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Lookup NU author(s): Dr Laura Graham
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2024.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.
Author(s): 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, Kettlewell J, Morriss R, das Nair R, Richardson D, Smith M, Timmons S, Wright-Hughes A, Radford K
Publication type: Article
Publication status: Published
Journal: Trials
Year: 2024
Volume: 25
Issue: 1
Online publication date: 02/07/2024
Acceptance date: 17/05/2024
Date deposited: 16/07/2024
ISSN (electronic): 1745-6215
Publisher: BioMed Central Ltd
URL: https://doi.org/10.1186/s13063-024-08183-w
DOI: 10.1186/s13063-024-08183-w
Data Access Statement: To maintain the scientific integrity of the study, data will not be released prior to the end of the study, either for study publication or oral presentation purposes, without the permission of the TSC. Access to data or sharing data with third parties will be subject to approval by the study funder, sponsor and TSC. A data sharing agreement will be required prior to access/sharing of any study data. Data will be kept for a minimum of 7 years following the end of the trial. During the archiving period (i.e. after the TSC has been disbanded at the end of the trial and before destruction of data), any requests for access to or copies of data will be considered by all collaborators in consultation. The sponsor will be the final arbiter of whether any disclosure/sharing should be agreed.
PubMed id: 38956682
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