Title: RETurn to work After stroKE (RETAKE)
Funder: Department of Health and Social Care

Abstract: 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

Lay abstract: Aim: To evaluate the success of therapy to help people return to work (RTW) after stroke. Background: Return to work is a major goal for many stroke survivors but achieved by fewer than half of working people. There is a lack of evidence on how best to support stroke survivors wanting to RTW. A new therapy has been developed ‘Early Stroke Specific Vocational Rehabilitation’ (ESSVR). This is delivered by Occupational Therapists and includes matching survivors’ abilities to job demands and negotiating return to work with an existing employer. In a preliminary (feasibility) study, 46 stroke survivors from one hospital consented to be randomly allocated to ESSVR plus usual care, or usual care alone. Forty-one people declined. Most participants were men (36/46), average age 56 (range 18-78 years), had mild/moderate strokes and were in professional roles (65%) or self-employed at the time of stroke. Participants were followed up by postal questionnaire, including measures of productivity, mood, social participation and quality of life at 3, 6 and 12 months. This included questions about the financial impact of stroke and time lost from work. Some stroke survivors and employers were interviewed about ESSVRs acceptability and usefulness. Only one person withdrew from the intervention; 32 people (70%) were available at 12-month follow-up. Twice as many ESSVR participants were in work at 12 months, suggesting ESSVR may be better than usual care at returning stroke survivors to work. People who RTW appeared less depressed suggesting potential health benefits. Cost differences favoured ESSVR. People who received the support found it beneficial and employers valued the therapists’ stroke knowledge and communication from the NHS. Findings indicate ESSVR can be delivered, is acceptable and that its effect on work, health outcomes and costs can be measured. However, the study was too small to test whether the observed difference between ESSVR and usual care was due to the therapy or other factors. It was also only tested in one area with one Occupational Therapist. Design and methods: We propose to carry out a definitive national trial to test the clinical effectiveness of ESSVR and usual care (compared to usual care alone) at returning stroke survivors to work and keeping them there 12 months after stroke. We will include an economic evaluation (to test for cost effectiveness) and a process evaluation (to examine what was actually delivered during the trial and to elicit stroke survivors and staff’s views). Our multicentre randomised controlled trial will recruit 760 stroke survivors from 20 NHS centres. Approximately half will be randomly allocated to ESSVR and usual care, and half to usual care alone. We will follow up participants with postal questionnaires at three, six and 12 months and offer telephone interviews when needed. We have built in time points in the first year to check that we are recruiting to target across multiple sites and are collecting the expected number of questionnaires. Patient and public involvement: We worked with stroke survivors and employers to develop ESSVR and two stroke survivors will assist in protocol development, preparing patient facing materials, dissemination and trial governance.

Research activity codes: 6.7 PHYSICAL
Health categories: STROKE