A Pilot Feasibility Randomized Controlled Trial on the Ontario Brain Injury Association Peer Support Program
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants
2.3. Intervention
2.4. Randomization and Blinding
2.5. Outcome Measures for the Pilot Feasibility Randomized Controlled Trial
2.5.1. Feasibility Outcomes
2.5.2. Community Integration (Primary Outcome)
2.5.3. Mood (Secondary Outcome)
2.5.4. Health-Related Quality of Life (Secondary Outcome)
2.5.5. Self-Efficacy (Secondary Outcome)
2.6. Data Collection and Analysis
2.6.1. Pilot Feasibility Randomized Controlled Trial (Quantitative Component)
2.6.2. Interviews (Qualitative Component)
2.7. Integration of Data Sets
3. Results
3.1. Quantitative Data
3.1.1. Recruitment, Adherence, and Retention
3.1.2. Community Integration
3.1.3. Mood
3.1.4. Health-Related Quality of Life
3.1.5. Self-Efficacy
3.2. Qualitative Data
3.2.1. Outcomes of Participating in Peer Support
Knowledge
I think talking about medications, like strategies and tools that we use to deal with our anxiety, our depression, our post-trauma, our stress. And, the fact that it’s a chronic thing. And our pain. Physical pain. My knee, his knee as well. Strategies, concrete things, a crutch or a wheelchair or prosthetic knee, that he uses.(ID #1006)
I wouldn’t necessarily say that she gave me more of an education but she reminded me about things that maybe I had forgotten about or that I stopped doing. Like vitamins for example, like I used to take omega-3 and I stopped.... so she kind of reminded me about that and now I’ve started taking the vitamins again which I found helpful before and now I’m finding helpful again.(ID #1005)
Skills
… [my peer mentor] also gave me some suggestions with organization in my house because we do a lot of laundry with little kids and she suggested these laundry tote containers.... she suggested these totes that were really helpful for her to organize her kids’ stuff. I was able to get hold of some and that helped me organize the laundry better and that was helpful.(ID #1005)
Beliefs about Capabilities
I know on several occasions there were things that I spoke to my mentor about, that were really helpful that I wasn’t feeling confident about… just stuff with the kids, like stuff where I thought maybe I was not doing a great job and I talked to [my peer mentor] and she was very validating… I know that that happened on several occasions that it was after talking with her it was just really helpful and reassuring.(ID #1005)
If you don’t have confidence in yourself, it’s going to make it more difficult. So, for me the confidence is a big issue and the program helped me do that.... I think confidence is a big issue. So, when you’re confident in talking to others, then it might help you a lot. The program helped me do that.(ID #1001)
Optimism
When I was a mentee, the one-on-one that I had with my mentor was so critical, because the issues were very specific to me and I needed somebody that [was] further along in the journey to help me figure it out. Like, “what’s going on.” Also, looking to them as hope, that I can get to wherever they are in that healing stage.(ID #1009)
Beliefs about Consequences
What I try to do is not to let them look back and talk about what they used to do before. My goal is try to go forward, things that they can do now.... People always are in awe about what they used to do before and they’re trying to get back their life in full. And it doesn’t work like that, because I used to do the same thing.... The brain cannot be rushed. It takes its own time.(ID #1001)
There’s this narrative that’s like, get the person back to work and at all costs, no matter what their quality of life or whatever. It’s all about work. And I appreciate that work is so much of our sense of identity before we’re injured. And it took me until I settled, so probably seven or eight years, to accept the fact that I wasn’t going to get an identity through working. And to give up on that narrative that all the therapists were pushing. I’m a lot happier now that I’m not following this narrative of what the therapists say.(ID #1008)
Reinforcement
It’s increased [my behavior and thinking and knowledge]. My mood, like I said. My motivation, my energy. Because, it’s a pleasant phone call. It improved my social [sic.]. I’m less anxious to talk to people on the phone. I’m more comfortable. I like it. I enjoy it. I enjoy the process.(ID #1006)
