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1 HOMECARE Clinical Continuity by Integrated Care Grant Agreement No Integrated home care for patients with stroke in Portugal: impact on patient functionality April 2012 Silvina Santana 1
2 2
3 Title Integrated home care for patients with stroke in Portugal: impact on patient functionality Author: Silvina Santana Institute of Electronics Engineering and Telematics of Aveiro Department of Economics, Management and Industrial Engineering Research Unit in Governance, Competitiveness and Public Policies Publisher: University of Aveiro Released: April
4 Project organisation and management in Portugal Participants Members of the steering committee of the project in Portugal Silvina Santana, PhD, University of Aveiro, coordinator of the Homecare project in Portugal, responsible for the effectiveness and economic evaluation José Rente, MD, Chief Neurologist of the Hospital Infante Dom Pedro Stroke Unit Conceição Neves, MSc, PhD candidate, University of Aveiro, Chief Nurse of the Hospital Infante Dom Pedro Stroke Unit Sandra Loureiro, PhD, University of Aveiro, consultant in data analysis Nina Szczygiel, MSc Economy, PhD candidate, University of Aveiro, network analysis Raquel Fonseca, PhD, University of Aveiro, consultant in economics and financial aspects Patrícia Redondo, BA in Public Administration, MSc in Management, PhD candidate, joined the steering committee in January 2010 Consultants in the Danish procedure Torben Larsen, Chief Consultant, MSc Econ CAST/SDU, Birgitte Jepsen, OT, MR, OUH Ringe HOMECARE team of professionals providing care at home Marta Viana, Gerontologist, MSc in Management, HOMECARE case manager Mariana Ribeiro, Gerontologist, MSc in Management, HOMECARE case manager Joana Freitas, Ocupational therapist Margarida Cerveira, Psychologist, Post-graduation in Neuropsychology Francisco Martins, Physiotherapist, MSc Sílvia Pinto, Occupational therapist Liliana Cardoso, Physiotherapist 4
5 Integrated home care for patients with stroke in Portugal: impact on patient functionality Silvina Santana, IEETA/DEGEI, University of Aveiro, Portugal Introduction Cerebrovascular disorders are an important issue in public health policy and practice worldwide (Truelsen, Piechowski-Jozwiak et al. 2006; Neyer, Greenlund et al. 2007; Taqui and Kamal 2007). Stroke burden is projected to rise from around 38 million DALYs globally in 1990 to 61 million DALYs in 2020 (Mackay and Mensah 2004). Beside stroke high prevalence and incidence in most industrialized countries, namely in Europe (Truelsen, Piechowski-Jozwiak et al. 2006), the disease is a major cause of long-term disability and poor quality of life, having a substantial social, emotional and economic impact on the daily lives of those affected (Daniel, Wolfe et al. 2009). Portugal has the highest stroke incidence, prevalence and mortality in Western Europe (Correia, Silva et al. 2004; Truelsen, Piechowski-Jozwiak et al. 2006). Stroke is the principal cause of both handicap and death in the country (Eurostat 2009). A study conducted in the Northern Portugal (Correia, Silva et al. 2004), analysing all suspected first-ever-in-a-lifetime strokes occurring between October 1998 and September 2000 has found a crude annual incidence of 3.05 (95% CI, 2.65 to 3.44) and 2.69 per 1000 (95% CI, 2.44 to 2.93) for rural and urban populations, respectively; the corresponding rates adjusted to the European standard population were 2.02 (95% CI, 1.69 to 2.34) and 1.73 (95% CI, 1.53 to 1.92). As the population ages, the actual number of events will continue to increase zeroing the positive effects of new medication and diagnosis technology (Kleindorfer 2007) and severely contributing to the exhaustion of health and social care systems. To help deal with the problem, the Unidades de Acidentes Vasculares Cerebrais (Stroke Units - SU) were created in In 2006, the National Network of Integrated Care (RNCCI) was launched by decree law to reduce costly acute care hospital cases and length of stay by substituting less costly care closer to the community. The network is based on establishing protocols with existing institutions, designated according to the kind of services provided as convalescence unit, medium- 5
