Effectiveness of early vocational rehabilitation versus usual care to support RETurn to work After stroKE: a pragmatic, parallel arm multi-centre, randomised-controlled trial

Background Return-to-work is a major goal achieved by fewer than 50% stroke survivors. Evidence on how to support return-to-work is lacking. Aims To evaluate the clinical effectiveness of Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) versus UC alone for helping people return-to-work after stroke. Methods This pragmatic, multicentre, individually randomised controlled trial with embedded economic and process evaluations, compared ESSVR with UC in 21 NHS stroke services across England and Wales. Eligible participants were aged ≥18 years, in work at stroke onset, hospitalised with new stroke and within 12-weeks of stroke. People not intending to return-to-work were excluded. Participants were randomised (5:4) to individually-tailored ESSVR delivered by stroke-specialist occupational-therapists for up to 12-months or usual National Health Service rehabilitation. Primary outcome was self-reported return-to-work for ≥2 hours per week at 12-months. Primary and safety analyses were done in the intention-to-treat population. Results Between 1st June-2018, and 7th March-2022, 583 participants (mean age 54.1 years [SD 11.0], 69% male) were randomised to ESSVR (n=324) or UC (n=259). Primary outcome data were available for 454(77.9%) participants. Intention-to-treat analysis showed no evidence of a difference in the proportion of participants returned-to-work at 12-months (165/257[64.2%] ESSVR vs 117/197[59.4%] UC; adjusted odds ratio 1.12 [95%CI 0.8 to 1.87],p=0.3582). There was some indication that older participants and those with more post-stroke impairment were more likely to benefit from ESSVR (interaction p=0.0239 and p=0.0959 respectively). Conclusions To our knowledge, this is the largest trial of a stroke VR intervention ever conducted. We found no evidence that ESSVR conferred any benefits over UC in improving return-to-work rates 12-months post-stroke. Return-to-work (for at least 2 hours per week) rates were higher than in previous studies (64.2% ESSVR versus 59.4% UC) at 12-months and more than double that observed in our feasibility trial (26%). Interpretation of findings was limited by a predominantly mild-moderate sample of participants and the Covid-19 pandemic. The pandemic impacted the trial, ESSVR and UC delivery, altering the work environment and employer behaviour. These changes influenced our primary outcome and the meaning of work in people’s lives; all pivotal to the context of ESSVR delivery and its mechanisms of action. Data access: Data available on reasonable request. Registration: ISRCTN12464275.