Goals
“My goal is to try to go forward, things that they can do now.... because the main thing with brain injury I find that people always look back.... So, I try to let them look forward, not to forget about their life, but they’ve got to put it on the back burner and focus on this now”.(ID #1001)
Social Influences
It was nice to know that there was [sic.] other people and that you’re not in your own little bubble by yourself and your issues are legitimate. It’s nice to have that social piece with people that really understand and are going through similar situations or at least have been through similar situations.(ID #1005)
Emotion
When I was partnered as the mentee, I really enjoyed that experience and I really liked both of my mentors. I felt it was easy to talk to the person, we had lots of things in common. Our conversations, generally speaking, were never boring. We would always talk for an hour, at least. Or it felt like that, unless one of us was sick. So, I just assumed that’s what it was going to be like when I got my own mentee, but it was the opposite of that. The first couple of conversations were good and since then it’s just been, I don’t know, we don’t have much in common. I guess I’m just a bit disappointed.(ID #1009)
3.2.2. Acceptability of the Randomized Controlled Trial
Reinforcement
Environmental Context and Resources
I think that because of my lack of energy maybe the quality of some of my answers towards the end weren’t as accurate or effective just [sic.]. Because I was so tired maybe I wasn’t giving the most accurate answers, if that makes sense.... And obviously I know it’s hard to break things up but for people that are recently injured that’s a really tricky piece, is the energy piece, the energy component.(ID #1005)
3.2.3. Integration of Quantitative and Qualitative Results
4. Discussion
4.1. Feasibility of Conducting an RCT of the OBIA Peer Support Program
4.2. Similarity of Results from the OBIA Peer Support Program to Previous Studies
4.3. Recommendations for Future Implementation of the OBIA Peer Support Program
4.4. Challenges Associated with Program Modifications and Future Outcome Measurement in Peer Support Studies
4.5. Strengths and Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Demographic Characteristic | Intervention Group, n = 6 | Waitlist Control Group, n = 7 | p-Value |
---|---|---|---|
Sex, n (%) | 0.853 a | ||
Male | 4 (66.7) | 5 (71.4) | |
Female | 2 (33.3) | 2 (28.6) | |
Age (years) | 0.047 b | ||
Mean/SD | 50.8 (12.92) | 35.6 (11.70) | |
Median/IQR | 49.5 (24) | 32 (19) | |
Marital status, n (%) | 0.422 a | ||
Married/common | 3 (50.0) | 3 (42.9) | |
Single/never married | 2 (33.3) | 4 (57.1) | |
Separated/divorced | 1 (16.7) | 0 (0.0) | |
Highest level of education, n (%) | 0.345 a | ||
Some high school or less | 0 (0.0) | 1 (14.3) | |
High school | 1 (16.7) | 0 (0.0) | |
Some college/CEGEP/trade school | 1 (16.7) | 1 (14.3) | |
Graduated from college/CEGEP/trade school | 2 (33.3) | 0 (0.0) | |
University undergraduate degree | 2 (33.3) | 1 (14.3) | |
Master’s or professional degree | 0 (0.0) | 3 (42.9) | |
Severity of brain injury, n (%) | 0.505 a | ||
Moderate | 2 (33.3) | 1(14.3) | |
Severe | 4 (66.7) | 5 (71.4) | |
Missing | 0 (0.0) | 1 (14.3) |
Peer Mentors (n = 6), n (%) | |
---|---|
Sex, n (%) | |
Male | 3 (50.0) |
Female | 3 (50.0) |
Age (years) | |
Mean/SD | 51.0 (8.17) |
Median/IQR | 53 (15) |
Marital status | |
Married/common | 3 (50.0) |
Single/never married | 2 (33.3) |
Separated/divorced | 1 (16.7) |
Highest level of education | |
Some high school or less | 0 (0.0) |
High school | 0 (0.0) |
Some college/CEGEP/trade school | 1 (16.7) |
Graduate from college/CEGEP/trade school | 2 (33.3) |
University undergraduate degree | 3 (50.0) |
Master’s or professional degree | 0 (0.0) |
Number of years as a peer mentor | |
<1 year | 2 (33.3) |
1–5 years | 3 (50.0) |
6–10 years | 1 (16.7) |
Mentee–Peer Mentor Pair | Total Sessions | Average Session Length (Minutes) |
---|---|---|
1 | 16 | 33 |
2 | 15 | 53 |
3 | 7 | 52 |
4 | 8 | 68 |
5 | 6 | 43 |
6 | 11 | 60 |
p-Values | |||
---|---|---|---|
Outcome | Time | Group | Interaction |
CIQ home integration * | 0.506 | 0.438 | 0.918 |
CIQ social integration | 0.636 | 0.787 | 0.214 |
CIQ productivity ** | |||
CIQ total | 0.956 | 0.657 | 0.373 |
