Telehealth Transition Assistance Program for Acute Spinal Cord Injury Caregivers: Protocol for a Mixed-Methods, Randomized Controlled Trial

Background While spinal cord injury (SCI) caregiving can be a rewarding experience, caregivers often experience reduced mental and physical health. Objective This article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI. Methods A mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control. The study is recruiting for 48 months and incorporating quantitative outcome measures. Results This study was funded by the Craig H. Neilsen Foundation in April 2017. It was approved by the institutional review boards at Virginia Commonwealth University and the Hunter Holmes McGuire Veterans Affairs Medical Center that same year. Participant recruitment and data collection began in 2018. Conclusions This study is implementing and testing an SCI caregiver intervention unlike any created before, targeting a critical time period that, until now, other SCI caregiver interventions have overlooked. Research personnel intend to disseminate the intervention and study findings through the publication of manuscripts and presentations at conferences. If the current study shows improvements in caregiver or patient well-being, the TAP for SCI caregivers could become part of the standard of care for acute SCI. Trial Registration ClinicalTrials.gov NCT03244098; https://www.clinicaltrials.gov/ct2/show/NCT03244098 International Registered Report Identifier (IRRID) DERR1-10.2196/28256


OVERALL IMPACT
After considering all of the review criteria, summarize the significant strengths and weaknesses of the application. In this funding category, does this project address important gaps or propose cuttingedge ideas, interventions and/or test approaches that have great potential to have a positive impact for those living with SCI? Please state the likelihood that the project scope suits this funding level and will develop an area of work that has the potential to exert a sustained powerful influence on the SCI field and/or be an important contributor to the field of SCI research.
: Strengths of this project include an outstanding team of investigators with vast experience in caregiver interventions, previous experience with telehealth modalities and a sound research design. The rationale for the study is well supported by the existing literature and addresses a significant gap in caregiver support the transition from rehab to home. Few and relatively insignificant weaknesses include some of the outcome measures selected and a possibly inadequate sample overrecruitment is probably warranted to ensure complete data on 44 dyads. This project, if successful will lead to seeking further funding to expand this program to other sites and develop a standardized rehabilitation protocol utilizing the TAP program. SIGNIFICANCE 1. Does the project address an important problem or a critical barrier in the field? 2. If the Aims of the project are achieved, how would this work change or enhance current methods, technologies, treatments, services, or interventions? : Caregivers are often thrown into "real life" with little training and have to face difficulties at home that may not have been anticipated during rehabilitation. Preparing caregivers with as many skills as possible prior to return home with their family members is critical to the overall wellbeing and health of both the caregiver and care recipient. This study addresses a gap that currently exists and addresses the transition to home using a telehealth Transition Assistance Program (TAP) to determine if such an intervention can minimize depression, improve relationship satisfaction, selfefficacy, health status and well being among informal caregivers. Existing programs for people with stroke have been relatively effective and the investigators (who conducted the stroke study) are modifying this intervention to caregivers of people with SCI. The features of this program, if successful, could be implemented relatively easily and at low cost in other settings and could lead to better caregiver and care recipient outcomes for those engaging in TAP. The project is highly relevant to the CHNF mission to improve quality of life for people with SCI and with the PSR portfolio goals in that it explores a previously tested (and to be modified) intervention to assist caregivers in better managing their caregiving role and responsibilities. Better caregiver outcomes have been demonstrated to relate to better care recipient outcomes.
INVESTIGATOR(S) 1. Are the PI, collaborators, and other contributors well suited to the project? 2. If the PI is a junior investigator, does he/she have appropriate experience, training and facilities to do the proposed work? If the PI is an established investigator, has he/she demonstrated an ongoing record of accomplishments that have advanced their field(s)? : The team of investigators is extremely well suited to carry out this project. Dr. Perrin, although relatively early in his career, has focused on developing caregiver interventions. Dr. Elliott is one of the top names in caregiver research in SCI and has been instrumental in developing cognitive behavioral interventions for caregivers. He has published widely in this area. Dr. McDonald brings the focus to veterans and although most of his work has related to brain injury ,he will provide useful collaboration from the VA. Dr. Pickett has utilized telehealth methodology in his career with other disability populations. In all, this team is excellent in composition to carry out the specific intervention, analysis and dissemination of the study findings. INNOVATION 1. Does the project challenge and seek to shift current research or clinical practice/program intervention paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? https://proposalcentral.altum.com/ShowReviewInfo.asp?ProposalID=439128&token1=%EF%BF%BD%EF%BF%BD%EF%BF%BD%EF%BF%BD%EF… 2/4 3. And/or is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? : The proposed TAP project is innovative, not in the methodology itself, but in the timing of the intervention. By addressing issues with caregivers during rehab and as they transition home. Other identified interventions have not been targeting this critical time period. The use of the telehealth component after caregivers have left the rehab setting eliminates geographical barriers and provides continuity of intervention with the same therapist conducting the followup. The investigators did an excellent job of homework by identifying existing funded caregiver projects from the CHNF and highlighting that although they each have potential benefits, none address the critical transition period that the current study addresses. The experience of the investigators in delivering interventions to caregivers strengthens the project considerably, and the fact that this intervention has been used in other populations is promising. APPROACH 1. Are the overall strategy, methodology, and analyses wellreasoned and appropriate to accomplish the specific aims of the project, within the proposed project period and by the project team described? Are potential problems, alternative strategies, and benchmarks for success presented? 2. Are preliminary data provided to support the feasibility of the project? Or, if the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed adequately?
3. If the project involves clinical and/or communitybased research: A) are the plans for protection of human subjects from research risks described and adequate; and B) are the plans for recruitment of patients/participants appropriate? : Many of the citations supporting the project are rather dated (other than those from the investigators themselves). Nonetheless, this is an important topic and the approach to study the issue is appropriate and well designed. Strengths are having strong preliminary data from the stroke study and the ability to modify that program reduces start up and operational costs. Of some concern is that the developed guidebook will be evaluated by clinicians but it seems that evaluation by caregivers themselves would be critical. Not sure why FIM is being used it is problematic in general and while widely used and validated in SCI (and for telephone administration) it may not be the best tool consider SCIM? The ECS rating of quality of care has only been used in older adults and while it is suggested that it is applicable to other populations, this has not been validated. Is the walk/wheelchair version of the SF12 being used? It is more relevant to this population. The recruitment and enrollment plan does not seem to account for attrition. Even though the intervention is relatively short, there is likely to be dropout, particularly in the control group. Human subjects protections are well described and appropriate. The table outlining challenges and how they will be addressed is excellent. ENVIRONMENT 1. Will the institutional environment in which the work will be done contribute to the probability of success?
2. Are the institutional support, physical equipment and other resources available to the investigators adequate for the project proposed?
3. Will the project benefit from unique features of their environment, subject populations, or collaborative arrangements? : The environment is entirely appropriate for the study activities. There is support from the VA to use space for the study. Telehealth capabilities are in place.  (237821) OVERALL IMPACT After considering all of the review criteria, summarize the significant strengths and weaknesses of the application. In this funding category, does this project address important gaps or propose cuttingedge ideas, interventions and/or test approaches that have great potential to have a positive impact for those living with SCI? Please state the likelihood that the project scope suits this funding level and will develop an area of work that has the potential to exert a sustained powerful influence on the SCI field and/or be an important contributor to the field of SCI research.

