change. Figure 3: Importance and confidence to change High Ready Importance Low High Confidence The research on behaviour change suggests that influencing patients medication taking behaviour relies on community pharmacists delivering a patient-centred and tailored approach to meet the individual needs of patients. A multi-component intervention, combining numerous strategies, may therefore be more effective than implementing a single strategy. This recommendation is supported by several literature reviews, including Haynes, Garg and Montage (2005) and McDonald, Garg and Haynes (2002) Behaviour change in community pharmacies The successful delivery of a medication compliance professional service relies on the readiness of pharmacists to change their behaviour. In this setting, readiness to change refers to an organisation s plan for change and its ability to execute it (Roberts, Benrimoj, Dunphy and Palmer, 2007). This readiness to change begins with the pharmacist s perceptions of the benefits of change, the risk of failing to change and the demands of an externally imposed change. Applying Rollnick et al s (1999) model of health behaviour change, pharmacists need to assess the need for the change (importance) and have the resources such as time and skill (confidence) to effectively carry out the change Rationale for the research The community pharmacy profession is in the midst of a significant transformation, shifting the focus of pharmacists away from solely supplying products towards the implementation of professional services. This shift is evidenced by the increasing literature (Roughhead, Semple, & Vitry, 2002) identifying community pharmacists as important members of the clinical service provider team in improving medication compliance, as well as the value of Cognitive Pharmaceutical Services (CPS). CPS, often referred to as Pharmaceutical Care, is defined as clinical and professional assistance delivered by the community pharmacist, for the purpose of promoting effective and safe medication taking behaviour (Albrecht, Roberts, Benrimoj, Williams, Chen, & Aslani, 2006). CPS focuses on providing patient-centred care to improve health service delivery to patients. 12

15 Community pharmacists are well placed to improve medication compliance, as they: are often the last point of contact after patient consultation with a physician and they can play an important role in reinforcing information and correcting misunderstandings (Crawford, 2008; Denham & Barnett, 1998) have extensive pharmaceutical knowledge and can assist patients with medication related concerns are more easily accessible than physicians, with patients not requiring an appointment work in an informal atmosphere, facilitating trusting relationships and allowing patients to ask more questions and express their concerns (Knight, 2000) provide an advanced level of care by identifying and implementing existing resources, such as dose administration aids (Pharmaceutical Society of Australia, 2006). Pharmacists are ideally positioned and skilled to provide a CPS which focuses on improving medication compliance (Aslani et al., 2006). An investigation of the effectiveness of a professional pharmacy service for improving patient medication compliance is therefore a critical step to implementing a valuable and remunerable pharmacy delivered compliance service (Aslani et al., 2006) and to support a national rollout Purpose of the research The purpose of the research project was to develop, implement and evaluate a professional service in the community pharmacy which aimed to improve a patient s medication compliance. The research was based on the implementation of a professional pharmacy service in community pharmacy, in addition to patientrelated health outcomes that relate to the implementation of the service. The objectives of the research were to: improve medication compliance among users of regular medicines facilitate the implementation of a professional pharmacy service for medication compliance provide the Guild with a implementation considerations and recommendations to support a national rollout. Based on the objectives, two hypotheses were developed: 1. That an effective compliance service can be developed and implemented in the community pharmacy setting 2. That a significant improvement in patient compliance will be seen as a result of the pharmacist intervention. 13

16 1.9. Research project outline The Improving Medication Compliance research project consisted of six stages: Stage 1: Project initiation included liaison with the Guild, Advisory Panel and committees and a comprehensive literature review. Stage 2: Strategy development included key stakeholder consultation, trial design and ethics approval. Stage 3: Conduct pilot involved piloting the medication compliance service and implementation of the intervention. Stage 4: Trial implementation the implementation of the medication compliance trial. Stage 5: Trial analysis. Stage 6: Final report and implementation considerations. An outline of the research project is illustrated in Figure 4. Figure 4: Outline of the research project Stage 1: Project initiation 5 weeks Literature review Identification of reliable predictors and barriers to medication compliance, and evidence based strategies for improving medication compliance. September 2008 Stage 2: Strategy development 2 month Trial design Stakeholder consultations conducted to design and agree trial design and intervention. Ethics approval Ethics approval obtained from University of Sydney. October 2008 Stage 3: Conduct pilot 3 months Pilot Implementation of the two month pilot for testing and selection of interventions for use in the trial January 2009 Stage 4: Trial implementation 6 months Recruitment of pharmacies 132 pharmacies expressed interest, with 91 pharmacies successfully consenting. Of this, 66 pharmacies successfully completed the trial. May 2009 Recruitment and training of pharmacies 93 pharmacies were represented at the education workshop. 97 pharmacies received a site visit or a teleconference Recruitment of patients Pharmacists were responsible for recruiting patients to the trial. Data collection Patient data was collected at baseline (zero months), mid point (three months) and end point (six months). Stage 5: Analyse trial results 2 months Analysis of trial results Cost / benefit analysis & business case January 2010 Stage 6: Final report 2 months Final report and recommendations for national implementation Recommendations made regarding appropriate and effective service delivery models Feb/Mar 2010 April

