Ontario Brain Injury Association (OBIA) Peer Support Program
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Most people with moderate or severe TBI have difficulty returning to their usual social roles
      and activities. The OBIA has developed a program where peers (other individuals living with
      TBI) coach or mentor those with more recent brain injury. The objective of this project is to
      evaluate the feasibility of measuring the impact of the OBIA Peer Program on social
      participation and mood compared to a control group who have not received peer support yet.

      The proposed study will involve three phases. It will begin with a qualitative component
      (stakeholder interviews), then a pilot RCT, and end with more interviews to explore the
      success of the study intervention. A qualitative descriptive approach will be used at these
      first and last phases of the study. In Phase 1, interviews will be conducted with
      approximately 15 participants including individuals with moderate to severe TBI, caregivers,
      Mentors, OBIA staff members, and health researchers. The proposed Phase 2 will be a clinical
      trial, conducted with 60 participants. These participants will be randomized to one of three
      groups: a twice a week Program (n=20), a once a week Program (n=20), or the wait list control
      group (n=20). For Phase 3, a sub group of approximately 25 participants from Phase 2 who
      participated in the OBIA Peer Support Program will be asked to participate in a one-on-one,
      telephone/Skype interview. A sub-group of Mentors will also be asked to participate in a
      one-on-one, telephone/Skype interview.

      This research project will address the highest priority areas of "strategies to enhance
      social participation and community life (personal relationships)" and "psychological
      strategies to improve mood, depression, and irritability", as identified in the ONF's Request
      for Proposals on "Addressing Evidence Gaps in Moderate to Severe TBI Rehabilitation". The
      study will provide important results to inform a RCT (of appropriate size) on the impact of
      peer support on the social participation and mood of individuals with moderate to severe TBI.
      This study will then provide the best evidence to support the recommendation on "a
      peer-supported relationship model of intervention", and inform future versions of the
      INESSS-ONF Guideline.
    

Detailed description: 
      Phase 1 - Understanding the Enablers, Barriers of Implementing the Trial Protocol

      Specific Objective: To understand the perceived enablers and barriers of implementing the
      peer support trial protocol, including the perceived enablers and barriers to participant
      recruitment, retention, adherence, and data collection, of implementing the selected outcomes
      measures, and of participating in the trial, from the perspective of stakeholders (knowledge
      users) including individuals with moderate to severe TBI, caregivers, OBIA Peer Support
      Program Mentors, OBIA staff members who are a part of the Peer Support Program, health
      services and knowledge translation (KT) researchers with expertise in TBI, and methodologists
      with expertise in clinical trials; Hypothesis: A better understanding of the perceived
      enablers and barriers of implementing the peer support trial protocol will enhance the
      effectiveness of the intervention and feasibility of the trial in Phase 2 and results will be
      used to refine the research protocol for the RCT, if necessary.

      Participants and recruitment: A purposive sampling of each of the different stakeholder
      groups will be used. The OBIA Peer Support Program Database will be used to recruit the
      Partners (including caregivers) and Mentors. On-line searches and/or the contacts of the
      Principal Investigators will be used to recruit the OBIA staff members and the
      researchers/methodologists. We will aim to recruit a total of 15 key informants for Phase 1.
      Individuals who are interested in participating in the study will contact the Research
      Coordinator via telephone or email to gain further information about the study. The
      eligibility criteria of all participants will be confirmed by the Research Coordinator. This
      process will be followed for all phases of the study.

      Data collection: participants will take part in a one-on-one, semi-structured telephone/Skype
      interview lasting approximately 45-60 minutes. All interviews will be digitally recorded and
      transcribed verbatim for data analysis. During transcription, any identifying information
      will be removed and the participant will be assigned a coded identifier.

      Data analysis: analysis will be conducted using inductive thematic analysis as described by
      Braun and Clark (2006). The analysis will assess the perceived enablers and barriers to
      participant recruitment, retention, adherence, and data collection, of implementing the
      selected outcomes measures, and of participating in the OBIA Peer Support Program and the
      trial itself. To facilitate the organization and analysis of the qualitative data, the
      Principal Investigator's/Research Coordinator's reflective notes from the interviews, as well
      as the transcripts, will be entered into NVivo v.11.

