title: Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.
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
  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-faceVs 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial is registered ISRCTN Number 38581822.
authors.affiliation: Division of Rehabilitation and Ageing, School of Medicine, Medical School Queen's Medical Centre, B-Floor, Nottingham, NG7 2UH UK.
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Radford
authors.affiliation: Division of Rehabilitation and Ageing, School of Medicine, Medical School Queen's Medical Centre, B-Floor, Nottingham, NG7 2UH UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Phillips
authors.affiliation: Nottingham, UK.
authors.forename: Trevor
authors.initials: T
authors.lastname: Jones
authors.affiliation: Lancashire Clinical Trials Unit, School of Health, University of Central Lancashire, Brook Building, Room 217, Preston, PR1 2HE UK.
authors.forename: Ali
authors.initials: A
authors.lastname: Gibson
authors.affiliation: Lancashire Clinical Trials Unit, School of Health, University of Central Lancashire, Brook Building, Room 217, Preston, PR1 2HE UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Sutton
authors.affiliation: Lancashire Clinical Trials Unit, School of Health, University of Central Lancashire, Brook Building, Room 217, Preston, PR1 2HE UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Watkins
authors.affiliation: Health Economics Group, Norwich Medical School, University of East Anglia, CD Annex 1.13, Norwich Research Park, Norwich, NR4 7TJ UK.
authors.forename: Tracey
authors.initials: T
authors.lastname: Sach
authors.affiliation: Nottingham Clinical Trials Unit, Nottingham Health Science Partners, C Floor, South Block, QMC, Nottingham, NG7 2UH UK.
authors.forename: Lelia
authors.initials: L
authors.lastname: Duley
authors.affiliation: Division of Rehabilitation and Ageing, School of Medicine, Medical School Queen's Medical Centre, B-Floor, Nottingham, NG7 2UH UK.
authors.forename: Marion
authors.initials: M
authors.lastname: Walker
authors.affiliation: School of Health Sciences, University of Nottingham Queen's Medical Centre (QMC), A Floor, Nottingham, NG7 2UH UK.
authors.forename: Avril
authors.initials: A
authors.lastname: Drummond
authors.affiliation: Trauma Science, Royal London Hospital, Ward 12D, Whitechapel, E1 1BB London UK.
authors.forename: Karen
authors.initials: K
authors.lastname: Hoffman
authors.affiliation: Academic Department of Rehabilitation Medicine, Leeds Institute of Molecular Medicine, University of Leeds, Level D, Martin Wing, Leeds General Infirmary, Leeds, LS1 3EX UK.
authors.forename: Rory
authors.initials: R
authors.lastname: O'Connor
authors.affiliation: Lancashire Clinical Trials Unit, School of Health, University of Central Lancashire, Brook Building, Room 217, Preston, PR1 2HE UK.
authors.forename: Denise
authors.initials: D
authors.lastname: Forshaw
authors.affiliation: Preston Neuro-Rehab Unit, Lancashire Teaching Hospitals NHS Trust, 32A Watling St, Preston, Lancashire PR2 8DY UK.
authors.forename: David
authors.initials: D
authors.lastname: Shakespeare
keywords: Feasibility; Occupational therapy; Randomised controlled trial; Return to work; Traumatic brain injury; Vocational rehabilitation