Feasibility of a Community-Based, Online, Peer-Supported Spinal Cord Injury Self-management Intervention: Protocol for a Pilot Wait-Listed Randomized Trial

Background People with spinal cord injury (SCI) report feeling unprepared to manage their disability upon discharge to the community. This situation is exacerbated when they return to settings where self-management support and resources are sparse, thus increasing the risk of costly secondary conditions and rehospitalizations. These factors make a compelling case for implementing innovative community-based SCI self-management programs that empower and engage individuals with SCI. Using a community-engaged research (CEnR) approach, we developed a peer-supported SCI self-management intervention, known as PHOENIX (Peer-supported Health Outreach, Education, and Information Exchange), which integrates online educational content and support from peer navigators (PNs) through telehealth, to promote health and community participation after SCI. Objective The objective of this pilot study is to evaluate the feasibility and acceptability of PHOENIX and the study design, and to obtain estimates of the variability of relevant outcome measures. Methods We conducted a pilot randomized waitlist-controlled trial (n=30) in collaboration with the South Carolina Spinal Cord Injury Association (SCSCIA), our long-standing community-based nonprofit organization research partner. We recruited 4 PNs through our SCSCIA collaboration using its existing network of trained peer mentors. Our study design supported comparison of the following 2 randomly assigned groups: PHOENIX intervention group and waitlist enhanced usual care (EUC) group. The PHOENIX intervention was administered online by PNs over 16 weeks through scheduled “video visits.” The EUC group participated in the study for 16 weeks with usual community services and no navigation, and received 4 monthly newsletters from the SCSCIA on a variety of SCI-relevant topics. At the end of the waitlist period, the waitlist EUC group received the full PHOENIX intervention. Measures of feasibility included PN and participant recruitment and retention, PN workload, protocol adherence, and incidence of technical issues. We conducted qualitative interviews with participants and PNs to evaluate the acceptability of PHOENIX and the study design. Outcome measures, including community participation, quality of life, and the occurrence and subjective impact of medically serious secondary conditions and rehospitalizations, were assessed at baseline after randomization and at subsequent time points to allow between-group comparisons. Results PN hiring and training were completed in August 2018. Recruitment began in November 2018. A total of 30 participants were recruited across South Carolina, and 28 participants completed follow-up by August 2020. An analysis of the results is being finalized, and the results are expected to be published in 2023. Conclusions This study will provide valuable information to guide future research seeking to address unmet self-management needs and improve outcomes in individuals with SCI. Feasibility findings of this study will provide evidence from CEnR guided by people with SCI and SCI service providers to inform further development, testing, and dissemination of effective and scalable self-management strategies for people with SCI. International Registered Report Identifier (IRRID) RR1-10.2196/42688

While all panel members noted multiple strengths in the Design of Research Activities section, several panel members mentioned weaknesses. Most of these were related to the Phase II study; equivalence of the treatment and control group, how treatment dropouts will be handled, and how the treatment materials will be developed. Specific concerns are listed here: Treatment assignment will not be stratified by time since injury, or by injury level.
There is no clarity on what constitutes the completion of the study by a participant and how dropouts will be treated.
For people with a longer time from injury, the value of the strategies they have already developed is not discussed.
There seems to be very little details/description on the method to produce the videos and the potential barriers. It was unclear if the applicant recognizes the complicated nature of creating meaningful videos and has access to individuals or companies who have the expertise to do so.
One reviewer expected additional methods of providing feedback (such as focus groups). One reviewer noted that equal opportunity does not equate to actively recruiting underrepresented groups.
Computer access and transportation access details were not clear. Resources for development of the multimedia materials in alternate sources was not addressed.
Panel reviewers displayed different expectations for what was required regarding the accessibility of resources. Some felt the information presented was sufficient, while others were looking for additional details for the accessibility of materials, technology and dissemination.

Weakness:
Page: 48-50 The applicant does not list access to a media company in their resource section. Given the complexity of creating videos to teach skills and engage the learner, it seems that access to this expertise is needed. In addition accessibility should include accessibility of project materials and outputs as opposed to just accommodations that will be made.

Page: resources
The applicant provides only limited information about access to technology resources and support to convert program to info into a web format would be useful Page: 1-9 The target population is well described. The importance of the problem is very well documented and shows a profound and wide ranging appreciation of the problem of self-management service models for people with SCI. The relationship to the act is good. The impact of peer-supported self management and telehealth has been provided adequately.

Weakness:
Page: 1-9 The impact of peer-supported self management and telehealth has been provided in terms of possibly better interventions with activities of quality of life even if more details could be provided such as financial savings, measures of performance, etc.

Criterion 2: Design of research activities Strength:
Page: 10-40 The research hypothesis concept is sound and there is no doubt about the importance of the proposed selfmanagement and teleheath system for the overall quality of life of the targeted beneficiaries. Thus, the concept is described and illustrated effectively while the participating population is of sufficient size. The data analysis and collection methods are appropriate while the input of individuals with disabilities is used to shape the proposed research activities. The applicant identifies and justifies the stage of research being proposed and the research methods associated with the stage.

Strength:
Page: 40-42 The appropriateness of monitoring and evaluation methods (e.g. meetings) have been demonstrated with sufficient precision for the proposed project cycle by following the agile methodology.

Weakness:
Page: 40-42 More details and more methods/protocols (e.g. focus groups) could be provided for the evaluation and the quality of the proposed work. Additionally, the method of providing feedback to the project staff as the project proceeded was not clear. Page: 1-9 This part has been very well written. Need and target populations are very well described. All important aspects have been covered. The use of peer mentors is a good idea. Use of a person with similar conditions can help. The study definitely furthers purposes of the act by generating new scientific knowledge on communitybased self-management interventions that are designed to optimize the health, independence, community participation, and QOL of individuals with SCI. At the end of the study, the outcome will be improved QOL after SCI by increasing self-management capacity leading to an increase in community participation and prevention of medically serious secondary conditions.

None
Criterion 2: Design of research activities Strength:

Weakness:
Page: 9-40 Too much information from the previous study actually creates a few obstacles in the reading of this section, throughout the application. The inclusion criteria is very broad especially with respect to time since injury (p.30). People with an injury for many years have developed strategies to address some of their problems. So it is not clear what exact purpose the video will be serving. Qualitative data analysis needs to be better defined. it is unclear as to which approach is being used for the qualitative data analysis.