      Phase 2 - Evaluating the Feasibility of the Trial Protocol, Conducting a (Pilot) Randomized
      Controlled Feasibility Trial

      Specific Objective: a) To evaluate the feasibility of participant recruitment and retention,
      data collection, as well as participant adherence to the OBIA Peer Support Program; b) To
      estimate effect sizes of the immediate impact of the twice/week versus once/week OBIA Peer
      Support Program compared to a wait list control group on social participation (primary
      outcome), mood, HRQoL, and self-efficacy (secondary outcomes); Hypotheses: a) It is expected
      that adequate (i.e., ≥75%) recruitment, retention and adherence to the OBIA Peer Support
      Program will be achieved; b) It is expected that the six-month OBIA Peer Support Program
      delivered twice weekly will lead to greater mean improvement, on measures of social
      participation, mood (i.e., depressive symptoms), HRQoL, and self-efficacy, than the same
      program delivered once weekly or a wait list control intervention (i.e., a dose response
      effect will be observed); c) It will be possible to estimate the magnitude of effect to allow
      the sample size calculation for a definitive trial; Significance: The results of the
      currently proposed research will support a future definitive RCT.

      Participants and recruitment: eligible Partner participants will include community-based
      (i.e., no longer participating in a comprehensive rehabilitation program) individuals who
      have a moderate to severe TBI. Partners will be recruited via an online advertisement posted
      on the OBIA website as well as the websites of the 14 participating brain injury
      associations. Mentor participants may also be recruited from the OBIA Peer Support Program
      Database. We will aim to recruit a total of 60 Partners (i.e., n=20 participants per group)
      and 20-40 Mentors (those paired with partners in the intervention arm) for Phase 2.

      Intervention and Control Groups: Participants in the intervention groups will take part in
      the OBIA Peer Support Group, receiving either twice a week (i.e., two 20-40 minute calls) or
      once a week (i.e., one 20-40 minute call) support. In keeping with an average duration of
      support, and for the purposes of the currently proposed study, the intervention duration will
      be 6 months. Participants in the control group will be assigned to a wait list. They will
      receive the OBIA Peer Support Program after the intervention group (i.e., after 6 months).
      This assignment does not represent a significant variation in the usual intake procedure, as
      the OBIA Peer Support Program already maintains a wait list (personal communication).

      Sample Size, Randomization, and Blinding: since this is a feasibility study, a formal sample
      size calculation will not be performed. The recruitment of 20 participants in each arm of the
      trial is judged to be feasible and will produce a robust and useful amount of data. Partner
      participants who meet the inclusion and exclusion criteria and have provided informed consent
      to take part in the trial will be randomized to either the intervention (twice/week or
      once/week Program) or the wait list control groups. Mentors will be assigned to those
      randomized into the intervention arms by the OBIA Peer Support Program using their usual
      methods. A web-based randomization service with secure password protected login using random
      variable block-size will be used. Due to the nature of the intervention, blinding of the
      Partners and Mentors will not be possible. However, the processes of outcome assessment and
      data analysis will be blinded.

      Data collection: baseline data including demographic and descriptive information (e.g., age,
      sex, severity of injury, marital status), as well as the following outcomes measures
      described below, will be captured prior to randomization: social participation using the
      Community Integration Questionnaire (CIQ); mood (i.e., depressive symptoms) using the
      nine-item Patient Health Questionnaire (PHQ-9); health-related quality of life (HRQoL) using
      the Short Form-12 Health Survey (SF-12); self-efficacy using the TBI Self-efficacy
      Questionnaire. Follow-up assessments for the outcome measures will occur at 6 weeks, 3
      months, and 6 months. Participants will have the option to complete their baseline
      demographic and descriptive information and outcome measures as well as their follow-up
      assessments themselves (i.e., paper-based and mailed back to the research team), by
      telephone, or on-line via Survey Monkey®.