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The proposed study addresses an important problem, caregiver burden and distress by modifying an intervention that was successful with stroke caregivers and applying it to SCI caregivers. The applicant anticipates potential problems and lists strategies to mitigate study risk. The randomized controlled design is a strength; the telehealth delivery is apt to be cost effective and reproducible. The project scope suits this funding level and is highly likely to develop an area of work that has the potential to exert a sustained powerful influence on the SCI field. SIGNIFICANCE 1. Does the project address an important problem or a critical barrier in the field? 2. If the Aims of the project are achieved, how would this work change or enhance current methods, technologies, treatments, services, or interventions?
: This application addresses an important problem in SCI rehabilitation, caregiver distress. Many SCI and caregivers experience longterm distress related to postSCI functional changes that makes postSCI social and community reintegration challenging. Many caregivers are significantly distressed during the first year of caregiving for a person with SCI. They experience strain, depression, and anxiety, as well as limited time for rest and lower general health. They often feel hopeless and trapped within their circumstances. Often SCI caregivers experience inadequate support and response to their needs from others in their social network during the transition home. Given these needs, little research on interventions for SCI caregivers has been reported. If the Aims of the project are achieved, development and initial evaluation of caregiver intervention would lead to enhanced interventions for caregivers. RELEVANCE 1. How is this project relevant to the mission of the Neilsen Foundation?