Effectiveness of early vocational rehabilitation versus usual care to support RETurn to work after stroKE: A pragmatic, parallel-arm multicenter, randomized controlled trial.

Abstract

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: This study aimed 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 randomized 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, hospitalized with new stroke and within 12 weeks of stroke. People not intending to return-to-work were excluded. Participants were randomized (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 h per week at 12 months. Primary and safety analyses were done in the intention-to-treat population.

Results: Between 1 June 2018, and 7 March 2022, 583 participants (M_age 54.1 years (SD 11.0), 69% male) were randomized 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: 0.75-1.68), p = 0.5678). 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).

Conclusion: To our knowledge, this is the largest trial of a stroke vocational rehabilitation (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 h per week) rates were higher than in previous studies (64.2% ESSVR vs 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 behavior. 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.