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

Abstract

IntroductionThe 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 analysisThe 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 disseminationEthics 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 numberNCT03450460; Pre-results.

Where Does Value Lie in Peer Support? An Exploratory Discussion of the Theories and Methods Underpinning Effective Research in Peer Support

“…Another used focus groups as well as quantitative data collections to analyze peer support for psychological problems (Aschbrenner et al, 2016). In addition, an RCT was supplemented with a final interview program for peer support for people with brain injury, showing that other factors beyond the RCT needed investigation (Munce et al, 2019). These studies demonstrate that quantitative and qualitative data collection can be used to overcomes one of the chief criticisms of RCTs by Deaton and Cartwright (2017) that many lack an understanding of the context of outcomes of interventions.…”

Using the Exploratory Sequential Design for Complex Intervention Development: Example of the Development of a Self-Management Program for Spinal Cord Injury

“…Matching may be an important consideration, and given the collective findings of this research, peer leaders and recipients should be matched based on level of injury and age. Matching based on sex, mechanism of injury, marital status, and life situation has been previously described as important to consider in peer support for individuals with acquired brain injury (Munce et al, 2019).…”

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

“…This design can aid in the explanation of RCT results and generation of hypotheses regarding the mechanisms of action of an intervention [30]. An integrated knowledge translation (IKT) approach guided the overall study and helped finalize the protocol for the RCT [29,31]. The pilot feasibility RCT was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines, while the qualitative component followed a qualitative descriptive approach and data were reported in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines [32,33].…”

“…Peer support programs may be rooted in theoretical frameworks such as Bandura's social cognitive theory and its theoretical concept of self-efficacy [12]. Self-efficacy is an early step in the causal pathway of behavior change and increasing it is necessary for behavior change [12,29]. Thus, mechanisms such as using the mastery experience of others, role modeling, social persuasion, and reframing of physiological and affective states, which all affect self-efficacy, may serve to support the behavior changes of participants in peer support programs by using peer mentors as a gateway for increasing self-efficacy [12].…”