PHQ9 | p-Values | ||
---|---|---|---|
Time | Group | Interaction | |
0.498 | 0.57 | 0.235 |
p-Values | |||
---|---|---|---|
Outcome | Time | Group | Interaction |
Physical functioning | 0.968 | 0.368 | 0.266 |
Role functioning * | 0.05 | 0.946 | 0.372 |
Social functioning | 0.566 | 0.648 | 0.447 |
Mental health | 0.955 | 0.79 | 0.332 |
Health perceptions | 0.401 | 0.966 | 0.554 |
Pain ** | 0.142 | 0.411 | 0.317 |
p-Values | |||
---|---|---|---|
Self-Efficacy | Time | Group | Interaction |
Social and community | 0.205 | 0.309 | 0.063 * |
Physical functioning | 0.478 | 0.485 | 0.95 |
Cognitive functioning | 0.616 | 0.305 | 0.456 |
Emotional regulation | 0.592 | 0.907 | 0.64 |
Total | 0.622 | 0.545 | 0.471 |
Main Outcomes | Quantitative Data | Qualitative Data | Integrated Findings |
---|---|---|---|
Feasibility | Recruitment Of the 48 interested mentees who made contact with researchers, 13 were deemed ineligible, 18 declined or did not respond after multiple consecutive attempts at communication, and 17 consented to participate. Of these 17 mentees, three were lost to follow-up before baseline and one was unable to be matched to a peer mentor and did not start the intervention. In total, 13 mentees participated in the trial: six in the intervention and seven in the control group. Adherence Adherence to the intervention ranged from 6 out of 18 (33%) weekly sessions logged to 16 out of 18 (89%) logged. The average call length was 51 min and ranged from 33 to 68 min across the six mentee–peer mentor pairs. Retention All mentee–peer mentor pairs completed the intervention. Data collection at each time point was completed for all but one pair. Baseline data for one mentee and peer mentor pair were missing as researchers were not informed of their match by the peer support program coordinator until after weekly correspondence had commenced. Of the six mentees and six peer mentor participants in the intervention group, five mentees and five peer mentors participated in the qualitative component. | Reinforcement Participation in research was described by mentees and peer mentors as a way to give back and both mentees and peer mentors indicated that they may benefit “in some way” from the research. The monetary incentive was described as a “bonus” but was not cited as the primary factor for participation. Mentees indicated that they received benefits from the program (e.g., social connection) which reinforced their participation. Other described improvements (e.g., increased energy and motivation) also reinforced mentees’ participation in the program. Environmental context and resources Most mentees and peer mentors indicated that the researchers had provided an acceptable environment for conducting the research. The length of surveys and scheduling logistics were also deemed acceptable; however, there was a relatively high turnover of peer support program coordinators. Mentees and peer mentors appreciated the ability to determine program frequency according to their needs (e.g., adhering to a biweekly rather than weekly schedule), including the ability to skip calls for holidays and/or vacations. Mentees and peer mentors also highly appreciated the flexibility offered in scheduling outcome measurement given that factors such as their energy and focus changed from day to day and affected both their ability to participate, as well as their responses to survey items. This latter phenomenon was concerning to one mentee who questioned whether the research was capturing outcomes accurately. | Some complementarity and some contradiction between quantitative and qualitative findings Recruitment challenges reduced the study’s sample size and resultant power for meaningful statistical comparisons (despite the numerous benefits of partaking in research and adequate environmental context cited by mentees and peer mentors). A high turnover of peer support program coordinators may have also impacted adherence as peer support coordinators were responsible for communicating concerns or making changes (i.e., rescheduling) when required and hence had an impact on participants’ experiences; however, in almost all cases, mentee–peer mentor pairs exchanged information to facilitate this process for themselves. Therefore, interruptions to scheduling due to factors such as holidays or vacations may have been a more significant issue with regard to intervention adherence. While the program was not delivered once per week for all participants (i.e., some mentees and peer mentors agreed to modify the intervention to meet less frequently), responsiveness to contextual factors (e.g., energy and memory) as well as flexibility conceivably served to promote adherence (i.e., according to the wishes of mentees and peer mentors), as well as increase retention. |
