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.