About this trial
Background: Cardiovascular and neurological conditions are major causes of disability worldwide. Early, intensive rehabilitation is essential but often challenging to access in current healthcare systems. In Canada, the direct and indirect costs of acquired brain injury (ABI) are substantial, emphasizing the need for improved rehabilitation services. In collaboration with four health regions and the Canadian Foundation of Innovation (CFI) funded BRILLIANT research group, investigators are implementing a digital health platform (the BRILLIANT platform), which includes five modules to address current gaps and support a person-centered integrated care continuum for cardiovascular and neurological conditions. In this stepped wedge randomized trial, investigators plan to implement and evaluate the use of the BRILLIANT Platform for improving transitions of care in the rehabilitation of ABI individuals in Quebec.
Methods: A stepped wedge cluster randomized trial will be conducted across four healthcare regions with eight programs. Eligible participants included new cardiovascular and neurological patients, caregivers, clinicians, coordinators, and managers. The BRILLIANT platform intervention, implemented in 2 phases, will provide standardized assessments, communication tools, shared intervention plans, self-management support, and quality improvement dashboards. Outcomes will include rehabilitation intensity measured in minutes, time from admission to rehabilitation, health-related quality of life, care experience, and costs. Data analysis will use mixed-effects models for quantitative data and content analysis for qualitative data.
Discussion: This study will provide valuable evidence on the effectiveness and feasibility of the BRILLIANT platform in improving rehabilitation care for patients with cardiovascular and neurological conditions in Quebec. Investigators anticipate that by addressing the challenges and pursuing future directions, the implementation of this digital platform can contribute to improving patient outcomes and healthcare delivery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide informed consent to collect secondary outcomes (not needed for primary outcome, as identified administrative data will be provided by health regions)
Speak and read English or French.
Disqualifiers
N/A
Trial design
Crossover
Treatments tested in this trial
The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time
Other interventionThe BRILLIANT Platform provides five Modules aimed at increasing coordination of care and direct rehabilitation time: 1) Standardized measures: provided consistently with scoring and reminders to complete assessments, across all stages of recovery and care settings to guide and evaluate treatment effectiveness of clinical outcomes, performance based outcomes, patient reported outcome measures; 2) Communication Module: clinicians can communicate together and with patient/family to clarify patient-related information and update colleagues for time sensitive information, synchronously and asynchronously; 3) Shared intervention goals and plan: personalized and dynamic care trajectory and intervention plan guided by standardized assessments, reminders, and evidence-based interventions recommendations to direct patients and caregivers to the right services and interventions at the right time based on clinical and social profile and best practices; and 2 other related topics.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
The intensity of rehabilitation
The intensity of rehabilitation (direct minutes of rehabilitation per week) will be calculated for all new patients seen during the control and intervention period using data from SIPAD64 (Système d'information pour les personnes ayant une déficience), that will be obtained from the directorate of professional services (DPS) administrative database where clinicians record the direct and indirect time spent with patients and caregivers.
Secondary outcomes
Time to be admitted to rehabilitation (inpatient or outpatient)
The time from cardiovascular or neurological condition onset to inpatient or home rehabilitation admission data will be obtained from SIPAD, similar to the primary outcome.
Health-related quality of life
Data from patients will be collected using the Quality of Life in Neurological Disorders (Neuro-QoL) battery of measures and the EuroQol 5-Dimension, 5-Level (EQ-5D-5L). The EQ-5D-5L index score ranges from -0.281 to 1.000, with higher scores indicating "full health-related quality of life". The Neuro-QoL instruments each yield standardized T-scores ranging from 10 to 90 (mean 50, SD 10 in the reference population), where higher scores indicate more of the concept being measured. Caregivers' health-related quality of life will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile, which produces domain scores standardized to a T-score metric (mean 50), ranging from 20 to 80. Higher scores reflect more of the domain, with better outcomes for positive domains and worse outcomes for negative domains.
Care experience, and perceived effectiveness
Caregiver burden will be measured with the Bakas Caregiving Outcomes Scale (15 items, scores 15 - 105; in which higher scores represent more negative change in well-being). Patient experience will be assessed using the Patient Participation in Rehabilitation Questionnaire (scores 0 - 100; in which higher scores represent greater participation). Clinicians' experience implementing BRILLIANT will be measured using the Normalization Measure Development (NoMAD, scores 20 - 100; in which higher scores represent greater normalization of practice change).
Sex and gender identification
Sex and gender identification will be collected using two self-identified items.
Sponsors and contacts
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