Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial

Background Strong evidence supports beginning stroke rehabilitation as soon as the patient’s medical status has stabilized and continuing following discharge from acute care. However, adherence to rehabilitation treatments over the rehabilitation phase has been shown to be suboptimal. Objective The aim of this study is to assess the impact of a telerehabilitation platform on stroke patients’ adherence to a rehabilitation plan and on their level of reintegration into normal social activities, in comparison with usual care. The primary outcome is patient adherence to stroke rehabilitation (up to 12 weeks), which is hypothesized to influence reintegration into normal living. Secondary outcomes for patients include functional recovery and independence, depression, adverse events related to telerehabilitation, use of services (up to 6 months), perception of interprofessional shared decision making, and quality of services received. Interprofessional collaboration as well as quality of interprofessional shared decision making will be measured with clinicians. Methods In this interrupted time series with a convergent qualitative component, rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to deliver the treatment. The intervention will be comprised of 220 patients who will take part in stroke telerehabilitation with an interdisciplinary group of clinicians (telerehabilitation group) versus face-to-face standard of care (control group: n=110 patients). Results Our Research Ethics Board approved the study in June 2020. Data collection for the control group is underway, with another year planned before we begin the intervention phase. Conclusions This study will contribute to the minimization of both knowledge and practice gaps, while producing robust, in-depth data on the factors related to the effectiveness of telerehabilitation in a stroke rehabilitation continuum. Findings will inform best practice guidelines regarding telecare services and the provision of telerehabilitation, including recommendations for effective interdisciplinary collaboration regarding stroke rehabilitation. Trial Registration ClinicalTrials.gov NCT04440215; https://clinicaltrials.gov/ct2/show/NCT04440215 International Registered Report Identifier (IRRID) DERR1-10.2196/32134

Aujourd'hui, l'activité scientifique est surveillée de près et il est plus important que jamais de veiller à ce que notre travail soit bien compris. Je vous demande donc de faire mention du financement des IRSC dans vos présentations et vos communications au sujet de vos recherches, et de continuer de faire valoir l'importance cruciale de la recherche pour la santé des Canadiennes et des Canadiens.
Encore une fois, je tiens à vous féliciter de cet exploit et à vous offrir mes meilleurs voeux de succès dans toutes vos entreprises. Je suivrai avec intérêt l'avancement de vos recherches. This is a third re-submission for this proposal. This study is a pragmatic clinic trial using an interrupted time series design.
The team aims to enrol 296 patients at a time when they are ready to be discharged from the hospital after a stroke, and their family caregivers. Half of the patients will receive rehabilitation through remote, live treatment sessions with an interdisciplinary team (telerehabilitation). The interdisciplinary team will hold regular meeting and provide a treatment plan that is jointly developed with the patient. The other half will receive the standard care, which has no telerehabilitation, no routine interdisciplinary team meeting, and may not receive an inter-professional care plan (expecting fewer than 2/3 will receive this).
Five rehabilitation sites will participate in this study. They will provide the standard care to approximately 40 patients (recruitment 12 -18 months). Then they will receive training on the telerehab platform to engage the patient/family, on shared decision making, and on how to develop rehabilitation treatment plans that engage the patient and family.
The study's primary objective is to evaluate the process, clinical and economic outcomes of telerehabilitation in comparison with usual care. Their secondary objective is to explore and describe contextual factors (both personal and environmental) that will help the delivery of stroke rehabilitation. At the end of the 12-week telerehab intervention, a subset of participants will be purposively selected for an in-depth interview about their experiences with the program.
This team received a CIHR bridge grant in 2016 to test a telerehabilitation platform at two facilities. This application has been developed by an interdisciplinary team of researchers, local healthcare providers from each region involved, two patient partners who have experienced stroke, provincial network stakeholders, and decision makers, all engaged in the successful implementation of stroke guidelines and jurisdictional strategic plans. They also have a panel of health system knowledge users to enhance knowledge translation, starting in Quebec and Alberta. The study has been endorsed by the Quebec Ministry of Health, and the Quebec Heart and Stroke Foundation. Optimizing patient adherence to stroke rehabilitation treatment: a telerehabilitation trial

