Effectiveness of a Customized Digital Platform to Increase Coordination of Care and Uptake of Evidence-based Practices: a Protocol for a Stepped-wedge Cluster Randomized Trial in Quebec
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 962
- 试验地点
- 4
- 主要终点
- The intensity of rehabilitation
研究概览
简要总结
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.
详细描述
Research questions and sites The research questions guiding this study are: 1) What are the potential barriers and facilitators in the implementation of the BRILLIANT platform at the local teams' level?; 2) What is the impact of the BRILLIANT platform compared to usual cardiovascular and neurological care on the primary outcome, intensity of rehabilitation (direct minutes of rehabilitation per week); 3) Does the platform have an impact on secondary outcomes: time to be admitted to rehabilitation (inpatient or outpatient), health-related quality of life, care experience, and if found to be effective, costs?; 4) What are the implementation factors that explain potential impact (e.g., relevance, acceptability)? An integrated knowledge translation (iKT) approach will be used by involving all relevant partners throughout the research process. The partners are stakeholders within four health regions with two to four programs each in various rehabilitation stages for cardiovascular and neurological care in Quebec. In four health regions and 8 cardiovascular and neurological programs, this implementation study follows two phases aiming answering the 4 research questions.
Study phases and procedures Phase I is for measuring and addressing the potential barriers and facilitators related to the implementation of the BRILLIANT platform and prepare teams for implementation. With each program investigators will review the workflow (clinical processes and the material and human resources available) for cardiovascular and neurological care pathways, and use the Business Process Model and Notation (BPMN) method and analyze them to maximize successful implementation during the trial. The purpose of this first phase is to determine what the BRILLIANT platform will look like. Through focus groups with 8-10 participants per program comprised of all health professions, coordinators, managers, and patient/family participants with experience with different phases of the rehabilitation process. In the focus groups, investigators will review how the platform will work, validate certain tasks, and ensure ease of use so that investigators may adjust as needed. Identifying barriers and facilitators to implementing the platform during the focus groups will be guided by the Consolidated Framework for Implementation Research (CFIR). Focus group sessions will be recorded and transcribed, and further analysed to feed back information on barriers and facilitators during subsequent design workshops to also inform adaptation and implementation of the platform.
The second phase is to evaluate the impact of the BRILLIANT platform on primary (intensity of rehabilitation, i.e. direct minutes of rehabilitation per week), and secondary outcomes (time to be admitted to inpatient or outpatient rehabilitation, health-related quality of life, care experience, and costs if the platform is found to have an impact) and evaluating the factors that impact implementation. The control condition will be usual care, which consists of an interdisciplinary team of physiotherapy, occupational therapy, nursing, medicine, psychology, speech therapy, social work, and nutrition. Clinicians mostly work on paper evaluating patient needs (mostly by checklist) using static standardized forms (e.g., Functional Independence Measure, FIM, at admission) without reminders, scoring and interactive functionalities. The choice of standardized assessment is left to the discretion of each clinician. Since the pandemic Microsoft teams is used to share scanned documents between clinicians and remote program meetings. During the control period clinicians will have access to static forms on the BRILLIANT Platform.
Intervention details The intervention will be the use of the BRILLIANT Platform. The platform provides five Modules aimed at increasing coordination of care and direct rehabilitation time (Table 1): 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 (e.g. FIM, Mayo Portland Adaptability Inventory - MPAI), performance based outcomes (e.g. gait speed), patient reported outcome measures (e.g. pain level during walking); 2) Communication Module: clinicians can communicate together and with patient/family to clarify patient-related information (e.g. safety concerns, intervention plan progression) and update colleagues for time sensitive information, synchronously (scheduled tele-videoconference) 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 (e.g. treadmill walking practice) at the right time based on clinical and social profile and best practices;1,2 4) Self-management support: To provide patients and families with self-management dashboards (e.g. physical activity tracking and reminders) and interactive online intervention plan (goals, action plan, monitoring progress) to actively engage the patient and family in setting goals with their care team. Access to evidence-based patient education and resource modules, tailored to stage of recovery (e.g. Education on how to handle arm or shoulder); 5) Quality Improvement Dashboards to provide feedback and reports allowing observation of clinical/administrative/clinical performance indicators (based on MSSS indicators, Quadruple Aim framework) for continuous program evaluation.
Each health region will be provided with cloud-based access to the platform as agreed in collaboration with their IT units. Each site will have support from a knowledge broker from the research team to promote the platform's purpose, features and benefits and build understanding, and engagement of the local programs. Pre-implementation, there will be: 1) a 2-hour training session (respecting COVID restrictions) in each site and an online training video that participants can access anytime; 2) a platform guidebook explaining each functionality, that can be accessed anytime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
The intensity of rehabilitation
时间窗: 27 months
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.
次要结局
- 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)
- 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)
- Economic evaluation - cost-utility analysis(27 months)
- Economic evaluation - cost-effectiveness(27 months)
研究者
Sara Ahmed
Principal Investigator
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
