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.

Background: Despite growing numbers of studies reporting the efficacy of complex interventions and their implementation, many studies fail to report information on implementation fidelity or describe how fidelity measures used within the study were developed. This study aimed to develop a fidelity checklist for measuring the implementation fidelity of an early, stroke-specialist vocational rehabilitation intervention (ESSVR) in the RETAKE trial. Methods: To develop the fidelity measure, previous checklists were reviewed to inform the assessment structure, and core intervention components were extracted from intervention descriptions into a checklist, which was ratified by eight experts in fidelity measurement and complex interventions. Guidance notes were generated to assist with checklist completion. To test the measure, two researchers independently applied the checklist to fifteen stroke survivor intervention case notes using retrospective observational case review. The scoring was assessed for interrater reliability. Results: A fidelity checklist containing 21 core components and 6 desirable components across 4 stages of intervention delivery was developed with corresponding guidance notes. Interrater reliability of each checklist item ranged from moderate to perfect (Cohen’s kappa 0.69–1). Conclusions: The resulting checklist to assess implementation fidelity is fit for assessing the delivery of vocational rehabilitation for stroke survivors using retrospective observational case review. The checklist proved its utility as a measure of fidelity and may be used to inform the design of future implementation strategies. Trial registration: ISRCTN, ISRCTN12464275. Registered on 13 March 2018.

Understanding what attributes or characteristics of those delivering interventions affect intervention fidelity and patient outcomes is important for contextualising intervention effectiveness. It may also inform implementation of interventions in future research and clinical practice. This study aimed to explore the relationships between attributes of Occupational Therapists (OTs), their faithful delivery of an early stroke specialist vocational rehabilitation intervention (ESSVR), and stroke survivor return-to-work (RTW) outcomes. Thirty-nine OTs were surveyed about their experience and knowledge of stroke and vocational rehabilitation and were trained to deliver ESSVR. ESSVR was delivered across 16 sites in England and Wales between February 2018 and November 2021. OTs received monthly mentoring to support ESSVR delivery. The amount of mentoring each OT received was recorded in OT mentoring records. Fidelity was assessed using an intervention component checklist completed using retrospective case review of one randomly selected participant per OT. Linear and logistic regression analyses explored relationships between OT attributes, fidelity, and stroke survivor RTW outcome. Fidelity scores ranged from 30.8 to 100% (Mean: 78.8%, SD: 19.2%). Only OT engagement in mentoring was significantly associated with fidelity (b = 0.29, 95% CI = 0.05–0.53, p < 0.05). Increased fidelity (OR = 1.06, 95% CI = 1.01–1.1, p = 0.01) and increasing years of stroke rehabilitation experience (OR = 1.17, 95% CI = 1.02–1.35) was significantly associated with positive stroke survivor RTW outcomes. Findings of this study suggest that mentoring OTs may increase fidelity of delivery of ESSVR, which may also be associated with positive stroke survivor return-to-work outcomes. The results also suggest that OTs with more experience of stroke rehabilitation may be able to support stroke survivors to RTW more effectively. Upskilling OTs to deliver complex interventions, such as ESSVR, in clinical trials may require mentoring support in addition to training to ensure fidelity.

Background: Returning to work after stroke has physical, psychological and financial benefits for stroke survivors. However, global evidence estimates return-to-work rates 1 year post stroke at < 50%. Although its importance is acknowledged by policy-makers and healthcare providers, vocational rehabilitation is not always part of National Health Service usual care post stroke. Currently, there is limited evidence of the effectiveness of return-to-work support interventions. RETurn to work After stroKE was a multicentre individually randomised controlled pragmatic trial, with embedded process and health economic evaluations. RETurn to work After stroKE aimed to establish whether Early Stroke Specialist Vocational Rehabilitation plus usual care improves the likelihood of return to work at 12 months post stroke compared to usual care alone. As part of an embedded process evaluation, longitudinal case studies enabled exploration of participants’ experiences of support to return to work in the trial. Objectives: This article aims to understand participants’ experiences of being supported to return to work and explores the social and structural factors which support, or act as barriers to, implementation of the Early Stroke Specialist Vocational Rehabilitation intervention. Method: A longitudinal case-study approach was used to compare experiences of post-stroke return-to-work support received over 12 months by 15 participants who received the Early Stroke Specialist Vocational Rehabilitation intervention plus usual care, and 11 participants who received usual care only. Data were gathered at three time points using follow-up questionnaires, health records, intervention delivery records and semistructured interviews with participants and seven nominated informal carers. Interviews were also conducted with 1 employer and 11 occupational therapists delivering the intervention. Setting: Sixteen National Health Service sites across England and Wales. Findings: In the intervention arm, stroke survivors, carers and employers reported benefits from information and support from the treating occupational therapist to facilitate acceptance of, and adaptation to, post-stroke abilities. Participants also valued occupational therapists’ provision of sustained and tailored vocational rehabilitation, co-ordinating their care and advocating for them in return-to-work discussions with their employers. Those unable to return to their previous employment were supported to consider alternative options. In contrast, participants who received usual care only reported feeling abandoned when community rehabilitation support ended, typically after 2–8 weeks. Usual care largely focused on restoring physical function, leaving these participants struggling to find return-to-work information, advice and support. Longitudinal case studies enabled psychosocial and environmental factors impacting on participants’ return-to-work experiences to be considered. Limitations: Recruitment to the process evaluation was impacted by the COVID-19 pandemic. It proved difficult to recruit employers for interview, and fewer women participated in the case studies (21 men, 5 women). Direct observation of intervention delivery could not be carried out as planned due to pandemic restrictions on access to clinical areas. Conclusions: These case studies highlighted self-reported differences between recipients of the Early Stroke Specialist Vocational Rehabilitation intervention plus usual care and participants allocated to usual care only. Aspects perceived as important in underpinning the differences in support included the length of Early Stroke Specialist Vocational Rehabilitation intervention, occupational therapist advocacy, employer liaison and ongoing workplace monitoring. Provision of these core components as part of post-stroke services may support and help to sustain return to work, with associated benefits for stroke survivors and wider society. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/130/11.

