Effectiveness of a Customized Digital Platform to Increase Coordination of Care and Uptake of Evidence-based Practices

NCT06867081 | Not Yet Recruiting

• 2 other identifiers: 2024-58314481022
• Study Type: interventional
• Target: 962
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aquired Brain Injury; Traumatic Brain Injuries; Stroke; Cardiovascular Diseases

Keywords

Acquired brain injury; Digital health platform; Rehabilitation; Transition of care; Person-centered care; Implementation science; stepped wedge trial

Outcome Measures

Primary Outcomes (1)

• 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.

  27 months

Secondary Outcomes (7)

• Time to be admitted to rehabilitation (inpatient or outpatient)

  12 months

• Health-related quality of life

  27 months

• Care experience, and perceived effectiveness

  27 months

• Sex and gender identification

  27 months

• Satisfaction with the BRILLIANT Platform

  12 months

Study Arms (8)

Rehabilitation Program 1

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 2

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 3

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 4

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 5

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 6

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 7

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Rehabilitation Program 8

EXPERIMENTAL

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Other: The intervention will be the BRILLIANT Platform, an online platform which provides five Modules aimed at increasing coordination of care and direct rehabilitation time

Interventions

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

The 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.

Rehabilitation Program 1; Rehabilitation Program 2; Rehabilitation Program 3; Rehabilitation Program 4; Rehabilitation Program 5; Rehabilitation Program 6; Rehabilitation Program 7; Rehabilitation Program 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians, coordinators, managers, working in the 8 participating programs.
• Patients and caregivers must be able to:
• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead

Study Sites (2)

CIUSSS du Centre-Sud-de-l'Île-de-Montréal

Montreal, Quebec, H2S 3L5, Canada

Location

Centre de réadaptation Lethbridge-Layton-Mackay, installation Constance-Lethbridge

Montreal, Quebec, H4B 1T3, Canada

Location

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MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Cardiovascular Diseases; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases

Central Study Contacts

Sara Ahmed, PhD

CONTACT

15148021366; sara.ahmed@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will conduct a stepped wedge cluster randomized trial in four health regions and 8 programs (i.e., clusters). A stepped wedge cluster randomized trial is a special case of cluster cross over designs particularly useful in an educational context where clusters (e.g., programs, clinicians) can only change their exposure status (i.e., participation in the intervention) in one direction (i.e., from less knowledgeable, before the intervention, to more knowledgeable, after the intervention). It is an ideal design as programs intend to implement the BRILLIANT platform as an ongoing part of practice. We expect trends over time will be similar across all ABI programs in each region. Identification and recruitment bias is a concern in stepped wedge trials when recruitment occurs after randomization.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: March 10, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CA (2)