Community integration | No statistically significant change CIQ: overall mean score decreased from 16.1 (2.49) to 14.3 (6.65) for the intervention group and increased from 15.9 (4.88) to 17 (2.58) for the control group after four months (g = 0.58; CI = −0.591–1.751) | Knowledge Mentees and peer mentors both described the acquisition of knowledge as an outcome, including receiving and sharing knowledge of resources and tips for medications, mindfulness, and other everyday issues affected by brain injury (e.g., managing children). This also included reminders of existing knowledge, such as accessing brain injury resources or taking vitamins. Skills Mentees and peer mentors both experienced skill development due to the sharing of knowledge on multiple issues, including organization (e.g., using calendars and calendar reminders) and returning to work. Goals Both mentees and peer mentors described goals and goal setting as components of the program. Short-term goals were discussed. Peer mentors helped mentees with setting small, attainable goals which contributed to a larger, overall goal. One peer mentor also described realizing his own shortcomings in being more involved in the community and volunteering through conversations with his mentee and set his own goals to be more involved. Social influences Mentees and peer mentors both reported social support as an outcome; social support arose as the most dominant theme of the interviews. Reinforcement and validation were reported through the mutual sharing of similar experiences. Social support was a topic of conversation (i.e., discussion around family and romantic relationships). | Contradiction between quantitative and qualitative findings For a relatively short-term study (i.e., data collection in the current study was constricted to a four-month timeframe compared to the regular OBIA Peer Support Program which can last up to a year), community integration may not be a feasible outcome to measure and/or improve for partners. Connecting to and volunteering within the community were both topics which were infrequently discussed by mentees. However, progress in other areas, including knowledge, skills, goals, and social support suggest that it is conceivable that the short-term benefits of peer support occur on an individual, rather than community level. While community integration may be too distal an outcome to achieve within a four-month timeline, several of the qualitative outcomes described by mentees correspond to subscales of the CIQ and may represent specific mechanisms by which community integration can occur. Hearing about a peer mentor’s successes in raising children, returning to work, or maintaining relationships with family and friends may inspire increased awareness and confidence and elicit individual benefits for mentees in specific domains. |
Mood | No statistically significant change PHQ-9: mean score increased from 14.2 (7.25) to 18.8 (8.96) for the intervention group and from 13.3 (7.09) to 13.7 (8.96) for the control group after two months. Mean score decreased to 10.4 (5.72) for the intervention group and to 13.0 (5.89) for the control group after four months (g = 0.447; CI = −0.715–1.608) Note: a higher PHQ-9 score is indicative of a higher level of depression severity | Optimism Mentees identified optimism as an outcome or intended outcome of the program. Mentees derived hope and inspiration from their mentors for progressing through their recovery. Emotion Positive and negative emotions were experienced by both mentees and peer mentors. Positive affect was described as generally feeling better after speaking with someone. Negative affect was described as an outcome for both partners and mentors if the topic of a conversation was particularly depressing or negative. Peer mentors experienced negative affect due to difficult conversations and emotional investment in their partner or feelings of unfulfillment due to an