Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial

Kendrick, Denise; Lindley, Rebecca; Blackburn, Lauren; Roadevin, Cristina; Thompson, Ellen; Andrews, Isabel; Anwar, Fahim; Brooks, Adam; Carlton, Edd; Crouch, Robert; Day, Florence; Fallon, Steve; Farrin, Amanda; Graham, Laura; Hoffman, Karen; Howell, Rebekah; Holmes, Jain; James, Marilyn; Jones, Trevor; Kellezi, Blerina; Kettlewell, Jade; Morriss, Richard; das Nair, Roshan; Richardson, Davina; Smith, Matthew; Timmons, Stephen; Wright-Hughes, Alexandra; Radford, Kathryn

Abstract

Background
Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma.

Methods
ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants’ self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere.

Discussion
This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS.

Trial registration
ISRCTN: 43115471. Registered 27/07/2021.

Citation

Kendrick, D., Lindley, R., Blackburn, L., Roadevin, C., Thompson, E., Andrews, I., Anwar, F., Brooks, A., Carlton, E., Crouch, R., Day, F., Fallon, S., Farrin, A., Graham, L., Hoffman, K., Howell, R., Holmes, J., James, M., Jones, T., Kellezi, B., …Radford, K. (2024). Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial. Trials, 25(1), Article 439. https://doi.org/10.1186/s13063-024-08183-w

• Journal Article Type: Article
• Acceptance Date: May 17, 2024
• Online Publication Date: Jul 2, 2024
• Publication Date: Jul 2, 2024
• Deposit Date: Jul 4, 2024
• Publicly Available Date: Jul 4, 2024
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 25
• Issue: 1
• Article Number: 439
• DOI: https://doi.org/10.1186/s13063-024-08183-w
• Keywords: Return to work, Quality of life, Occupational therapy, Employment, Psychology, Vocational rehabilitation, Injury, Trauma, Health economics
• Public URL: https://nottingham-repository.worktribe.com/output/36872389
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08183-w