TPD-REACH: Tailoring Post Discharge - Remote Education and Access for Cardiac Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence of Unexpected Healthcare Visits
研究概览
简要总结
Heart attacks are one of the top causes of death in Canada, with over 2,100 cases treated each year in Manitoba. Even though hospital care has improved, the period after going home is still risky. Many patients feel anxious and unsure about their recovery, and without enough support, they often end up back in the emergency department (ED). This is an even bigger challenge for people in rural areas, where getting follow-up care can be much harder. Filling these gaps is important to help patients get better and to reduce stress on the healthcare system.
In a previous study, the investigators found that extra support made a big difference: only 8% of participants using a digital health tool returned to the ED within 30 days, compared to 22% of participants without it. Now, the investigators want to expand this study across Manitoba to see if digital health tools can help more people recover safely at home. The investigators will compare two types of follow-up care: education only versus education with extra support (like symptom tracking and virtual appointments). The investigators will look at how this affects hospital visits, mental well-being, and healthcare costs. The goal is to create a better support system for people after a heart attack, leading to healthier recoveries, less strain on hospitals, and better care for Manitobans - no matter where they live.
详细描述
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:
- 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
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old, type 1 myocardial infarction27, resident of Manitoba
排除标准
- •Patients unable to consent or fully participate in the study due to:
- •Technology barriers
- •Lack of digital device, internet access or data
- •Discomfort with using technology
- •Communication or language barriers preventing participation
- •Cognitive or mental health limiting informed consent or participation
- •Dementia or cognitive impairment
- •Active or severe psychosis or other significant mental health conditions c. Active substance abuse
- •High-risk ACS where patients require more frequent or in person visits a. Cardiac:
- •i. Coronary
- •Unrevascularizedleftmainormultivessellargeepicardialcoronary artery disease (>2.5mm)
- •Coronary artery bypass surgery (CABG) during index hospitalization ii. Arrhythmias
- •Cardiac arrest during index event/hospitalization (ventricular tachycardia (VT)/ventricular fibrillation (VF), pulseless electrical activity (PEA)) iii. Cardiomyopathy
- •Left ventricular ejection fraction (LVEF) <35% (most recent EF assessment)
- •Cardiogenic shock requiring pressors/inotropes for more than 24 hours
- •Requiring intubation/positive pressure ventilation/hi-flow oxygen for more than 24 hours
- •Switchedfromintravenous(IV)tooral(PO)loopdiureticwithinlast 48 hours
- •Change in PO loop diuretic dose within last 48 homes (home re- start of 80mg or less is allowed)
- •B-type natriuretic peptide (BNP) did not reduce by 30% iv. Cardiac Care Unit (CCU)/Intensive Care Unit (ICU) o Any CCU/ICU stay for more than 24 hours b. Medical: i. any condition with prognosis less than 1 year or a high LACE (Length of stay, Acuity of admission, Comorbidities, Emergency department use) score (>15)28 ii. any medical comorbidity requiring in-person assessment within 2 weeks TPD-REACH PROTOCOL v3 29Aug2025 8 of 17 TPD-REACH: Remote Education and Access for Cardiac Health iii. transition to an alternative living arrangement/compromised independent living iv. need medication adjustment or investigation within 2 weeks c. Social: i. severe financial strain ii. no fixed address or housing instability iii. severe food insecurity iv. significant hearing or vision impairment v. poor health literacy While we aim to promote health equity, patients facing these challenges need more support than this project can offer and should be connected to appropriate services before discharge.
- •Non-atherosclerotic causes of ACS (spontaneous coronary artery dissection, stress- induced cardiomyopathy, myocarditis) as the education and treatment is different
- •Any additional factor preventing full participation in the study
结局指标
主要结局
Incidence of Unexpected Healthcare Visits
时间窗: 30 days post hospital discharge
30-day unexpected healthcare visits (including emergency department, urgent care, walk in clinic or nursing station)
次要结局
- Individual Components of Composite Events(30 days post hospital discharge)
- Composite of Events(30 days post hospital discharge)
- Individual Components of Composite Unexpected Healthcare Visits(30 days post hospital discharge)
- PAM-13 - Patient Activation Measure(Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge)
- Generalized Anxiety Disorder (GAD) - 7(Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge)
- Patient Health Questionnaire (PHQ) - 9(Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge)
- EQ-5D-5L - Health Related Quality of Life(Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge)
- EQ-VAS - Health Related Quality of Life(Baseline (day of hospital discharge), 14 days post hospital discharge, and 30 days post hospital discharge)
- Patient Satisfaction Questionnaire(At 30 days post hospital discharge)
- Overall Healthcare Cost Savings per Patient(30 days post hospital discharge)
研究者
Shuangbo Liu
Interventional Cardiologist
St. Boniface Hospital