unsuitable match. | Some complementarity and some contradiction between quantitative and qualitative findings Recognizing the cyclical nature of mood (and of the interactions between mentees and peer mentors) is important to the synthesis of the mood-related findings. The nature of the discussions between mentees and peer mentors, particularly early on in the program, may have been a key factor in mediating the initial increases in depression severity for both the intervention and control groups after two months, as well as the negative emotions experienced by mentees. Discussion of more burdensome topics and/or difficult issues (e.g., the brain injury itself) at the start of the program may be expected due to mentees’ and peer mentors’ desires to address acute or critical issues as soon as possible (i.e., before broadening the conversations to other topics). While such conversations can serve an exploratory role and help form a strong connection early on so that mentees and peer mentors can easily build rapport, they may also elicit negative emotions in some cases (e.g., due to compassion fatigue by peer mentors). It is conceivable that as discussions progress to other topics of interest, such as hobbies or relationships, conversations occurring later in the program may ultimately elicit more positive emotions. Further exploration of this trend (i.e., after four months) is warranted given the individual variances which can occur in mood and the small sample size used in our study. The cyclical nature of mood also underscores the importance of finding appropriate mentee–peer mentor matches so that conversations continue to remain engaging and deliver hope and inspiration to mentees, thereby promoting positive emotions for the duration of the program. |
Health-related quality of life | SF-20: statistically significant lower mean “pain” health concept score for the intervention group compared to the control group at two months (p = 0.021; g = 0.187; CI = −0.915–1.28) SF-20: statistically significant increase in mean “role functioning” health concept score for the intervention and control groups after four months (p = 0.05), but no difference between groups (i.e., interaction) was observed No other statistically significant changes | Knowledge Mentees and peeer mentors received and shared tips on strategies around symptom management (e.g., memory, organization), medications, and pain management. Skills Mentees and peer mentors both experienced skill development due to the sharing of knowledge on multiple issues, including organization (e.g., using calendars and calendar reminders) and returning to work. Emotion Positive and negative emotions were experienced by both mentees and peer mentors. Positive affect was described as generally feeling better after speaking with someone. Negative affect was described as an outcome for both mentees and peer mentors if the topic of a conversation was particularly depressing or negative. Beliefs about capabilities Mentees felt more confident in their decisions and the ways they have done things due to validation from peer mentors. Mentees and peer mentors experienced greater perceived competence and self-efficacy and felt more empowered. | Some complementarity between quantitative and qualitative findings Peer support programs may lead to improvements in pain via the sharing of knowledge on pain management techniques. Focused discussions on concrete strategies to employ for pain management (e.g., use of physical aids, medications, and/or meditation) may help develop mentees’ awareness and contribute to the exploration and use of additional, potentially helpful approaches by mentees. While SF-20 scores did not increase after four months for all health concepts, it is conceivable from our qualitative results that improvements in knowledge, skills, positive emotion, and beliefs about capabilities may all act as mechanisms of action for enhancing health-related quality of life. Discussions on daily activities and/or returning to work may have served to improve knowledge and skills to help with role functioning; however, since the control group also experienced a significant increase in role functioning after four months, it is conceivable that this health concept is one which naturally improves over time in patients as part of typical recovery progression. Beliefs about capabilities may also act as mediators to some SF-20 health concepts depending on factors such as a mentee’s individual emotions or mindset during peer support. |
