Post stroke care delivery is disorganised and fragmented even in the best of public health systems across the globe [1, 2]. Developing countries face greater challenges in providing optimal post stroke care when resources are prioritised to providing specialist care services, which may not be accessible to the majority. In general, patients receive treatment during acute phase at hospitals, and will be discharged after a 5–7-day stay [3, 4]. Patients and their caregivers will then have to fend for themselves, based on whatever facilities available in the community. Similarly, for those who did not have access to hospitals during the acute stroke period, will eventually seek out treatment from their primary care provider. As stroke care is multidisciplinary per se, organising care across different care environments becomes a challenge, particularly when healthcare resources are finite. To ensure equity in healthcare service provision in developing countries, where most specialist stroke care services are based in urban areas, shared care approaches with the primary healthcare services becomes a necessity.
In-patient rehabilitation facilities for post-stroke patients within the public healthcare system are few and mostly oversubscribed. Assisted living facilities, which are available in developed countries, are mostly non-existent in developing countries. Out-patient rehabilitation services are available in hospitals in urban and some sub-urban areas but often oversubscribed and unable to provide optimum neurorehabilitation services. The patients’ family and the primary care team in their area are the only sources of continuous support for post stroke patients in developing countries. Therefore, pooling resources and expertise to ensure equity in provision of quality post stroke care beyond geographical and health system-related shortcomings, may be the only solution for developing countries.
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In Malaysia, the primary care teams, led by trained Family Medicine Specialists (FMS), have been instrumental in providing post stroke care at public primary care healthcentres in the last two decades. However, the FMS’ faced challenges in coordinating the rehabilitation aspect for stroke survivors at the healthcentres, for those initiated by the tertiary care team or for stroke survivors who present late to the healthcentres [5]. The addition of rehabilitation services at public primary care healthcentres in the last 5 years (i.e. from 2011 to 2012 onwards) has reduced access-related difficulties to some extent. Public primary care healthcentres are now equipped with either Physiotherapy and/or Occupational Therapy services to provide general rehabilitation service for the community. The local clinical practice guidelines for management of stroke [6, 7] did not address the role of the primary care team in provision of longer-term stroke care (i.e. medical and rehabilitation aspects) for the majority of patients who were discharged home and residing in communities which lack access to Specialist Stroke care services.
The design of the trial was a pragmatic cluster randomised controlled trial-within trial at public primary care healthcentres. The trial was conducted between 1st July 2012 till 31st July 2013.
Considering the constraints in resources for this study, power of study was set at 80%, with the desired group difference in mean EQ-5D-5 L index scores estimated at a rate of 15%. A change in behavioral indicators in the order of 10–15% is recommended as the minimum for target group survey efforts, as attempts to measure changes of smaller magnitudes with adequate precision would exceed available resources [9]. Following this assumption, 65 patients were required on each arm. Due to the lack of studies on long-term outcomes of stroke patients residing at home in community, it was decided that studies which assessed quality of life on patients residing in the community at least 6 months post stroke, and utilised any outpatient facilities was used as guide to calculate sample size of subjects [10‐12].
A total of 151 patients were recruited during the trial period (July 2012–July 2013), where patients were monitored for duration of 6 months according to the assigned protocols. The primary outcome of the trial was quality of life of post stroke patients undergoing both programs, using the EuroQoL EQ-5D-5 L questionnaire.
Economic evaluation
The cost analysis was conducted from a societal perspective, i.e. where all possible costs and benefits to all sectors of society were estimated. In this study, this comprises the healthcare providers, stroke patients and caregivers.
Cost analysis
This was done following principals determined by Drummond et al. [13]. Provider costs were calculated by estimating capital costs (i.e. building, clinic equipment costing ≥RM500) and recurrent costs (i.e. administration, maintenance, utilities, Staff emolument and benefits, consumables and drugs) incurred to operate the healthcentre. Sources of data came from annual returns, administrative and financial records for year 2012. In all healthcentres, charges for the patients were waived if patients were Malaysians who were retired civil servants, from elderly age group (i.e. at or more than 60 years old) and if patients were registered with the Social Welfare Department as ‘Orang Kurang Upaya’ (OKU) or physically challenged persons.
Patient diaries provided primary data for patient out-of-pocket costs. This included money spent on transportation costs to and from the healthcentre, meals taken during trips, service or clinic registration charges other than at public healthcare facilities, miscellaneous expenditures incurred resulting from stroke complications (e.g. alternative and complementary treatments). Loss of productivity for patient and/ or their caregivers was included. Patients were asked to fill out the diaries during the clinic visits, and the average values were used.
For this study, the QALYs were calculated at baseline (recruitment) and exit visit at week 24. The differences in treatment outcomes (i.e. QALY) between the two programmes were calculated. This was done by multiplying the utility weights with the expected number of remaining life-years following the acute stroke period. The expected number of remaining life-years was obtained from life expectancy tables for stroke survivors generated by Hannerz and colleagues [18] as the morbidity and mortality of stroke survivors were not comparable to that in a normal population.
The incremental cost effectiveness ratio (ICER) was imputed by dividing the differences in cost of the alternative programmes with the differences between outcomes. Finally, a sensitivity analysis was performed to test if any changes in the parameters would change the ICER values and influence conclusions made from the CEA. The trial protocol is summarised in Fig. 1.
