An extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT

BackgroundThere is limited evidence about the effectiveness of rehabilitation in meeting the longer-term needs of stroke patients and their carers.ObjectiveTo determine the clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS).DesignA 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.SettingNineteen NHS study centres.ParticipantsPatients with a new stroke who received early supported discharge and their informal carers.InterventionsFive 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 measuresThe 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.ResultsA 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 ...