6 term and rehabilitation unit, long-term and maintenance unit, palliative care unit and day care and autonomy promotion unit. Stroke patients discharged from acute care hospitals are then confronted with a number of possibilities when it turns to rehabilitation. Home care is supposed to be one important element in this network, but the conclusions of successive reports show that there is a lot to be done in this particular field. The benefits of treating acute stroke in specialised stroke wards in collaboration with specialised inpatient rehabilitation have been well established (Indredavik, Bakke et al. 1991; Indredavik, Slordahl et al. 1997; Indredavik, Bakke et al. 1999). Rehabilitation at home might outperform rehabilitation in an institution in terms of one or more health outcomes, such as number of deaths or institutionalizations, length of stay in acute care, chances of living independently at home and functional outcome (Indredavik, Fjaertoft et al. 2000; Bautz-Holter, Sveen et al. 2002; Larsen, Olsen et al. 2006; Langhorne and Holmqvist 2007; Fjaertoft, Rohweder et al. 2011; Larsen, Jaarsma T et al. 2012), especially early home supported discharge (EHSD) performed by well organised, multidisciplinary teams and involving patients with less severe strokes (Early Supported Discharge Trialists). Recently, EHSD has been evaluated as a dominant intervention able to deliver better health outcomes at lower costs (Larsen, Olsen et al. 2006; Larsen, Jaarsma T et al. 2012), namelly when following stroke unit care (Saka, Serra et al. 2009). The purpose of this study is to report on the primary outcome of a home supported discharge procedure for stroke patients implemented in Portugal from October 2009 to July Hypothesis We hypothesize that, within the HOMECARE group, the percentage of patients with indication for inpatient rehabilitation by the 2 nd and the 6 th month is lower than in the UC group. Therefore, besides looking to mean values of FIM scale at the several assessment points and poor outcomes such as deaths by the 6 th month after stroke, we propose to analyse the distribution, specially the lower level of the scale. No standard recommendation regarding the value of total FIM under which a patient should be considered for inpatient rehabilitation could be found in the literature. Considering that a patient with 3 points in each variable of the FIM scale (moderate assistance, execute between 50% and 74% of the task) would attain a total score of 54, we considered a threshold value of 60. This threshold seems to be in line with the practice in the country, but we would need to perform further analysis with more secondary data to fully understand the implications of this decision. 6
7 Methods Participants One hundred and ninety patients admitted to the stroke unit of Hospital Infante D. Pedro (HIP) (District of Aveiro, Centre Region, Portugal), which now is part of CHBV Centro Hospitalar Baixo Vouga), that fulfilled the exclusion/inclusion criteria (Table 1) and have signed the informed consent were included in the study. The patients were randomised equally to either early home supported discharge service (HOMECARE group, the study group) or usual care (UC group, the control group). A summarized description of the two groups of participants is provided in Table 2. Table 1. Exclusion criteria applied to HOMECARE trial in Portugal Patient aged less than 25 or more than 85 years old Pregnancy FIM score > 100 Patient resides outside the District of Aveiro Psychological illness and dementia that influences on participation in the study Massive speech and language disturbances that influences on participation in the study Earlier acquired damages to central nervous system or illness in the motor apparatus that influences participation in the study Other severe co-morbidity which influences participation in the project Transfer to another ward for more than 5 days Table 2. Descriptive of those admitted to the trial, by group All HOMECARE group UC group N Age (years) Mean age Lowest age Highest age Number of women Number of men Intervention The intervention starts at the Stroke Unit of the HIP, where patients are recruited for the trial. The post-discharge model is very complex and diversified. Patients are being rehabilitated at home, at RNCCI rehabilitation units (hereinafter denominated as RU, these might be Convalescence, 7
8 Medium-Term or Long-Term units in the RNCCI terminology), residential homes and as outpatients in central and second line hospitals and clinics, among others. These might be public organizations, private non-profit or for-profit entities or public-private partnerships. Patients in the study group receive rehabilitation at home, after being discharged from the SU for those discharged directly home, or after being discharged from the rehabilitation unit, for those discharged to a RNCCI convalescence unit for further inpatient rehabilitation. Patients in the control group receive the usual care. All the patients start their rehabilitation sessions in the SU, according to the standard already followed there. Home based rehabilitation is carried out by the patient s multidisciplinary HOMECARE team, which is organized according to the needs of each particular patient and might include a physiotherapist, an occupational therapist and a psychologist. In the Aveiro study, due to the highly fragmented character of