      Data analysis: Quantitative Component: baseline characteristics (e.g., age, sex, severity of
      injury, marital status, etc.) will be described and any differences between the three groups
      will be compared using means/medians and frequencies and proportions. As this is a
      feasibility study, and the ability to collect data is being tested, no data imputation will
      be performed to account for missing data. The feasibility of recruitment will be based on
      whether 60 participants (i.e., 20 participants in each arm of the trial) can be enrolled in
      the trial during the 6-month recruitment period. The number of individuals who provide
      informed consent per month will also be calculated. The feasibility of retention will be
      assessed by calculating the proportion of participants with complete data on each outcome
      measure at 6 weeks, 3 months, and 6 months. To evaluate participant adherence, the proportion
      of twice-weekly and weekly sessions attended by the participants will be calculated. The
      proportion of participants who withdraw from the intervention at 6 weeks, 3 months, and 6
      months will be calculated along with the reason(s) for withdrawing. The feasibility threshold
      will be set at >75% for recruitment, retention, and adherence (to the intervention). To
      evaluate changes between groups, the analysis plan will focus on mean change scores and
      confidence intervals (i.e., mixed-design analysis of variance model) for the outcome measures
      described above. Effect sizes will be calculated via Cohen d to reflect the impact of the
      OBIA Peer Support Program on social participation, mood, HRQoL, and self-efficacy.

      UPDATE TO PHASE 2 AFTER COMPLETING PHASE 1

      After the completion of the phase 1 study and prior to implementing the phase 2 pilot RCT,
      the following procedures were changed/finalized for the RCT: 1) the study will only include
      the once/week intervention arm and a wait-list control (participant recruitment expectations
      adjusted accordingly to 40 partners (20 per arm) and 20 mentors (to be matched with those in
      the intervention arm); 2) the trial length has been reduced from 6 months to 4 months, and
      data collection points now include baseline, 2 months, and 4 months; 3) The Short Form-20
      Health Survey (SF-20) will replace the SF-12 outcome measures; and, 4) data collection will
      be done by telephone.

      Phase 3 - Exploring the Impact and Acceptability of the OBIA Peer Support Program and the
      Trial Protocol

      Specific Objective: To explore the impact and acceptability of the OBIA Peer Support Program
      and the trial itself from the perspective of Partners and Mentors; Hypothesis: It is expected
      that the OBIA Peer Support Program will be acceptable to both the Partners and Mentors and
      that an increased understanding of the OBIA Peer Support Program and the trial itself will be
      achieved; Significance: The results of Phase 3 will lead to an understanding of the "active
      ingredients" or mechanisms that are associated with improved outcomes and the impact of
      "dosage" of interactions. Furthermore, the results of Phase 3 will refine and improve future
      iterations of the OBIA Peer Support Program and the implementation of the definitive RCT.

      Participants and recruitment: Purposive sampling will be used to recruit intervention group
      Partner participants in Phase 3 (e.g. to ensure participants with a range of severity of
      TBI), and all prticipating Mentors will be approached about participating in the interviews.
      Recruitment of participants will cease once data saturation has been achieved, which is the
      point when successive interviews become repetitive and no new responses or themes emerge. We
      will aim to recruit a total of 25 Partners and Mentors for Phase 3.

      Data collection: participants will take part in a one-on-one, semi-structured telephone/Skype
      interview lasting approximately 45-60 minutes about their experience with the RCT. All
      interviews will be digitally recorded and transcribed verbatim for data analysis. During
      transcription, any identifying information will be removed and the participant will be
      assigned a coded identifier.

      Analysis Plan: analysis will be conducted using inductive thematic analysis as described by
      Braun and Clark (2006) and will assess participants' experiences with the intervention and
      the trial protocol itself (i.e., the impact and acceptability of the program
      itself/intervention and the trial protocol itself). To facilitate the organization and
      analysis of the qualitative data, the Principal Investigator's/Research Coordinator's
      reflective notes from the interviews, as well as the transcripts, will be entered into NVivo
      v.11.
    

Intervention name(s): Peer support
Intervention type(s): Behavioral
Intervention description(s): The Program matches volunteer Mentors and Partners for a series of one-to-one interactions that focus on the discussion and resolution of problems or issues (i.e., problem solving) related to one or several key topic areas including family and friends, resources, life changes or challenges, (health care) professionals, social/recreational activities, work/employment/training/volunteering, the brain injury itself, emotions or feelings, and other issues.27 Once the match is established, the Mentor and Partner communicate with one another primarily by telephone until the problems or issues are either resolved or a referral to another service is made (i.e., counselling or community support services). For some partnerships, communication by email or video conferencing is used.27 Most telephone calls last between 20 and 40 minutes (personal communication) and are held weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: peer support; feasibility trial; mixed methods