Early stroke specialist vocational rehabilitation for return to work after stroke: a synopsis from the RETAKE RCT

<b>Background: </b>Return-to-work (RTW) is achieved by &lt;50% stroke survivors. Evidence on support for RTW is lacking. <br/><br/><b>Objective:</b> To determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) is more clinically-and cost-effective at supporting RTW 12-months after stroke than usual care (UC).<br/><br/><b>Design and methods:</b> Pragmatic, observer-blind, multicentre superiority randomised controlled trial with embedded health economic evaluation. Participants were individually-randomised, 5:4, to receive Occupational Therapy (OT)-led ESSVR+UC or UC. Questionnaire follow-up at 3-, 6- and 12-months post-randomisation. Mixed-methods process evaluation explored intervention experience, fidelity, compliance and implementation. <br/><br/><b>Setting:</b> 21 NHS stroke services in England and Wales.<br/><br/><b>Participants:</b> Patients with new stroke within 12-weeks, aged ≥18, in paid/unpaid work at stroke onset. People not-intending to RTW excluded. <br/><br/><b>Intervention:</b> OTs assessed stroke impact on participants and their job; coordinated NHS/employer/other stakeholders’ support; negotiated job-accommodations, monitored RTW and explored alternatives if RTW unfeasible. UC involved NHS rehabilitation provided by community teams and medical follow-up.<br/><br/><b>Main outcome measures: </b>Primary outcome: self-reported RTW for ≥2 hours/week 12-months post-randomisation. Secondary outcomes; mood, functional ability, participation, productivity, work self-efficacy, health-related quality-of-life, confidence, mortality, carer-strain, cost-consequences, COVID-19 impact. <br/><br/><b>Results: </b>Between 1st June 2018 and 7th March 2022, 583 participants (mean age 54 years [SD 11.1], 69.0% male, mean 29.9 days [SD 20.0] post-stroke, 452 [82.8%] ischaemic stroke) were randomised to ESSVR (n=324) or UC (n=259). Primary and secondary outcome data were available for 454 (77.9%) and 316 (54.2%) participants respectively. Intention-to-treat analysis showed no statistically significant difference in RTW between groups 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). Similar proportions of adverse events occurred in both groups (40/241 [16.6%] attended A&amp;E, 24/244 [9.1%] hospital admissions, 6/266 [2.3%] work accidents at <br/>12-months). Exploratory subgroup analyses indicated ESSVR potentially benefits older people (60+), and those with two or more post-stroke impairments.<br/><br/>Health economic outcomes were consistent with primary clinical outcomes. Analysis using multiple imputation, adjusting for age, sex, utility or cost at baseline and site found ESSVR had higher costs (incremental cost £1,337 (95% CI -1,113 to 3,787) and slightly more favourable incremental QALYs of 0.019 (95% CI -0.012 to 0.051).<br/><br/>ESSVR was valued by participants and service managers. In contrast UC participants reported limited or no VR and poor communication. Intervention compliance was achieved for 244 (75.3%) participants. Mentor support for OTs appeared to increase fidelity. <br/><br/><b>Limitations:</b> Most participants had mild-moderate stroke, unlike our feasibility evaluation which informed the sample size (powered to detect an absolute 13% difference in RTW). More people RTW than anticipated. There was significant loss-to-follow-up for primary, secondary and health economic outcomes. Employers proved difficult to recruit and engage.<br/><br/><b>Conclusions: </b>RETAKE was unable to demonstrate an effect or cost-effect of ESSVR on RTW 12-months post-randomisation. The Covid-19 pandemic influenced employer behaviour, and remote working diluted ESSVR mechanisms in a predominantly mild-moderate sample, many of whom were able to self-navigate RTW. <br/><br/><b>Future work: </b>Research is needed to confirm ESSVR benefits in people marginalised by age or post-stroke impairment, and determine what interventions benefit younger stroke survivors.<br/>