17 1.10. Purpose of the report This is the Full Final Report for the Improving Medication Compliance research project. This report comprises the Executive Summary, the Full Final Report (this report) and Appendices (attached). The primary purpose of the Full Final Report is to present a comprehensive and detailed description of the approach and findings of the research project, along with all necessary technical details to substantiate the rigour of the project Roadmap to the report The final report is comprised of eight sections, including the executive summary: Section 2 provides the background to the project and rationale for the research, including the objectives and hypotheses of the study. Section 3 provides the approach to the design of the trial, including the committees, literature review and consultations conducted to inform the development of the trial. Section 4 provides a detailed description of the trial design, including the four-stage patient intervention, pharmacy reimbursement, timeframes and ethics approval. Section 5 provides an overview of the pilot, including key findings which informed the national trial. Section 6 provides the detailed description of the trial methodology, including the approach to recruitment and selection, education and training, data collection and data analysis. Section 7 provides the key findings and results from the trial, as well as the results from the economic analysis. Section 8 provides a discussion of the key findings from the trial, as well as important considerations, study limitations and study conclusions. 15

18 2. Approach to the design of the trial 2.1. Background The project initiation (Stage 1) and strategy development stage (Stage 2) of the research project consisted of three key activities, which guided the design of the Improving Medication Compliance Trial (the trial). These included: consultation with three advisory committees, including the Advisory Panel, Reference Group and Community Pharmacy Working Group a comprehensive literature review key stakeholder consultations Committee consultations Advisory Panel The Advisory Panel was established to provide a representative group of key stakeholders to oversee the implementation of medication compliance strategies into the community pharmacy. Member representation consisted of the Guild, Pharmaceutical Society of Australia (PSA), Australian General Practice Network (AGPN), Australian Psychological Society, Department of Health and Ageing (DoHA) and the Consumer s Health Forum. The role of the Advisory Panel was to: oversee the project from all aspects of member representation act as an advisor to the project on behalf of the Guild review aspects of the project on commencement, as the project progressed and on completion. Four Advisory Panel meetings were held in November 2008, April 2009, August 2009 and March The members of the Advisory Panel are provided in Table 2. Table 2: Advisory Panel members Name Toni Riley Paul Feldman Gilbert Yeates Dr Helen Lindner Dr Guan Yeo Roma Cecere Alison Marcus Organisation Pharmacy Guild of Australia Department of Health and Ageing Pharmaceutical Society of Australia Australian Psychological Society Australian General Practice Network Healthlinks Consumers Health Forum 16

19 Reference Group The Reference Group consisted of key pharmacy and healthcare provider experts and was established to provide additional support and guidance regarding the research methodology and strategies. The role of the Reference Group was to: act as a multi-disciplinary expert resource for the project team review and advise on pilot and trial implementation assist in recruitment of pharmacies to the pilot and trial review and advise on analysis, findings and major deliverables throughout the project provide advice regarding barriers to the delivery of a community pharmacy professional services program for medication compliance and the implementation of a national program. Four meetings of the Reference Group were held in September 2008, December 2008, April 2009 and April See Appendix B for the list of members and terms of reference Community Pharmacy Working Group The Community Pharmacy Working Group consisted of a representative group of local practising community pharmacists and was established to provide practical advice on the operational aspects of implementation of a medication compliance service into community pharmacies and other associated activities, such as recruitment and use of MedsIndex. The role of the Community Pharmacy Working Group was to: provide practical advice and a deep understanding on the operational aspects of delivery of a community pharmacy professional service for medication compliance meet at key stages to provide practical advice for recruitment, implementation, behaviour change, and interpretation of findings in a community pharmacy setting participate in the pilot and/or trial and act as local champions in each state to provide local advice and support to the participating pharmacists. Two meetings of the Community Pharmacy Working Group were held in December 2008 and April See Appendix B for a list of members and terms of reference Literature review This section outlines the literature review methodology that was used as part of the research design. The literature review was undertaken to: identify reliable predictors of non-compliance and examine the reasons behind poor medication taking behaviours examine models of behaviour and factors that influence behaviour change and a patient s readiness to change, to improve compliance with medications review strategies for improving medication compliance examine the role of the community pharmacists in delivery of a compliance service and the ability of these services to be integrated into the community pharmacy setting. 17

