Trials (Jul 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

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

DOI
https://doi.org/10.1186/s13063-024-08183-w
Journal volume & issue
Vol. 25, no. 1
pp. 1 – 20

Abstract

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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.

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