Approval to conduct the study was obtained from the Ethics Committee, Faculty of Medicine, Universiti Kebangsaan Malaysia (Research ID GUP-UKM-2011-321) as well as Ministry of Health, Malaysia (Research ID: NMRR-11-1074-10,358).
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Results
Sociodemographic and clinical characteristics of the post stroke patients
The overall mean age at stroke was 55.8(SD9.8) years. The sociodemographic characteristics of patients in both arms were not statistically different (please refer Table 2). Clinical changes of the patients after 24 weeks are summarized in Table 3.
Table 2
Socio-demographic characteristics of patients enrolled according to intervention groups (N = 151)
Functional status, modified Barthel Index (mBI) scores
Baseline
90 (75,100)
95 (75,100)
z = −0.430
0.667
Exit
82.1 (75,100)
95 (80,100)
z = −0.400
0.689
Depression screen, PHQ9 scores
Baseline
≥10
6 (9.2)
6 (7.0)
Fisher’s exact
0.793
< 10
59 (90.8)
80 (93.0)
Exit
≥10
1 (1.2)
6 (7.0)
Fisher’s exact
0.240
< 10
85 (98.8)
80 (93.0)
Quality of life, EQ-5D-5L scores
The overall median EQ-5D-5L utility score at baseline is 0.53 (0.40,0.73). Analysis between both groups using Mann Whitney tests showed that there were no significant differences in both EQ-5D-5L scores at baseline and at 6 months (p > 0.05). See Table 4.
Table 4
Changes in EQ-5D scores among post stroke patients in 24 weeks (N = 151)
aPrivate clinics and other charges related to treatment for stroke, also includes transport and food and beverage expenses during visit
Figures in bold are statistically signifcant
Cost components or cost drivers
In terms of distribution of providers’ costs by components, staff emolument (58.2%) was the highest, followed by drug costs (27.7%), maintenance (4.7%), consumables (3.7%), administration (3.3%), utilities (1.9%) and equipment (0.5%). For patient costs, other direct costs (e.g. costs for treatment from private clinics, charges related to treatment for stroke plus transportation costs, food and beverage expenses during the visits) were the major component (71.3%), followed by caregivers/ productivity loss (16.5%) and patients’ productivity loss (12.2%).
Cost per quality adjusted life-years (QALY) gained
In this study, the scenarios, were made on the assumption that the providers’ cost may be altered in situations such as the total number of visits (in 6 months) made to the healthcentres for post stroke care (i.e. for either consultation, laboratory investigations or for prescription refill or combination of reasons), lower ranking personnel were involved in the care provision or the healthcentres did not have facilities for rehabilitation.
The best-case scenario was assumed when post stroke management had resulted in the highest improvement in health status, as per achieved in QALY and clinical outcomes-especially functional status. Hence, the patient and/or the caregiver no longer feels that further rehabilitation (i.e. therapist-led sessions held at healthcentres) would be beneficial, or patients had attained the highest functional ability based on their stroke type and continued to exercise while in their own homes or both parties lack awareness on its benefits i.e. did not pursue rehabilitation therapy. However, these patients and/or their caregivers will continue to seek treatment for the stroke risk factors or co-morbid conditions from the healthcentres.
In our study, the patients mainly resided at home after discharge, bypassing long-term admission (institutionalisation) in community rehabilitation facilities or state-funded nursing homes usually described in literatures from developed countries. From the patients’ perspective, our study documented that the loss of productivity of caregivers’ was slightly more than the patients’ themselves (16.5% vs 12.2%). This finding provides objective evidence of economic consequences for the caregiver of stroke patients who reside at home in the community.
The sensitivity analysis conducted for this study was based on current public health care service provision in this country and catered towards the various types of primary care visits for long-terms care of stroke patients who are synonymous with patients requiring chronic care or treatment for non-communicable diseases.
Financial data was only available from three out of the 10 primary care public healthcentres. Some of the financial records of the healthcentres were not available on site, and were kept in the District Health Office in charge of several healthcentres within the region. Filing of financial records for each district was inhomogeneous and this made tracing the records difficult. The period taken to trace the financial records alone took 12 months in total, and caused unavoidable delays during the trial. Future studies should address estimation of national unit costs for care at public primary healthcare services according to various healthcentre subtypes to facilitate future economic evaluations.
We wish to record our profound gratitude to our hardworking team of co-investigators for their diligence and assistance during the trial: Dr. Baizury Basha, Dr. Mohd Faudzi Abdullah, Dr. Norhasimah Ismail, Dr. Yusmawati Yusof, Dr. Hamimah Saad, Dr. Nor Asiah Hashim, Dato’ Dr. Mohd Daud Che Yusof, Dr. Salmiah Mohd Shariff, Dr. Mohd Fairuz Ali, Dr. Zuraida Che’ Man, SRN Asriah Ishak and SRN Zazalina Muhamad.
Ms. Zahirrah Begum Mohd Rasheed for her invaluable assistance during the site visits and trial logistics arrangements. We would like to thank Director General of Health Malaysia for his permission to publish.
Ethics approval and consent to participate
The Research Ethics Committee of Universiti Kebangsaan Malaysia Medical Centre (Approval reference no: 1.5.3.5/244/UKM-GUP-2011-327), National Institutes of Health Malaysia, Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia approved this study as well as the informed consent procedure (in 2012). Informed written consent to participate in this study was obtained from all participants.
Consent for publication
Not applicable.
Competing interests
The authors declare they have no competing interests.
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