Objective: This paper describes the development of an Early Stroke Specialist Vocational Rehabilitation intervention to support return to work following stroke and its delivery in the RETAKE trial. Methods: Iterative three stage, target population approach to intervention development and evaluation informed by the Medical Research Council Framework. Stage 1 (Initial codevelopment): interviews with key stakeholder service providers and users’ and mapping of services supporting return to work after stroke to identify and explore barriers to and unmet needs for support; intervention codevelopment with experts and patient and public involvement (PPI). Stage 2 (Refinement): expert panel codevelopment workshops and systematic review to identify vocational rehabilitation intervention mechanisms of change in supporting return to work after stroke. Stage 3 (Testing): intervention piloting in two case studies, feasibility testing in a randomised controlled trial, acceptability interviews with stroke and employer participants. Further intervention refinement following delivery in the RETAKE randomised controlled trial. 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. Return to work issues reported by stroke survivors informed Early Stroke Specialist Vocational Rehabilitation prototype design objectives. Iterative developments following piloting included fatigue management, involvement of general practitioners, work simulation and liaison with other healthcare services. Interviews with 12 recipient stroke survivors and 6 employers identified additional features including occupational therapist 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, for example, peer support, supported self-management. Intervention mechanisms identified across the three 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, colocation, case co-ordination, Multidisciplinary Team (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, Early Stroke Specialist Vocational Rehabilitation was successfully delivered to 95.4% of allocated participants with 75.3% compliance. Intervention commenced a median 38 days (interquartile range 23–56, range 6–216) post stroke and continued for ≤ 12 months. Participants had a median seven intervention sessions (interquartile range 4–12, range 0–37), with discharge a median 10.3 months (interquartile range 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 (standard deviation 7.46, range 0–39)] and attended [mean 9.0 (standard deviation 7.16), range 0–37]. However, occupational therapist contact with employers only occurred for 109 (36.8%) participants and employer visits occurred for 74 (25.0%). The Early Stroke Specialist Vocational Rehabilitation focus changed between the feasibility and definitive trial, with greater emphasis on current issues, fatigue management and informal psychological support, possibly due to the coronavirus disease discovered in 2019 pandemic. A programme theory and logic model illustrating the refined intervention and a description of Early Stroke Specialist Vocational Rehabilitation delivered in the RETAKE trial is reported. Conclusion: This comprehensive description of Early Stroke Specialist Vocational Rehabilitation will enable occupational therapists to implement Early Stroke Specialist Vocational Rehabilitation in practice and facilitative future evaluation. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/130/11.

Background: Despite growing numbers of studies reporting the efficacy of complex interventions and their implementation, many studies fail to report information on implementation fidelity or describe how fidelity measures used within the study were developed. This study aimed to develop a fidelity checklist for measuring implementation fidelity of an early, stroke-specialist vocational rehabilitation intervention (ESSVR) in the RETAKE trial.Methods: To develop the fidelity measure, previous checklists were reviewed to inform assessment structure, core intervention components were extracted from intervention descriptions into a checklist, which was ratified by eight experts in fidelity measurement and complex interventions. Guidance notes were generated to assist checklist completion. To test the measure, two researchers independently applied the checklist to fifteen stroke survivor intervention case notes using retrospective observational case review. The scoring was assessed for interrater reliability.Results: A fidelity checklist containing 21 core components and 6 desirable components across 4 stages of intervention delivery was developed with corresponding guidance notes. Interrater reliability of each checklist item ranged from moderate to perfect (Cohen’s kappa 0.69-1).Conclusions: The resulting checklist to assess implementation fidelity is fit for assessing delivery of vocational rehabilitation for stroke survivors using retrospective observational case review. The checklist proved its utility as a measure of fidelity and may be used to inform the design of future implementation strategies.Trial Registration: ISRCTN, ISRCTN12464275. Registered on 13th March 2018.