the Portuguese health and social care systems and the absence of an information system connecting all the intervening entities, the team always include a gerontologist designated as the case manager. The randomization is conducted within the first 72 hours, around the 2nd-3rd day after admission. By that time it is sometimes too soon to know if the patient will be discharged directly home or referred to a convalescence unit for further rehabilitation but the case manager is immediately assigned. The HOMECARE team intervention begins during the admission to the SU where the patient and the informal caregiver first meet the case manager. For the patients discharged directly to their homes it continues after discharge in order to assure a seamless transference from hospital to home in accordance with best-practice in rehabilitation. For patients discharged to a RNCCI unit for further inpatient rehabilitation, contact from HOMECARE team is retaken when the planning for discharge home starts. The HOMECARE team and the content and scheduling of its intervention are defined taking in consideration patient s needs and expectations. In both cases, the HOMECARE team works with the patient at home for maximum one month. Figure 1 resumes the temporal arrangement of the intervention in the case of the study group. 8
9 Figure 1 Temporal arrangement of the intervention. In the HOMECARE group, family or friends and helpers are involved, receiving information about the stroke, its consequences and how to deal with it and collaborating in the rehabilitation. The team offers information and training tailored to the patient and the situation. Rehabilitation is focused on activities valued by a particular patient and happens in her/his natural context, in order to facilitate transference of effort and adaptation to daily life. The content varies from meaningful exercises (e.g., in order to be able to paint the nails again ) and personal care to walking outside, shopping and trying out leisure activities. As strategies and skills are directly implemented into real life it is easy for the patient and the family members and other caregivers to be aware and recognize the competencies and ability of the patient and follow the progress. The HOMECARE team also helps the patients in the study group and their caregivers and/or families with finding help in the community, for example looking for a wheelchair or a special bed, or the possible help with house adaptation. After being discharged from the SU, patients in the UC group might be referred to a RNCCI inpatient rehabilitation unit or to their homes without prescription of further rehabilitation or with prescription of rehabilitation sessions at outpatient services, public or private, to which patients might commute every working day. The focus of the intervention in ambulatory rehabilitation is more focused on the training of deficits or components of function (impairment), and therefore it is probably more difficult for the patients as well as for their caregivers to understand how things done at the outpatient service can be transferred into real life. Accessibility to health professionals for the family is not as easy as for the HOMECARE group and fewer opportunities are available to ask questions and get direct answers along with the training. In the RNCCI units, the patient is offered a multidisciplinary service, including occupational therapy and psychology sessions, when available and families are prompted to participate. 9
10 The Ethics Committee of the HIP approved the study. Instruments Physical and cognitive disability was assessed with the Functional Independence Measure (FIM). The level of a patient's disability indicates the burden of caring for them and items are scored on the level of assistance required for an individual to perform activities of daily living. The scale includes 18 items, of which 13 address physical dimensions based on the Barthel Index and 5 address cognitive dimensions. Each item is scored from 1 to 7 based on level of independence, 1 meaning complete dependency and 7 meaning complete independency. The FIM physical sub-dimensions are: self-care, sphincters control, transfers/mobility, and locomotion; the FIM cognitive subdimensions are: communication, and social cognition. In this study, FIM has been administered at admission to and discharge from the SU, at discharge from the RU, and at the 2 nd month and the 6 th month from admission to the SU. Patient pathway and assessment Within 72 hours after admission, the patients fulfilling the admission criteria that have agreed to participate in the study and have signed the informed consent, were included in the study and randomised to the HOMECARE group or the UC group. The patients randomized to the HOMECARE group were evaluated at discharge from the