RETAKE: RETurn to work After StroKE. Pragmatic, multicentre RCT with internal pilot, costeffectiveness evaluation and embedded process evaluation, comparing Early Stroke Specialist Vocational Rehabilitation (ESSVR) in addition to usual NHS Rehabilitation to usual NHS rehabilitation alone.
SETTING: 20 acute stroke units with stroke rehab services.
POPULATION: Acute stroke: INCLUSION: Age >18; in paid/unpaid work pre-stroke; provision of consent.
EXCLUSION: People not intending to work; living > one hour from the Hospital of hospital admission; no capacity to consent.
HEALTH TECHNOLOGY: Up to 12 months manualised ESSVR, delivered by trained OTs (2 per site), starting within 8 weeks of stroke. ESSVR: early (acute stroke) specialist (stroke & VR specialist knowledge) health-based (by HS staff) mixed VR (work return & job retention) community-based case management (CM).
CONTROL: Usual NHS rehabilitation provided by UC team. May involve outpatient/community physio-,speech- or OT therapy, psychology, medical follow-up.
RANDOMISATION: Individually randomised within 6wks of stroke, via CTU, stratified by site, age, severity.
DATA COLLECTION: Baseline face-to-face assessment; postal follow-up at 3, 6 & 12m, maximised with phone/text prompts & phone interviews.
PRIMARY OUTCOME: Return to work & job retention (self-report at 12 m).
SECONDARY OUTCOMES: Work related outcomes; Functional ability (Nottingham Extended Activities of Daily Living); Social participation (Community Integration Questionnaire); Mood (Hospital Anxiety and Depression Scale); Health Related Quality of Life (EQ-5D); Carer (Carer Strain Index); Intervention compliance; resource use; work self-efficacy (Work Ability Measure); and confidence (Confidence after Stroke Measure)
ECONOMIC EVALUATION: Within trial cost-effectiveness and cost-utility analyses (NHS & PSS perspective); wider perspective reported separately.
PROCESS EVALUATION: Explore ESSVR implementation (intervention fidelity, content, adherence & deployment) and contextual factors linked to outcome variation across intervention & UC. To include analysis of routine process indicators (treatment records, mentoring feedback in
ESSVR, resource use data from all participants) and focus groups & individual semi-structured interviews with stroke service users & NHS staff (manage, commission or deliver stroke rehabilitation)
SAMPLE SIZE: 760 (420 ESSVR; 340 control)