Self-efficacy | No statistically significant change TBI-SE: total mean score decreased from 75 (38.18) to 68.7 (28.55) for the intervention group and increased from 82.1 (30.73) to 83.3 (21.55) for the control group after four months (g = 0.585; CI = −0.529–1.698) TBI-SE: greater decrease in mean “social and community” subscale score for the intervention group compared to the control group after four months (trend toward significance; p = 0.063) | Knowledge Peer mentors shared knowledge of approaches or strategies that have previously worked for them (e.g., resource knowledge sharing) but respected professional boundaries by limiting their provision of specific advice to mentees. Skills Various skills (e.g., dealing with exhaustion and memory issues) were discussed as topics of conversation. Development of interpersonal skills was described as an outcome of participating in peer support by both mentees and peer mentors. Socializing through the program led to enhanced phone skills, including increased comfort and ease of speaking with someone else. Peer mentors reported improvements in mentor-related skills, including listening, selflessness, and having difficult conversations. Beliefs about capabilities Self-confidence, perceived competence, self-efficacy, and empowerment were experienced by both mentees and peer mentors. Mentees reported feeling more confident in their actions and decisions following validation from mentors. Improved self-esteem was also noted as an outcome by one mentee. Reinforcement Reinforcement was used as a strategy by peer mentors during conversations for partners’ actions or for the goals which mentees had set. | Contradiction between quantitative and qualitative findings While TBI-SE scores decreased for the intervention group after four months, our qualitative findings indicate that vicarious experience may help to promote mentees’ knowledge and skills, which may both serve as vehicles for ultimate improvement of self-efficacy. However, although hearing peer mentors’ success stories is conceivably advantageous and encouraging for mentees, it is also possible that such discussions may be overwhelming or even demotivating in some cases. Mentees may feel discouraged if discussions reveal significant gaps between their current situation/progression in recovery, compared to that of their peer mentor. This situation may be especially pertinent for mentees in an early stage of recovery or at the beginning of the peer support program. It is conceivable that mentees’ receptions to such discussions and consequent changes in self-efficacy may be mediated in part by factors such as emotions or mood (e.g., if a mentee feels optimistic or pessimistic while discussing his or her peer mentor’s successes). |
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Levy, B.B.; Luong, D.; Bayley, M.T.; Sweet, S.N.; Voth, J.; Kastner, M.; Nelson, M.L.A.; Jaglal, S.B.; Salbach, N.M.; Wilcock, R.; et al. A Pilot Feasibility Randomized Controlled Trial on the Ontario Brain Injury Association Peer Support Program. J. Clin. Med. 2021, 10, 2913. https://doi.org/10.3390/jcm10132913
Levy BB, Luong D, Bayley MT, Sweet SN, Voth J, Kastner M, Nelson MLA, Jaglal SB, Salbach NM, Wilcock R, et al. A Pilot Feasibility Randomized Controlled Trial on the Ontario Brain Injury Association Peer Support Program. Journal of Clinical Medicine. 2021; 10(13):2913. https://doi.org/10.3390/jcm10132913
Chicago/Turabian StyleLevy, Ben B., Dorothy Luong, Mark T. Bayley, Shane N. Sweet, Jennifer Voth, Monika Kastner, Michelle L. A. Nelson, Susan B. Jaglal, Nancy M. Salbach, Ruth Wilcock, and et al. 2021. "A Pilot Feasibility Randomized Controlled Trial on the Ontario Brain Injury Association Peer Support Program" Journal of Clinical Medicine 10, no. 13: 2913. https://doi.org/10.3390/jcm10132913
APA StyleLevy, B. B., Luong, D., Bayley, M. T., Sweet, S. N., Voth, J., Kastner, M., Nelson, M. L. A., Jaglal, S. B., Salbach, N. M., Wilcock, R., Thoms, C., Shepherd, J., & Munce, S. E. P. (2021). A Pilot Feasibility Randomized Controlled Trial on the Ontario Brain Injury Association Peer Support Program. Journal of Clinical Medicine, 10(13), 2913. https://doi.org/10.3390/jcm10132913