Stroke Patients' Outpatient Rehabilitation Therapy (SPORT)
Condition: Stroke; Incentives; Stroke Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Background: Stroke is the leading cause of long-term disability in Singapore, and studies
      have found that intensive specialized stroke rehabilitation can improve post-stroke
      functional outcomes for a substantial proportion of stroke patients. However, despite the
      benefits associated with adherence to prescribed rehabilitation, the uptake rate of
      outpatient rehabilitation services (ORS) in Singapore is only 33%.

      According to local longitudinal studies, the financial burden of out-of-pocket service costs
      and the inconvenient transportation from home to rehabilitation centres are important
      barriers to access to ORS.

      Objective: To examine the effect and cost-effectiveness of providing incentives for ORS to
      improve the uptake of ORS compared to usual care (control) with no incentives

      Hypothesis: An evidence-based program to test the effectiveness of providing incentives to
      alleviate the financial burden as well as inconvenience of transportation for ORS will
      improve the uptake of and adherence to ORS among stroke patients.

      Methodology: This study is an individual-based randomized controlled trial (RCT) of 300
      stroke patients recruited from Singapore General Hospital (SGH) and Changi General Hospital
      (CGH). They will be randomized to one of three study arms (education only, free
      transportation, and free services and transportation) and interviewed at the time of
      recruitment and four months after the enrolment in the study. Participants' health
      conditions, socioeconomic situation, health & medical services utilization, stroke-related
      disability measures, quality of life, and reasons for uptake/rejection/withdraw from the
      services will be collected during both baseline and the 4th month assessments.

      Significance: As the first study in Singapore to test innovative ways to increase the stroke
      ORS uptake rates, it will provide evidence for future policy changes in financing outpatient
      rehabilitation and other long-term care services in Singapore. It will also provide important
      empirical parameter estimates for Systems Dynamics modelling of the demand and supply of ORS
      in Singapore.
    

Detailed description: 
      Background Stroke is the leading cause of long-term disability in Singapore. Stroke accounts
      for 9.1% of years of life lost (YLL) and 6.1% of disability-adjusted life years (DALYs). With
      a rapidly aging population, the burden of stroke is anticipated to grow correspondingly in
      the years to come. Stroke survivors with moderate or severe functional disabilities require
      long-term medical and social care, imposing financial and psychological burdens on the
      patients and their family members. Research indicates that intensive specialized stroke
      rehabilitation can improve post-stroke functional outcomes for a substantial portion of
      stroke patients. Extant studies also indicate that rehabilitation is cost-effective in both
      inpatient and outpatient settings, and can potentially lead to reductions in both sub-acute
      and long-term post-stroke healthcare costs. In addition, a longitudinal study on post-stroke
      patients in Singapore found that receiving outpatient rehabilitation service at day
      rehabilitation centers resulted in earlier functional recovery. However, despite the benefits
      associated with adherence to prescribed rehabilitation sessions, the uptake rate of and
      adherence to outpatient rehabilitation service in Singapore is low. Only 33% of stroke
      survivors who were recommended for post-discharge community-based rehabilitation actually
      took up the service. The low uptake rate also implies substantial potential avoidable
      disability among stroke patients in Singapore.

      Significance According to a longitudinal survey on patients who were discharged from
      community hospital and recommended for post-discharge outpatient rehabilitation in Singapore,
      financial burden of rehabilitation services and the inconveniences of transportation are
      associated with the low attendance rates to outpatient rehabilitation.

      Behavioral economic theory and empirical studies also suggest that the low rate of uptake and
      adherence, at least in part, is attributable to stroke patients' perceptions or uncertainty
      about the health benefits of rehabilitation. Stroke patients may make a decision to utilize
      ORS or not, based on incomplete information about the service attributes (e.g. service
      quality, social connectedness, and perceived benefits). Over time, patients and caregivers
      may update their perceived service attributes through information and education on stroke
      management or actual experiences. Hence, providing incentives to take up ORS and educational
      materials on post-stroke management will elevate the current uptake rate of ORS and long-term
      adherence.

      The proposed study will be the first attempt in Singapore to test innovative ways of
      encouraging uptake of stroke ORS. It will systematically test promising economic strategies
      that might be effective and cost-effective in increasing the uptake of and adherence to the
      prescribed ORS. Given the high bed occupancy rate in public acute hospitals in Singapore,
      outpatient center-based rehabilitation service could be a more viable option than inpatient
      rehabilitation and more cost-effective in Singapore. It will provide evidence for future
      policy change in financing outpatient rehabilitation service and other long-term care
      services in Singapore and other countries experiencing similar problems.

