Development and description of Early Stroke Specialist Vocational Rehabilitation (ESSVR) delivered in the Return to work after stroke (RETAKE) Trial

Objective This paper describes the development of an Early Stroke Specialist Vocational Rehabilitation (ESSVR) intervention to support return to work (RTW) following stroke and its delivery in the RETAKE Trial. Methods Iterative three stage, target population approach to intervention development and evaluation informed by the MRC Framework. Stage 1 (Initial co-development) Interviews with key stakeholder service providers and users’ and mapping of services supporting RTW after stroke to identify and explore barriers to and unmet needs for support; intervention co-development with experts and PPI. Stage 2 (Refinement): Expert panel co-development workshops and systematic review to identify VR intervention mechanisms of change in supporting RTW after stroke. Stage 3 (Testing): intervention piloting in two case studies, feasibility testing in a randomised controlled trial (RCT), acceptability interviews with stroke and employer participants. Further intervention refinement following delivery in the RETAKE RCT. Results Stage 1: Service mapping and 25 stakeholder interviews identified service gaps and unmet needs relating to early identification of employed stroke survivors, mild stroke, and hidden disabilities. Access to timely support relied on geographical proximity to a specialist hub and tacit knowledge of complex health, education and employment services and provider roles. RTW Issues reported by stroke survivors informed ESSVR prototype design objectives. Iterative developments following piloting included fatigue management, involvement of GPs, work simulation and liaison with other healthcare services. Interviews with 12 recipient stroke survivors and 6 employers, identified additional features including OT negotiation skills, ability to respond to changing needs over time and patient empowerment to self-re-refer. The review corroborated intervention components and mechanisms and identified additional mechanisms e.g. peer support, supported self-management. Intervention mechanisms identified across the 3 stages were early intervention, understanding the impact of stroke on the person, their job and work environment, vocational goal setting, implementing workplace accommodations, individual tailoring, work preparation, co-location, case coordination, MDT working, employer engagement and education, and responsiveness, which involved monitoring work stability, providing feedback, and responding to changing needs over time and participant self-re-referral. In RETAKE ESSVR was successfully delivered to 95.4% of allocated participants with 75.3%. compliance. Intervention commenced a median 38 days (IQR 23-56, range 6-216) post stroke and continued for ≤12 months. Participants had a median 7 intervention sessions (IQR 4-12, range 0-37), with discharge a median 10.3 months (IQR 5.5-12.0, range 0-15.4) post-randomisation. Most intervention sessions were delivered via telerehabilitation (51.7%), in participants’ homes (35.9%) or workplaces (6.4%). There was little difference between the number of sessions offered (mean 9.6 (SD 7.46, range 0-39) and attended (mean 9.0 (SD 7.16), Range 0-37). However, OT contact with employers only occurred for 109 (36.8%) participants and employer visits occurred for 74 (25.0%). The ESSVR focus changed between the feasibility and definitive trial, with greater emphasis on current issues, fatigue management and informal psychological support, possibly due to the Covid-19 pandemic. A programme theory and logic model illustrating the refined intervention and a description of ESSVR delivered in the RETAKE trial is reported. Conclusion This comprehensive description of ESSVR will enable OTs to implement ESSVR in practice and facilitative future evaluation. Funding The stakeholder interview, mapping study, co-development, piloting and feasibility trial were funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for Nottinghamshire, Derbyshire, Lincolnshire (NDL). The RETAKE Trial was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (15/130/11). Registration: ISRCTN12464275.