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Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial

Radford, Kathryn A.; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O’Connor, Rory; Forshaw, Denise; Shakespeare, David

Authors

Julie Phillips

Trevor Jones

Ali Gibson

Chris Sutton

Caroline Watkins

Tracey Sach

Lelia Duley

Marion Walker

AVRIL DRUMMOND avril.drummond@nottingham.ac.uk
Professor of Healthcare Research

Karen Hoffman

Rory O’Connor

Denise Forshaw

David Shakespeare



Abstract

Background: Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial.
Methods/design: Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face Vs postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a larger trial.
Discussion: To our knowledge, this is the first feasibility randomised controlled trial of a vocational rehabilitation health intervention specific to traumatic brain injury. The results will inform the design of a definitive trial.

Journal Article Type Article
Publication Date Jun 17, 2015
Journal Pilot and Feasibility Studies
Electronic ISSN 2055-5784
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 1
APA6 Citation Radford, K. A., Phillips, J., Jones, T., Gibson, A., Sutton, C., Watkins, C., …Shakespeare, D. (2015). Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial. Pilot and Feasibility Studies, 1, https://doi.org/10.1186/s40814-015-0017-z
DOI https://doi.org/10.1186/s40814-015-0017-z
Keywords Occupational therapy, Return to work, Traumatic brain injury, Vocational rehabilitation, Feasibility, Randomised controlled trial
Publisher URL http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-015-0017-z
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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