Background: There is limited evidence about the effectiveness of rehabilitation in meeting the longer-term needs of stroke patients and their carers.
Objective: To determine the clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS).
Design: A pragmatic, observer-blind, parallel-group, multicentre randomised controlled trial with embedded health economic and process evaluations. Participants were randomised (1 : 1) to receive EXTRAS or usual care.
Setting: Nineteen NHS study centres.
Participants: Patients with a new stroke who received early supported discharge and their informal carers.
Interventions: Five EXTRAS reviews provided by an early supported discharge team member between 1 and 18 months post early supported discharge, usually over the telephone. Reviewers assessed rehabilitation needs, with goal-setting and action-planning. Control treatment was usual care post early supported discharge.
Main outcome measures: The primary outcome was performance in extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post randomisation. Secondary outcomes at 12 and 24 months included patient mood (Hospital Anxiety and Depression Scale), health status (Oxford Handicap Scale), experience of services and adverse events. For carers, secondary outcomes included carers' strain (Caregiver Strain Index) and experience of services. Cost-effectiveness was estimated using resource utilisation costs (adaptation of the Client Service Receipt Inventory) and quality-adjusted life-years.
Results: A total of 573 patients (EXTRAS, n = 285; usual care, n = 288) with 194 carers (EXTRAS, n = 103; usual care, n = 91) were randomised. Mean 24-month Nottingham Extended Activities of Daily Living Scale scores were 40.0 (standard deviation 18.1) for EXTRAS (n = 219) and 37.2 (standard deviation 18.5) for usual care (n = 231), giving an adjusted mean difference of 1.8 (95% confidence interval -0.7 to 4.2). The mean intervention group Hospital Anxiety and Depression Scale scores were not significantly different at 12 and 24 months. The intervention did not improve patient health status or carer strain. EXTRAS patients and carers reported greater satisfaction with some aspects of care. The mean cost of resource utilisation was lower in the intervention group: -£311 (95% confidence interval -£3292 to £2787), with a 68% chance of EXTRAS being cost-saving. EXTRAS was associated with 0.07 (95% confidence interval 0.01 to 0.12) additional quality-adjusted life-years. At current conventional thresholds of willingness to pay for a quality-adjusted life-year, there is a 90% chance that EXTRAS is cost-effective.
Conclusions: EXTRAS did not improve stroke survivors' performance in extended activities of daily living but did improve their overall satisfaction with services. Given the impact on costs and quality-adjusted life-years, there is a high chance that EXTRAS could be considered cost-effective.
Future work: Further research is required to identify whether or not community-based interventions can improve performance of extended activities of daily living, and to understand the improvements in health-related quality of life and costs seen by provision of intermittent longer-term specialist review.
Trial registration: Current Controlled Trials ISRCTN45203373.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 24. See the NIHR Journals Library website for further project information.
Keywords: COMMUNITY SERVICES; EARLY SUPPORTED DISCHARGE; HEALTH ECONOMIC EVALUATION; PROCESS EVALUATION; RANDOMISED CONTROLLED TRIAL; REHABILITATION; STROKE; TELEPHONE REVIEW.
Early supported discharge enables stroke patients with mild or moderate disability to be discharged earlier than usual from hospital to continue rehabilitation at home. Randomised controlled trials have demonstrated that early supported discharge leads to increased independence for stroke survivors, and that early supported discharge is cost-effective. Early supported discharge is usually provided for up to 6 weeks and patients with ongoing physical, psychological or social needs are then referred to other services. In the UK, provision of longer-term rehabilitation is often limited. Lack of research evidence has meant that service development in this aspect of stroke care has lagged behind service development for acute care. This clinical trial evaluated an extended stroke rehabilitation service (EXTRAS) that started when early supported discharge ended. Stroke survivors and their carers were randomly assigned to receive EXTRAS or usual NHS care. EXTRAS involved five rehabilitation reviews conducted over 18 months by an early supported discharge team member, usually over the telephone. Each review consisted of an assessment of current needs, goal-setting and action-planning, and sought to improve patients’ abilities and confidence to undertake extended activities of daily living (mobility, kitchen and domestic tasks, and leisure activities). There were no specific assessments or actions for carers but it was important to evaluate the impact that the new service had on carers. Patients and carers were followed up for 2 years and information was collected about their activities, mood, quality of life and services received. EXTRAS did not improve stroke survivors’ performance in extended activities of daily living. However, patients who received EXTRAS reported less anxiety and less depression than those who received usual care, and patients and carers were more satisfied with some aspects of their care. EXTRAS did not improve carers’ quality of life or stress. Health economic analyses suggest that EXTRAS improved patients’ quality of life and may be good value for money. Further research is needed to identify other treatments to address the longer-term consequences of stroke.