20 The literature review methodology ensured that the literature was identified that could best inform the design of the trial according to an explicit search strategy, using defined literature search criteria Search strategy The literature search strategy included examination of both peer reviewed journals and other published literature. The following approaches were used to identify relevant literature: Electronic database search Medline, CINAHL, PsycINFO, ScienceDirect, Pubmed, Web of Science, The Cochrane Library and CIAP databases were searched using the terms listed in Table 3. Internet searches A number of medication and compliance websites were searched, including the Guild, DoHA and the Australian Institute of Health and Welfare. Other search engines including Google and Google Scholar were also search using a variety of the common key words. Scanning of reference lists The reference lists of articles and reports obtained through the above databases and search engines were scanned to identify other potentially relevant literature Literature search criteria The literature search involved a detailed examination of the material that had been identified using the subject and text words listed in Table 3. Table 3: Keywords used during database search Keyword search criteria: medication compliance Keyword search criteria: barriers Keyword search criteria: predictors Keyword search criteria: behaviour change Adherence, cognitive pharmaceutical service, compliance, community pharmacist, concordance, cost, cost-benefit, cost-effectiveness, cost-of-illness, health-care, medication management, medication regimen, patient, pharmaco-economics, treatment. Barriers, barriers to change, barriers to compliance, change management, community pharmacy service, (compliance OR adherence OR concordance), (compliance OR noncompliance OR non-compliance), cost-effectiveness, costbenefit, health care, medication management, patient, pharmaceutical care, predictors. Cognitive pharmaceutical service, (Compliance OR adherence OR concordance), (compliance OR noncompliance OR non-compliance), health care, intervention, medication, medication regimen, patient, pharmacy, pharmacists, strategies. Behaviour change, medication behaviour, medication taking behaviour, health behaviour, heath prevention, health promotion, stages of change, change models, theory of change, trans-theoretical model, health belief model, changing health behaviour, compliance, adherence behaviour, medication beliefs, patient activation, self-efficacy. Key findings of the literature review are summarised in the Background and Rationale for the Research discussion in Section 2 above. The complete literature review is included in Appendix C. 18

21 2.4. Stakeholder consultation Stakeholder consultations were conducted with key groups and individual stakeholders who were identified as integral to informing the design of the Improving Medication Compliance trial, maximising participation in the trial, and thereby increasing the opportunity for success Purpose of stakeholder consultations The purpose of the stakeholder consultations were to: allow stakeholder groups to be consulted, informed and engaged in the research project incorporate the potential roles and needs of the stakeholder groups in the study design gather input on the trial design and receive feedback on implementation considerations identify and understand key success factors for the long term viability of the service Key stakeholder groups and organisations Two stakeholder workshops were held in Canberra and Melbourne during October Stakeholders who were unable to attend either of the workshops were individually consulted, either via telephone or face-toface interviews. The following are a list of organisations and stakeholder groups who were involved in the consultation workshops and interviews: Department of Health and Ageing The National Prescribing Service Medicines Australia AGPN Divisions of General Practice PSA Australian Medical Association National Heart Foundation Carers Australia National Asthma Council of Australia The Royal College of Nursing Australian Practice Nurses Association Community pharmacists Themes from stakeholder consultations Several key themes and considerations for the trial design were identified during the consultations, as described in Table 4. 19

