Randomised pragmatic waitlist trial with process evaluation investigating the effectiveness of peer support after brain injury: protocol

INTRODUCTION: Traumatic brain injury (TBI) is an important global health problem. Formal service provision fails to address the ongoing needs of people with TBI and their family in the context of a social and relational process of learning to live with and adapt to life after TBI. Our feasibility study reported peer support after TBI is acceptable to both mentors and mentees with reported benefits indicating a high potential for effectiveness and likelihood of improving outcomes for both mentees and their mentors. OBJECTIVES: To (a) test the effectiveness of a peer support intervention for improving participation, health and well-being outcomes after TBI and (b) determine key process variables relating to intervention, context and implementation to underpin an evidence-based framework for ongoing service provision. METHODS AND ANALYSIS: A randomised pragmatic waitlist trial with process evaluation. Mentee participants (n=46) will be included if they have moderate or severe TBI and are no more than 18 months post-injury. Mentor participants (n=18) will be people with TBI up to 6 years after injury, who were discharged from inpatient rehabilitation at least 1 year prior. The primary outcome will be mentee participation, measured using the Impact on Participation and Autonomy questionnaire after 22 weeks. Primary analysis of the continuous variables will be analysis of covariance with baseline measurement as a covariate and randomised treatment as the main explanatory predictor variable at 22 weeks. Process evaluation will include analysis of intervention-related data and qualitative data collected from mentors and service coordinators. Data synthesis will inform the development of a service framework for future implementation. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the New Zealand Health and Disability Ethics Committee (19/NTB/82) and Auckland University of Technology Ethics Committee (19/345). Dissemination of findings will be via traditional academic routes including publication in internationally recognised peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12619001002178.