A stroke patient's return to work depends on whether they receive early, specialist vocational rehabilitation alongside standard NHS care. Around a quarter of strokes happen to people of working age, yet most NHS rehabilitation focuses on physical recovery rather than helping patients navigate the practical, psychological and employer-related barriers to getting back to a job. The RETAKE trial tests whether a package of roughly ten sessions of early, specialist vocational case management—delivered by trained occupational therapists within eight weeks of stroke—improves the proportion of patients who return to work and stay employed at 12 months. The trial will recruit 760 patients across 20 acute stroke units, comparing the intervention against usual care alone. If it works, the approach could shift how the NHS defines recovery after stroke: from purely clinical outcomes to include work as a measurable health goal. That would affect not just individual patients and their families, but also employers, the benefits system, and the wider economy, by reducing the long-term loss of skilled workers to stroke-related disability.
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DESIGN: Pragmatic multicentre RCT of ESSVR plus usual NHS Rehabilitation (UC) to UC alone with internal pilot & process evaluation SETTING: 20 acute stroke units with stroke rehab services POPULATION: Acute stroke INCLUSION: Age >18; in paid/unpaid work pre-stroke EXCLUSION: Not aiming to work, do not live in catchment area HEALTH TECHNOLOGY: ~10 sessions 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). ESSVR is supported by feasibility trial (2), policy (10-15) recognising ‘work’ as health outcome, professional recommendations (12) and evidence supporting early intervention, employer engagement and CM (31,32) Contamination minimised: UC group treated by different OTs, ESSVR OTs educated on contamination/told no discussing ESSVR with clinical teams CONTROL: Usual NHS rehabilitation provided by UC team. May involve outpatient/community physio-, speech- or OT therapy, psychology, medical follow-up. Few patients get VR in usual rehabilitation so easy to ensure UC don’t get VR (18,27,54) 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) validated in a 10% subsample SECONDARY OUTCOMES: Mood (Hospital Anxiety & Depression Scale)[37], function (Nottingham Extended Activities of Daily Living [38]), participation (Community Integration Questionnaire [39]), health-related quality of life (EQ-5D [40,41), confidence [42], intervention compliance, health/social care resource use & mortality. ECONOMIC EVALUATION: Within trial cost-effectiveness and cost-utility analyses (NHS & PSS perspective); wider perspective reported separately PROCESS EVALUATION [38]: Explore ESSVR implementation (intervention fidelity [76], content [77], 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) gives 90% power (5% alpha) to detect 13% difference [31] in job retention at 12m; assuming 26% control rate , 25% loss to follow-up, clustering in intervention only (cluster=11 , ICC=0.03, inflation factor=1.22) INTERNAL PILOT: In 8 sites; progression criteria recruitment assessed at 6m: green= = 2 pts/mth/site; amber=<2 but =1 pts/mth/site; red=<1pts/mth/site; follow-up assessed at 6m: green==80%; amber=<80% but =65%; red=<65% RECRUITMENT: 760 participants in 26m; 2 per site per mth. Consistent with other multicentre stroke rehab RCTs (50); feasible for intervention delivery at site TIMETABLE: 53m: 9m set-up; 26m recruitment; 12m follow up; 6m analysis, write-up, dissemination TEAM EXPERTISE: VR, stroke rehab, OT, rehabilitation medicine, clinical trials, health economics, statistics, implementation science, process analysis, occupational health
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