      Specific Aims & Hypothesis Stroke is the leading cause of long-term disability in Singapore,
      and the burden of stroke is posing challenges to the healthcare system and society. Previous
      international and regional research studies suggest that a substantial proportion of stroke
      patients can benefit from post-stroke rehabilitation services and achieve improved functional
      outcomes. However, despite government subsidies and Medisave coverage for outpatient
      rehabilitation, the uptake rate of outpatient rehabilitation service (ORS) among stroke
      patients is low.

      The investigators propose a randomized controlled trial (RCT) to test different interventions
      aimed at improving the uptake of and adherence to outpatient rehabilitation services: a
      rehabilitation educational program (Group 1, Education), free transportation only (Group 2,
      Transportation Incentives) and free transportation and rehabilitation sessions (Group 3,
      Transport & Sessions Incentives) for the first 3 months from the date of discharge.

      The study aims to:

        1. Examine whether incentives for outpatient rehabilitation services (Group 2 and Group 3)
           are more effective at improving the uptake of rehabilitation services compared with
           education program only (Group 1);

        2. Determine whether stroke patients in Group 3 Transport & Sessions Incentives are more
           likely to take up ORS than those in the Group 2 Transport Incentives only;

        3. Assess the effectiveness of interventions (Group 2 and Group 3) on patient health
           outcomes; and

        4. Evaluate the cost-effectiveness of the interventions (Group 2 and Group 3) at the 4th
           month.

      At each recruitment site, the Research Coordinator will assess the patient's eligibility
      before approaching them for recruitment. The patient will be given an Abbreviated Mental Test
      (AMT) for cognitive assessment. If the patient is cognitively unfit, then his/her
      caregiver/proxy will be required to sign the informed consent form on behalf of the patient.
      The enrolment period will last for approximately 14-16 months or when the recruitment target
      of 300 participants has been achieved.

      Baseline Assessment: After signing the informed consent form, the Research Coordinator will
      proceed with the baseline assessment which consists of participant's socioeconomic
      characteristics, health status, health and medical services utilization, financial status,
      stroke-related disability measures, quality of life, and self-efficacy.

      The Research Coordinator will educate all participants on their conditions and how to recover
      after stroke. A pamphlet with information on post-stroke rehabilitation will also be
      distributed to all participants.

      Patient-level Intervention: The intervention phase is for a period of three months
      post-discharge. The Study Team at Duke-NUS will be coordinating all the incentivised services
      for the participants

      Measures and Analysis The primary study outcome is uptake of outpatient rehabilitation
      services. Uptake is defined as a patient attending at least one rehabilitation session after
      discharge. A key secondary outcome will be adherence, defined as the proportion of times the
      participant attended prescribed outpatient rehabilitation sessions during the study period.
      Additional secondary outcomes of the study include measures of participants' stroke-related
      functional status (Modified Rankin Scale, mRS, and modified Barthel Index for Activities of
      Daily Living (ADL) limitation), quality of life (EQ-5D), resilience (CD-RISC 10), and
      participants' inpatient and other medical services utilization. The investigators will also
      obtain participants' baseline socio-demographic data and health status from electronic
      medical records and self-reported questionnaire as control variables. In addition, the
      program costs of all incentives provided to those in the interventions arms will be tracked
      systematically.

      The investigators will conduct bivariate analyses and employ generalized linear model to
      examine the differences among three study arms in the outcomes of interest, as identified
      above. For all the health outcome variables such as, functional status, and will employ a
      difference-in-differences (DID) design to assess the impact of incentives. This method
      controls for secular trends in outcomes by comparing the longitudinal change in the controls
      from the concurrent change in cases between the baseline and follow-up period. Specifically,
      the covariates for the interaction term in the regression model (i.e. the
      difference-in-differences estimates) represent the difference in the changes over time. In
      addition, the incremental cost-effectiveness ratios (ICER) for interventions will be
      calculated by dividing the difference in costs of control arm and that of intervention arms
      by the incremental effectiveness of both intervention arms compared with control arm.

      Power calculation Assuming the uptake rate for control arm is 33% and the detectable
      difference for the intervention arm is 10% (that is, the intervention arm that is most
      different from control has an uptake rate of 43%), the desired sample size is a total of 300
      subjects (100 per arm) to achieve 80% power and to accommodate 10% attrition.
    

Intervention name(s): Transportation incentives; Transportation and rehabilitation services incentives
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Free transportation only for the first 3 months post-discharge.; Free transportation and rehabilitation services 3 months post-discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research