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临床试验/NCT03165630
NCT03165630已完成不适用

A Randomized Controlled Trial to Improve the Uptake of and Adherence to Outpatient Rehabilitation Services Among Stroke Patients

National University of Singapore1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2017年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
266
试验地点
1
主要终点
Uptake rate of incentivised rehabilitation services

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The 4th month assessor is unaware of the arm participants are assigned to.

入排标准

年龄范围
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with stroke as defined by the World Health Organization's criteria;
  • Discharged to home;
  • Recommended by physicians to continue outpatient rehabilitation afte discharge;
  • Singapore citizen or Permanent Resident; and
  • Provision of informed consent.

排除标准

  • Stroke patients who are suffering from severe dysphasia without caregiver or proxy;
  • Cognitively impaired patients without caregiver or proxy; and
  • Age < 20 years.

结局指标

主要结局

Uptake rate of incentivised rehabilitation services

时间窗: 3 months post-discharge

Uptake rate of incentivised services will be measured by number of participants who attend at least one rehabilitation session.

次要结局

  • Adherence rate of incentivised rehabilitation services(3 months post-discharge)
  • Effectiveness of interventions on participants' health outcomes(Change from Baseline MBI at 4 months)
  • Cost effectiveness of incentivised ORS(3 months post-discharge)
  • Barriers for outpatient rehabilitation services (ORS) utilization(3 months post discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. David Matchar

Professor and Director, Health Services & Systems Research, Duke-NUS Medical School

National University of Singapore

研究点 (1)

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