22 Table 4: Key themes and considerations identified during stakeholder consultations Themes Importance of collaboration and communication Need for simple and consistent messages Focus on patient centred medication compliance strategies Workforce issues Support for pharmacists Impact of information technology (IT) systems Impact of generic medications Engaging GPs Impact of rural and remote locations Considerations To improve medication compliance, there needs to be collaboration and clear communication across all members of the health care team. Providing a team care orientated approach is essential to the success of compliance interventions including patients, General Practitioners (GP), pharmacists, carers and family. Given the number of projects focusing on improving medication compliance being run by the Guild, it is important that the messages delivered to patients, GPs and pharmacists are clear, simple and consistent to reduce confusion. The patient is the most important person and thus compliance strategies must be patient centred. This includes educating patients about the importance and benefits of medication compliance as well as ensuring that the patients are part of the team. Trial design needs to consider workforce issues including available time and staff, appropriate space and adequate training. The trial must be workable and fit into both the pharmacists and GPs everyday practice. Sufficient support needs to be provided to community pharmacists participating in the Improving Medication Compliance trial in order for them to provide an effective and efficient service. This includes appropriate and easy to access remuneration, education and training, timely and regular feedback and general support. Improving medication compliance in the community pharmacy setting relies on accurate and fast IT systems. Consideration needs to be given to IT which supports pharmacists in delivering a medication compliance service. Generic medication may complicate the use of medicines and increase the chance of confusion and misuse. To ensure GPs are appropriately engaged in the research project, continued information and collaboration throughout the project is essential. There are a number of additional barriers for those in rural and remote locations. These include language and cultural barriers, difficulty accessing pharmacies and lack of transport. The findings of the consultations with advisory committees, literature review, and key stakeholder consultations formed the basis of the design of the pilot and trial as described in the following section of this report. 20

23 3. Trial design The medication compliance service trialled in this study was underpinned by four key theoretical principles. These principles, through the activities undertaken in Stage 1 and Stage 2 of the research project informed the design and implementation of the intervention. This section describes: the guiding principles of the study the integrated patient and pharmacy intervention the four-stage patient intervention: Stage 1: Sign up for the trial. Stage 2: Explore medication taking behaviour. Stage 3: Collaborate and commit to next steps. Stage 4: Follow through the reimbursement of pharmacies for participation timeframes for the research project ethics approval Guiding principles of the study An evidence-based approach The medication compliance service was designed based on a systematic review of current literature, using what was known about compliance, behaviour change, organisational change and pharmacy-based professional services. Both the pharmacy and patient interventions were based on empirical data feedback loops, whereby information from the literature, key stakeholder interviews, Advisory Panel and the experiences of pharmacists in the pilot, informed the development and subsequent modification of the interventions. The patient compliance intervention was informed by the professional expertise of the community pharmacist, a focus on customising the intervention to the individual patient, and the systematic collection and review of data to inform future modifications in strategies Practical adult learning theory Key principles of adult learning theory were used in the design of the education workshops and the implementation of the medication compliance service in community pharmacies. The workshops were designed as train-the-trainer sessions with at least two pharmacy staff attending for follow up reinforcement. Information in the workshops was delivered using multi-sensory learning to cater for the different learning styles of participants through a combination of oral and visual didactic lecture style training, interactive demonstrations and role plays supported by written workbooks. Training included information delivered by peer champions on the benefits to the participating pharmacy both in terms of the professional difference made in the lives of their patients, patient loyalty and the financial returns to the pharmacy. These champions had been part of the pilot phase and were therefore able to share their experiences. Reinforcement of training was done via site visits to the pharmacy by the research team, phone follow up and feedback. The use of adult learning theory was important to the initial engagement of community pharmacists. 21

24 Organisational change Successful implementation of the medication compliance service relied upon the integration of key organisational change principles. The key principles of organisational change which informed the design and implementation of the community pharmacy medication compliance service, as trialled in this study, included: A whole of pharmacy approach. Consideration of the unique organisational and job design of each pharmacy, including management support and informal leadership by pharmacy representatives responsible for delivery of the service. Customising the compliance service to suit the processes and systems in each pharmacy, eg customising training to the dispensing software and utilising existing systems and processes for the follow up of patients. Providing practical tools, such as streamlined forms and carbonless copies for record-keeping. Providing multiple modes of communication, including a toll free phone line, dedicated fax number, website, teleconferences and monthly newsletters between the pharmacies and the training organisation. Creating feedback loops through affirmative communication, reminders by exception for missing data, and celebrating success. Behaviour change Principles and theories of stages of behaviour change were fundamental, both to engaging with busy pharmacists to change their interactions with clients, as well as understanding and changing patient behaviour to improve patient outcomes in compliance. Achieving behaviour change requires an understanding of the pharmacists and patients stage of change, their readiness and motivation to change and then the development of a targeted approach appropriate for that individual. Given the importance of behaviour change at both the patient and pharmacy level, the national trial was comprised of two integrated but distinct interventions, illustrated in Figure 5. The key activities of the pharmacist intervention are discussed in Section 5. Figure 5: Patient and pharmacist interventions IMPROVED COMPLIANCE Stage 1 Sign up Sign up for the Trial Patient intervention Stage 2 Explore Explore medication-taking behaviour and attitude Stage 3 Collaborate Collaborate and commit to next steps Stage 4 Follow through Follow through Record the patient s Pharmacist Intervention Pharmacy recruitment and selection Ongoing support and reinforcement Pharmacist training and education Delivery of patient intervention 22