Strengths
The proposal is well written with great attention to details. The team has done a stellar job in addressing the previous reviewers' concerns.
This is a strong team with complementary experience. NPA Gaboury was trained in biostatistics, with over 13 years of experience in conducting research with a mixed quantitative-qualitative design. She has published 52 papers in the last 7 years; many of which are related to health service delivery. Co-PI Tousignant held a research chair in telerehabilitation. The team also includes two patient representatives, and a number of experts in stroke rehabilitation and shared decision making.
The conceptual framework on human factors for the telerehab program design is sound. The team takes into consideration the influence of patient impairment, treatment space, training and technology in the intervention design. They pilot study has demonstrated acceptability and feasibility for implementing the program, as well as preliminary efficacy in quality of life.
The study was co-designed with stakeholders, including patients. The primary outcome was identified by patients and health professionals at the pilot as the most meaningful for assessing effectiveness of tele-rehabilitation.
The integrated KT plan is well-articulated. Appropriate knowledge users, including representatives from Quebec Ministry of Health and Alberta Health Services are involved in the study; the collaborations hold great promises for scaling-up in the future.

Weaknesses
The primary outcome is patients' adherence to their stroke rehabilitation plan during the 12 week period. This is operationalized as the time spent doing any stroke rehabilitation exercise. For the intervention period, there is a detailed plan for collecting information about their exercise adherence, such as recording the online sessions, health professional documentations, and journaling by patients. The process for collecting this information is less well defined, however, for patients treated during the control period. Notably, it is expected less than two-thirds of the patients during that period will receive an inter-professional care plan. Since the care during the control period is less cohesive, this may affect patient's self-reporting. Hence, if low exercise participation is found during the control period compared to the intervention period, it would be difficult to discern if it is due to the rehab service delivery, or due to poor reporting by patients during the control period.
Informal caregiver will be recruited to document their experience of care during the intervention period. It is unclear if this will also be done during the control period.   Since the pilot study recruited mostly women, the investigators have explained that they will tailor the recruitment strategy for the RCT to ensure a balance of men and women. Further information about the recruitment strategy would be helpful.
Objective 1 will include a subgroup analysis to examine the effect of sex and gender on rehabilitation (exercise) adherence, as well as a number of clinical and process outcomes. There is a brief mention that gender will be taken into consideration in the qualitative analysis in Objective 2, but no detail is provided. It seems that the team may be missing an opportunity to examine contextual factors through a gender lens from the perspectives of health care providers, patients, and their caregivers. However, these issues are addressable.

Strengths and Weaknesses/Forces et faiblesses:
This pragmatic trial is conducted with knowledge users who are involved throughout providing a compelling iKT approach.
Very well written and compelling rationale. The detail of the methodology is excellent and easy to follow. Feasibility is clear and the tele-rehab platform has been utilised successfully in pilot work. The mixed-methods design is appropriate for the outcomes.
The team have done an excellent job of addressing concerns, and the explanation and detail for the self-report adherence, and not using accelerometry is compelling, particularly given how easy it will be to overwhelm the participants. It is also worth noting that accelerometry can be problematic-missing data, use of cut-points etc. The addition of the scale-up plan is commendable. The potential use of the StREAM tool to assess adherence also strengthens to project.
Strong team -PI has more than 13 years using mixed methods/designing intervention and is joined by a multidisciplinary Evidence supports beginning rehabilitation as soon as the patient's medical status has stabilized. Access, adherence, as well as opportunities for structured interprofessional communication among service providers, and failures to engage the patient and family members in a structured decision making process remain challenges.
The aim of this mixed methods pragmatic clinical trial is to evaluate an intervention that provides patients who have experienced stroke the opportunity to return home safely after their acute hospital stay, to encourage patient/family engagement in the rehabilitation, and to overcome challenges of access to patient-centered interprofessional rehabilitation care.
Interrupted time series design of 148 telerehabilitation rehab vs. standard of care. Primary study objective is to evaluate process, clinical outcomes and costs of telerehabilitation. Second objective is to explore and describe contextual factors that will help the delivery of care, and improve patient's outcomes while fully using technology to deliver stroke rehabilitation care. Optimizing patient adherence to stroke rehabilitation treatment: a telerehabilitation trial