Return to work is achieved by < 50% stroke survivors. Evidence on support for return to work is lacking. To determine whether Early Stroke Specialist Vocational Rehabilitation is more clinically effective and cost-effective at supporting return to work 12 months after stroke than usual care. Pragmatic, observer-blind, multicentre superiority randomised controlled trial with embedded health economic evaluation. Participants were individually randomised, 5 : 4, to receive occupational therapy-led Early Stroke Specialist Vocational Rehabilitation + usual care. Questionnaire follow-up at 3, 6 and 12 months post randomisation. Mixed-methods process evaluation explored intervention experience, fidelity, compliance and implementation. Twenty-one NHS stroke services in England and Wales. Patients with new stroke within 12 weeks, aged ≥ 18, in paid/unpaid work at stroke onset. People not intending to return to work excluded. Occupational therapists assessed stroke impact on participants and their job; co-ordinated NHS/employer/other stakeholders' support; negotiated job accommodations, monitored return to work and explored alternatives if return to work were unfeasible. Usual care involved NHS rehabilitation provided by community teams and medical follow-up. Primary outcome: self-reported return to work 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. Between 1 June 2018 and 7 March 2022, 583 participants [mean age 54 years (standard deviation 11.1), 69.0% male, mean 29.9 days (standard deviation 20.0) post stroke, 452 (82.8%) ischaemic stroke] were randomised to Early Stroke Specialist Vocational Rehabilitation (n = 324) or usual care (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 return to work between groups at 12 months [165/257 (64.2%) Early Stroke Specialist Vocational Rehabilitation vs. 117/197 (59.4%) usual-care, adjusted odds ratio 1.12 (95% confidence interval 0.8 to 1.87), p = 0.3582]. Similar proportions of adverse events occurred in both groups [40/241 (16.6%) attended accident and emergency, 24/244 (9.1%) hospital admissions, 6/266 (2.3%) work accidents at 12 months]. Exploratory subgroup analyses indicated Early Stroke Specialist Vocational Rehabilitation potentially benefits older people (60+), and those with two or more post-stroke impairments. 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 Early Stroke Specialist Vocational Rehabilitation had higher costs [incremental cost £1337 (95% confidence interval -1113 to 3787) and slightly more favourable incremental quality-adjusted life-years of 0.019 (95% confidence interval -0.012 to 0.051)]. Early Stroke Specialist Vocational Rehabilitation was valued by participants and service managers. In contrast, usual-care participants reported limited or no vocational rehabilitation and poor communication. Intervention compliance was achieved for 244 (75.3%) participants. Mentor support for occupational therapies appeared to increase fidelity. Most participants had mild-moderate stroke, unlike our feasibility evaluation which informed the sample size (powered to detect an absolute 13% difference in return to work). More people return to work than anticipated. There was significant loss to follow-up for primary, secondary and health economic outcomes. Employers proved difficult to recruit and engage. REturn To work After stroKE was unable to demonstrate an effect or cost effect of Early Stroke Specialist Vocational Rehabilitation on return to work 12 months post randomisation. The COVID-19 pandemic influenced employer behaviour, and remote working diluted Early Stroke Specialist Vocational Rehabilitation mechanisms in a predominantly mild-moderate sample, many of whom were able to self-navigate return to work. Research is needed to confirm Early Stroke Specialist Vocational Rehabilitation benefits in people marginalised by age or post-stroke impairment, and determine what interventions benefit younger stroke survivors. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/130/11. Many people cannot REturn To work After stroKE and there is little National Health Service support for this. We developed early, stroke specialist vocational rehabilitation to support people to return to and remain in work. This was available for up to 1 year. We recruited working people aged 18 or over, within 12 weeks of new stroke and allocated at random, whether they received the new rehabilitation in addition to usual National Health Service care or usual National Health Service care only. Twelve months later we compared the potential benefits of the new rehabilitation to its costs in terms of how many in each group had returned to work. The trial recruited 583 stroke patients from 21 hospitals. Most people recruited had mild–moderate stroke. Although 5% more people returned to work with the new rehabilitation, this difference was not statistically significant and might have happened by chance rather than because of the new rehabilitation. Overall, the new rehabilitation was found unlikely to offer the National Health Service value for money in the short term. Additional exploratory analysis suggested older people and those with more stroke disability might be more likely to benefit from the new rehabilitation. However, more research is needed to confirm these findings. The new rehabilitation was delivered as intended and valued by stroke survivors and National Health Service managers. Stroke survivors who received usual National Health Service care only, received little rehabilitation, which was poorly co-ordinated with limited or no vocational rehabilitation. The COVID-19 pandemic came at a critical point. It made flexible, home-based working the norm, particularly for managerial roles, reducing the effect of the new rehabilitation. People who sustain stroke with few lasting disabilities may be able to return to work without specialist support. However, further research is needed to confirm this and determine whether this applies to people of all ethnicities and job types.
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arXiv · 2023-07-20
arXiv · 2024-09-24