25 3.2. Overview of the four-stage patient intervention Figure 6 overviews the steps undertaken in the four stages, further detail on each of the stages is provided below. Figure 6: Overview of the four stage process Stage 1 Sign up Sign up for the Trial Review dispensing database and identify patients using MedsIndex Contact identified patient and provide them with information about the trial Confirm that patient is willing to participate Get patient consent signed Stage 2 Explore Explore medication-taking behaviour and attitude Introduce questionnaire and provide guidance to patient on how to complete the questionnaire Discuss with the patient their reasons for not taking their medication as prescribed Use motivational interviewing to build rapport, clarifying and confirm, encourage open dialogue and listen to responses Stage 3 Collaborate Collaborate and commit to next steps Invite the patient to come up with a strategy Based on listening consider the patient s stage of change readiness Discuss options with patient and ask about their confidence to follow through continue until a strategy is agreed in which the patient expresses confidence Assist patient in completing the Reminder card Stage 4 Follow through Follow through Record the patient s estimated stage of change on the Strategy card and return all paperwork to the PwC researchers. Complete summary letter and send to GP (if agreed in consent) Set up reminder flags in system Execute patient reminders The timeline of the four-stage patient intervention is illustrated in Figure 7. Figure 7: Timeline for the four-stage patient intervention Stage 1 Onwards Start 3 months 6 months 23

26 Stage 1: Sign up for the trial In Stage 1, pharmacists were required to identify patients who were non-compliant with their long-term medication regimens, make contact with these patients to inform them of and obtain their consent to the trial. The key activities and tools for Stage 1 are outlined in Table 5 below. Table 5: Actions and tools for stage one Activity Description Tools 1 GP Letter Pharmacists had the option to send the GP information letter to their top prescribers in the area. This was an optional step, based on the outcomes of the pilot, discussed in Section 4. 2 Identify eligible patients 3 Inform patients of trial 4 Obtain patient consent Pharmacists identified patients who were eligible to participate in the trial through a review of their dispensing database using the MedsIndex software program (see Section for more details on MedsIndex as the measure of compliance). A benchmark MedsIndex score of less than or equal to 85 was used to identify patients to recruit to the trial. Pharmacists made contact with the identified patient, either proactively or opportunistically as they presented to the pharmacy. Patients were informed of the trial and invited to participate. Once the patient indicated their willingness to participate, the pharmacist obtained informed consent from the patient. GP information letter (Appendix D) MedsIndex Patient information letter (Appendix E) Patient consent form (Appendix E) Stage 2: Explore medication taking behaviour In Stage 2, pharmacists were required to explore patients attitudes and medication-taking behaviours, using motivational interviewing, including the reasons for not taking their medication as prescribed. In this stage, pharmacists were expected to use the knowledge obtained from the pharmacy education (see Section 5.4 for details on pharmacy education) to identify barriers to medication compliance and identify the patient s stage of behaviour change. The key activities and tools for Stage 2 are outlined in Table 6. Table 6: Actions and tools for stage two Activity Description Tools 1 Patient completes questionnaires 2 Discuss patient s medication taking behaviour 3 Assess patient s stage of change After patient consent, the patient completes the patient characteristics form and patient questionnaire (see Section 5.8 for more details on the data collection forms). The pharmacist discussed with patients their reasons for not taking their medications as prescribed, to identify barriers to medication compliance. Pharmacist identified and began to understand the patient s readiness or motivation to change their behaviour. Patient characteristics form and questionnaire (Appendix F) Not applicable Stages of change (see Section 1.6.2) 24