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

Abstract

BackgroundOver 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/designMixed 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.DiscussionTo 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.Trial registrationThe trial is registered ISRCTN Number 38581822.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-015-0017-z) contains supplementary material, which is available to authorized users.

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

“…Even though returning to work has proven important for long-term ABI survival and increased levels of quality of life [ 10 ], standardized evidence-based VR programs targeting patents with ABI have been lacking [ 11 – 13 ]. One very interesting feasibility randomized controlled trial (RCT) protocol has been published regarding brain injury and return to work; however, this protocol involved patients with a traumatic brain injury exclusively [ 14 ]. It has previously been shown that support from specialized VR teams help patients with ABI returning to work post injury [ 1 , 2 ].…”

Can a Complex Vocational Rehabilitation Intervention Be Delivered With Fidelity? Fidelity Assessment in the Fresh Feasibility Trial

“…Inclusion criteria were people aged 16 years or above, admitted to one of three major trauma centres for 48 hours or more, with a new TBI (within 8 weeks) and who were in paid or unpaid work or full-time education prior to injury. Full eligibility criteria in the FRESH RCT are explained elsewhere (46). Clinical records and intervention session case report forms (CRFs) were collected for every intervention participant (n = 38).…”

Vocational rehabilitation to enhance return to work after trauma (ROWTATE): protocol for a non-randomised single-arm mixed-methods feasibility study

“…The intervention has been informed by similar interventions previously developed by our team for patients with traumatic brain injury and stroke [60,61]. It has been developed by a multi-disciplinary team comprising OTs, clinical and neuropsychologists, a psychiatrist, vocational rehabilitation experts, a general practitioner, specialists in rehabilitation and trauma medicine, social scientists and patient representatives.…”