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

Abstract

Background: An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care).

Methods: This study is an interventional, two-arm, six-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The six- to nine-month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed.

Discussion: This study consists of a comprehensive multidiciplinary VR intervention involving several parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers.

Trial registration: ClinicalTrials.gov, NCT03086031 . Registered on 21 March 2017.

Keywords: Caregiver intervention; Randomized controlled trials; Return to work; Study protocol; Traumatic brain injury; Vocational rehabilitation.

Conflict of interest statement

Ethics approval and consent to participate

The study has been reported to the Danish Data Protection Agency (registration no. 2016-41-4950). The Regional Ethical Committee of Region Zealand, Denmark, has stated that the study does not need their approval (komitélovens §§1 and 2). The study will be carried out according to the local legal and regulatory requirements and data will be handled according to the guidelines given by the Danish Personal Data Protection Agency.

All participants must give written and oral informed consent to participate in the study, including their consent to publish the results. If any participants are aged under 18 years, they will provide a verbal acceptance while their parents will complete the written consent.

Consent for publication

Not applicable in this section.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

A flow chart of the study

Fig. 2

Content for the schedule of enrollment, interventions, and assessments

Fig. 3

The x-axis depicts the average hours at work/study per week for the conventional VR treatment and the y-axis the average surplus obtained from the VR intervention. The colors indicate the study power at level alpha 0.05 under these expectations for a study with 42 + 42 = 84 participants. The black line indicates the combinations obtaining a power of 0.8