Using an integrated knowledge translation approach to inform a pilot feasibility randomized controlled trial on peer support for individuals with traumatic brain injury: A qualitative descriptive study.

INTRODUCTION: Traumatic brain injury (TBI) is estimated to affect 10 million people annually, making it a leading cause of morbidity and mortality worldwide. One cost-effective intervention that has been shown to minimize some of the negative sequelae after TBI is peer support. However, the evidence supporting the benefits of peer support for individuals with TBI is sparse and of low quality. Integrated knowledge translation (iKT) may be one approach to optimizing the evaluation of peer support programs among individuals with TBI. Therefore, the objectives are: (1) To understand key informants' perspectives of the barriers and facilitators of participating in peer support research and programs among individuals with TBI; (2) to understand key informants' perspectives on the perceived impacts of peer support programs on individuals with TBI; and, (3) to demonstrate how an iKT approach can inform the development and implementation of a pilot feasibility randomized controlled trial (RCT). METHODS: A qualitative descriptive approach using one-on-one semi-structured interviews was used. Purposive sampling of 22 key informants included 8 peer support mentors, 4 individuals with TBI who received peer support, 3 caregivers of individuals with TBI, 4 peer support program staff, and 3 academics in peer support and/or TBI. RESULTS: There were five main themes related to the barriers and facilitators to participating in peer support research and programs: knowledge, awareness, and communication; logistics of participating; readiness and motivation to participate; need for clear expectations; and matching. There were three main themes related to the perceived impact of peer support: acceptance, community, social experiences; vicarious experience/learning through others: shared experiences, role-modelling, encouragement; and "I feel better." Discussions with our Research Partner led to several significant adaptations to our trial protocol, including removing the twice/week intervention arm, shortening of the length of trial, and changing the measure for the community integration outcome. DISCUSSION/CONCLUSION: This is the first study to use an iKT approach to inform a trial protocol and the first to assess the barriers and facilitators to participating in peer support research.

A Pilot Feasibility Randomized Controlled Trial on the Ontario Brain Injury Association Peer Support Program.

BACKGROUND: The long-term consequences of traumatic brain injury can create major barriers to community integration. Peer support represents a sustainable model of support across this transition. The objective of the current study was to determine the feasibility of conducting a randomized controlled trial on the Ontario Brain Injury Association Peer Support Program and the preliminary effectiveness of the program on community integration, mood, health-related quality of life, and self-efficacy; Methods: A pilot feasibility randomized controlled trial with an embedded qualitative component was conducted. Mentees with moderate-to-severe traumatic brain injury (n = 13) were randomized to a weekly intervention or waitlist control group. Interviews were conducted with a subset of mentees and peer mentors (n = 10). Integration of the quantitative and qualitative data was completed using a joint display approach; Results: No statistically significant results were found for community integration, mood, or self-efficacy; however, changes in these outcomes were accompanied by moderate-to-large effect sizes. Within health-related quality of life, the mean pain score of the intervention group was significantly lower than that of the control group at the two-month timepoint but not at completion. Interviews revealed proximal improvements in knowledge, skills, and goals, and identified two domains related to trial acceptability: (1) environmental context and resources, and (2) reinforcement; Conclusions: Given the conceivable importance of proximal improvements in domains such as knowledge, skills, and/or goals for the attainment of more distal outcomes, modifications to the existing Peer Support Program may be warranted. The introduction of program recommendations which promote discussion around particular domains may help facilitate long-term improvements in health outcomes.

Ontario Brain Injury Association Peer Support Program: a mixed methods protocol for a pilot randomised controlled trial.

INTRODUCTION: The objective of this study is to conduct a pilot randomised controlled trial (RCT) of the Ontario Brain Injury Association (OBIA) Peer Support Program. The RCT is designed to evaluate the effectiveness and dose-response of the Peer Support Program in improving participation and mood for people with moderate-to-severe traumatic brain injury compared with a wait-list control group. METHODS AND ANALYSIS: The proposed research is a three-phase, mixed methods pilot RCT. Consistent with an integrated knowledge translation approach, the study design has been informed in consultation with the knowledge user (ie, OBIA). It will include an initial qualitative examination of barriers and enablers to the trial implementation (phase 1), a pilot RCT (phase 2) and conclude with a qualitative component (phase 3). A qualitative descriptive approach will be adopted for both qualitative phases of the study (n=20-25) and thematic analysis will be used. The 6 months phase-2 trial will be conducted with 60 participants. These participants will be randomised to one of three groups: a twice a week programme (n=20), a once a week programme (n=20) or the wait-list control group (n=20). The feasibility of participant recruitment and retention, data collection, as well as participant adherence to the OBIA Peer Support Program will be evaluated. The primary outcome measure will be participation, as measured by the Participation Assessment with Recombined Tools-Objective. Other proposed outcomes of interest will include mood, health-related quality of life and self-efficacy. ETHICS AND DISSEMINATION: Ethics approval will be obtained from the principal author's institution (University Health Network Research Ethics Board). The results of this study will inform the development of a larger scale RCT and will inform future iterations of the OBIA Peer Support Program including a revised programme curriculum. TRIAL REGISTRATION NUMBER: NCT03450460; Pre-results.