STUDY AIM To evaluate the feasibility and effectiveness of a digital-based short-term post-discharge care program - providing education alone or with additional support - in reducing 30-day unexpected healthcare visits after discharge in low-to-intermediate risk ACS patients in Manitoba, compared to standard care.
STUDY OBJECTIVES Primary Objective: to compare the incidence of 30-day unexpected healthcare visits among low-intermediate risk ACS patients in Manitoba who receive education and support or education alone via a DHT, versus those receiving standard care.
Secondary Objectives: will examine 3 spheres of outcomes, across the 3 study groups:
1. Clinical Outcomes i. To examine and compare the occurrence of major adverse cardiovascular events (MACE) as a composite and individual components, including death, myocardial infarction (MI), repeat revascularization, readmission, stroke, vascular complications, or new HF requiring admission, at 30 days post-discharge ii. To explore the feasibility and acceptability of implementing a digital health platform intervention (DHPI) for extended short-term care for low-intermediate risk ACS patients in Manitoba at 30 days post-discharge iii. To identify patient-specific factors (e.g., home location, age, sex, gender) that may influence the effectiveness of the DHPI on healthcare utilization and recovery outcomes at 30 days post-discharge
2. Psychosocial Outcomes i. To evaluate patient-reported outcomes of mental health (e.g., anxiety, depression), quality of life, and satisfaction with care at 30 days post-discharge ii. To study the impact of the DHPI on patient activation measure, a marker of patients' knowledge, skills and confidence in self-managing their health at 30 days post-discharge iii. To assess patient satisfaction with the DHPI, focusing on usability, accessibility, and overall experience during recovery at 30 days post-discharge
3. Cost i. To conduct a cost-effectiveness analysis comparing the digital health platform interventions (education and support vs education alone) to standard care, examining healthcare resource utilization and potential cost savings at 30 days post-discharge
STUDY DESIGN This study is a single-center, pragmatic randomized controlled trial designed to evaluate post discharge support for low-intermediate risk ACS patients. Before hospital discharge, patients will be screened for eligibility. At discharge, eligible patients will be randomly assigned to one of three groups: (1) standard care; (2) education only and (3) education and support. The pragmatic design ensures that all study procedures-including recruitment, intervention, and follow-up-are closely integrated with routine clinical care, with minimal deviations beyond the study intervention itself. This approach enhances real-world applicability, making it easier to implement findings into everyday clinical practice. Study design and implementation are guided by the PRagmatic Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to ensure clinical relevance and feasibility. Full Research Ethics Board and institutional review board approval will be obtained before the study begins. The study will be registered on ClinicalTrials.gov.
STUDY INTERVENTION Remote Home Monitoring (RHM) is a secure, web-based, digital health application designed to support patients in their recovery. When used to its fullest extent, patients can access tailored education, real-time monitoring, track their health, and connect with care providers. RHM aims to improve patient knowledge, encourage self-management, and provide timely clinical support to reduce unexpected healthcare visits.
Study participants will be randomly assigned to one of three groups: standard care arm (SA), RHM education only arm (EA), RHM full intervention arm with education and support (FA). Before discharge, all patients will be provided with a blood pressure monitor and oximeter, allowing them to track their blood pressure and blood oxygen saturation at home. This not only supports ongoing health monitoring but also empowers patients to take an active role in managing their health.
(A) Standard Care Arm: Patients will receive standard education in hospital. They will not be registered in the RHM application or receive education modules, health care interviews or virtual appointments.
(B) Education Only Arm: Patients will be enrolled in the RHM application, allowing tracking of their access to the education modules. They will start with an introductory module, followed by one module per day for a total of 7 modules covering key topics related to ACS (Cardiac Rehabilitation, Heart Attack Risk Factors, Living with Heart Disease, Medications, Mental Health, Nutrition, Physical Activity). Participants that have atrial fibrillation will receive an additional education module on that topic, and participants with heart failure with receive an additional education module relating to that topic. Engagement for modules will be monitored, if any patient misses more than one module, they will be contacted for a reminder and troubleshooting. Participants will have access to the RHM education modules for 30 days post hospital discharge.
(C) Full Intervention Arm: Patients will be enrolled in the RHM application. Patients will receive all interventions in the EA, and in addition, they will receive support through the RHM application. Patients will complete health care surveys three times a week, covering topics such as symptoms, vital signs, medication side effects, functional status, and whether they have questions or concerns. Patients will have three scheduled virtual appointments with a cardiologist on 1 day, 1 week, 2 weeks after discharge. If a patient misses a survey, they will be prompted. Patients will also have access to unscheduled health care interviews, virtual appointments, and a hotline for additional questions or concerns. Participants will have access to the RHM education modules and program support for 30 days post hospital discharge.
Participants will be asked to complete questionnaires at three time points: baseline (link to access the questionnaires via REDCap will be sent on the day of hospital discharge), 14 days post discharge, and 30 days post discharge. These include validated tools to assess psychosocial well-being (GAD-7, PHQ-9, EQ-5D-5L, EQ-VAS) and patient activation (PAM-13). They will also complete surveys that cover demographics, health literacy, care transition, unexpected healthcare visits, and satisfaction with care. Responses will be securely collected and stored using REDCap, ensuring both convenience for participants and data integrity for analysis.