SU, at discharge from the RU, after the HOMECARE intervention and at follow-up visits by the 2 nd, the 6 th, and the 12 th month after admission to the SU. The case manager visits the patient at the SU and a meeting is scheduled with the partner, relatives or others probable informal caregiver. If the individual is to be discharged directly home, an individual rehabilitation plan is established and the need for assistance in the home is clarified. This could be help in the home in the home training period or adjustment of aids and temporary modifications in the patient s home. The HOMECARE team would then provide information to the patient and relatives and help them find help in the community. If the individual is to be discharged to a RU, the first contact with the patient at the SU is mainly for introducing the study and the HOMECARE team, with further work being made when the patient is to be discharged from the RU to home. Approximately eight home based sessions after the first visit are planned per patient in the rehabilitation plan. The sessions should take place within one month after discharge. Follow-up visits were made in the patients home 2 and 6 months after admission. 10
11 The patients in the UC group were not offered any HOMECARE service at home, receiving the usual care only. Each patient randomized to the UC group was assigned a case manager with the objective to assure that it would be possible to track the patient during the year she/he would remain in the study. The case manager was introduced to the patient and her/his family in the stroke unit and afterward performed the follow up visits in order to collect the necessary data by the 2nd and 6th months. Data analysis Following the usual procedure, we have computed total FIM (mean, lowest value and highest value) at the SU admission and discharge, and at the 2 nd and the 6 th months, by group and the number of deaths by group. Afterwards we have computed the percentage of individuals with FIM less than or equal to 60 points, by group. Table 3 provides descriptive of the cases validated for data analysis, by group. Table 4 provides destination after discharge from the SU, mean length of stay at the SU and total FIM (mean, lowest value and highest value), by group. Table 5 provides the percentage of individuals with FIM less than or equal to 60 points, by group. All analyses were performed with PASW Statistics Results According to the procedure described in the Methods, 190 participants were included in the trial. From these, 39 were afterwards excluded for one of the following reasons: quit the study after being admitted and no data in available from them but those collected on the admission to the SU; impossible to contact the patient after living the SU; never came out of the system and where still institutionalized by the 6 month). As a result, 151 patients were finally validated for data analysis. The basic demographics of this group are described in Table 3. Table 3. Descriptive of cases validated for data analysis, by group All HOMECARE group UC group N Age Mean age (years) Lowest age Highest age Number of women Number of men
12 Table 4 reports the number of patients discharged to a RU after being treated at the SU by group, the number of deaths by group, the length of stay at the SU by group and the total FIM (mean, lowest value and highest value) by group. The values are very similar between the two groups, but we see that, by the 2 nd and the 6 th months, the dispersion of the FIM values is higher in the control group, with some of the individuals scoring very low in the FIM scale by the time of the follow-up assessments. Table 4. Destination after discharge from the SU, length of stay at the SU and total FIM, by group N=151 HOMECARE group UC group Sig. N=72 N=79 Number of patients discharged to a RU Deaths 2 1 Length of stay at the SU, mean (st.dev.) 9.8 (5.5) 9.9 (4.9).357 FIM at SU admission Mean total FIM, mean (st.dev.) 71.2 (20.9) 71.1 (18.9).067 Lowest total FIM Highest total FIM FIM at SU discharge Mean total FIM, mean (st.dev.) 89.8 (27.7) 90.4 (24.3).101 Lowest total FIM Highest total FIM FIM at the 2 nd month Mean total FIM, mean (st.dev.) (20.6) (24.4).444 Lowest total FIM Highest total FIM FIM at the 6 th month Mean total FIM, mean (st.dev.) (18.2) (25.5).122 Lowest total FIM Highest total FIM In fact, the analysis of the cases with total FIM equal or lower than 60 points shows that while there are more such cases in the HOMECARE group at the admission and the discharge from the stroke unit, being the difference statistically significant at the discharge (p=.049), by the 2 nd and the 6 th months the number of cases is significantly higher in the control group (p=0.001 and p=0.002, respectively). 12
13 Table 5. Percentage of individuals with FIM less than or equal to 60 points, by group N % of individuals Sig. FIM <=60 at SU admission HOMECARE group UC group FIM <=60 at SU discharge HOMECARE group UC group FIM <=60 at the 2 nd month HOMECARE group UC group FIM <=60 at the 6 th month HOMECARE group UC group Discussion and conclusion In this study we report on the primary outcome of a home supported discharge procedure for stroke patients implemented in Portugal from October 2009 to July 2012 in the context of HOMECARE project. The trial can be considered a complex intervention and in such cases the use of a single outcome measure might be problematic (Bagiella 2009). On the other hand, the use of death as poor outcome might also be questionable. In fact, all deaths in the Portuguese trial were due to unfortunate developments of co-morbidities already present by the time of the randomisation. Therefore, we have adopted a different procedure, by looking into the FIM distributions at the several assessment points and computing the number of patients with FIM below a threshold value of 60 points. We assume that such patients would have indication for inpatient rehabilitation, even if knowing that improvement in their condition due to treatment offered by the 2 nd and the 6 th month after stroke would be very difficult. Results show that, while there are no differences in the average scores of FIM measured at the four assessment points between the HOMECARE and the UC groups, a result in line with other studies (Mayo and Scott 2011), the number of individuals with a FIM score equal or lower than 60 points at the 2 nd and the 6 th months is significantly higher in the UC group, which seems to support the efficacy of the HOMECARE intervention. This result is in line with the perception of the case managers that followed the participants from admission to the SU to 1 year after stroke. 13
14 References Bagiella, E. (2009). "Clinical trials in rehabilitation: single or multiple outcomes?" Arch Phys Med Rehabil 90(11 Suppl): S Bautz-Holter, E., U. Sveen, et al. (2002). "Early supported discharge of patients with acute stroke: a randomized controlled trial." Disabil Rehabil 24(7): Correia, M., M. R. Silva, et al. (2004). "Prospective community-based study of stroke in Northern Portugal: incidence and case fatality in rural and urban populations." Stroke 35(9): Daniel, K., C. D. Wolfe, et al. (2009). "What are the social consequences of stroke for workingaged adults? A systematic review." Stroke 40(6): e Early Supported Discharge Trialists "Services for reducing duration of hospital care for acute stroke patients." Cochrane Database of Systematic Reviews 2005(Issue 2. Art. No.: CD DOI: / CD pub2). Eurostat (2009). Health Statistics - Atlas on mortality in the European Union. Theme: Population and social conditions. Luxemburg, Office for Official Publications of the European Communities. Fjaertoft, H., G. Rohweder, et al. (2011). "Stroke unit care combined with early supported discharge improves 5-year outcome: a randomized controlled trial." Stroke 42(6): Indredavik, B., F. Bakke, et al. (1999). "Stroke unit treatment. 10-year follow-up." Stroke 30(8): Indredavik, B., F. Bakke, et al. (1991). "Benefit of a stroke unit: a randomized controlled trial." Stroke 22(8): Indredavik, B., H. Fjaertoft, et al. (2000). "Benefit of an extended stroke unit service with early supported discharge: A randomized, controlled trial." Stroke 31(12): Indredavik, B., S. A. Slordahl, et al. (1997). "Stroke unit treatment. Long-term effects." Stroke 28(10): Kleindorfer, D. (2007). "The bad news: stroke incidence is stable." Lancet Neurol 6(6): Langhorne, P. and L. W. Holmqvist (2007). "Early supported discharge after stroke." J Rehabil Med 39(2): Larsen, T., Jaarsma T, et al. (2012). Integrated Homecare in Europe for frail elderly somatic patients focusing on stroke, heart failure and COPD. A Health Technology Assessment. Larsen, T., T. S. Olsen, et al. (2006). "Early home-supported discharge of stroke patients: a health technology assessment." Int J Technol Assess Health Care 22(3): Mackay, J. and G. Mensah (2004). Atlas of Heart Disease and Stroke. Geneva, World Health Organization. Mayo, N. E. and S. Scott (2011). "Evaluating a complex intervention with a single outcome may not be a good idea: an example from a randomised trial of stroke case management." Age Ageing 40(6): Neyer, J., K. Greenlund, et al. (2007). Prevalence of Stroke United States, MMWR. 2007;56: CDC. Saka, O., V. Serra, et al. (2009). "Cost-effectiveness of stroke unit care followed by early supported discharge." Stroke 40(1): Taqui, A. and A. Kamal (2007). "Stroke in Asians." Pak J Neurol Sci 2(1): Truelsen, T., B. Piechowski-Jozwiak, et al. (2006). "Stroke incidence and prevalence in Europe: a review of available data." Eur J Neurol 13(6):
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