Comparison of Outcomes and Access to Care for Heart Failure Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 5,452
- Locations
- 2
- Primary Endpoint
- Co-primary outcome: 30 day early events
Study Overview
Brief Summary
Heart failure is a condition where the heart pump does not function normally causing the lungs to become congested. The primary symptom of heart failure is shortness of breath, and this often leads to patients visiting the emergency department for care. Decision-making in the emergency department is a high-stakes situation, where there is a need for decision support to guide clinicians to make better decisions about admission to hospital or discharge home. Many low-risk patients who could potentially be managed at home are admitted to hospital whereas some patients who are thought safe to discharge are actually high risk and will have adverse outcomes if they are discharged home from the emergency department.
In this trial, the investigators will study a new strategy for heart failure care, comprised of a computer algorithm to help doctors make decisions in the emergency department about the risk of their patient. For low-risk patients who are discharged home from the emergency department or after a short hospital stay, patients will be referred to a rapid follow-up clinic where the heart specialist team will rapidly assess and treat patients.
Detailed Description
Overview: Randomized intervention trial to examine the impact of an acute heart failure strategy, which incorporates risk stratification and rapid outpatient care after discharge.
Study Population: Patients presenting to the emergency department with heart failure will be eligible for study inclusion.
Inclusion and Exclusion Criteria for the Study:
- Age 18 years or older
- Presents to the emergency department with acute heart failure diagnosed clinically and verified by a primary diagnosis of heart failure (ICD-10-CA code I50) on the emergency department facesheet.
Exclusion criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient presenting to an emergency department with heart failure
Exclusion Criteria
- •Palliative or DNR
- •Dialysis dependent
- •Non-Ontario resident
Outcomes
Primary Outcomes
Co-primary outcome: 30 day early events
Time Frame: 30 days
Time to composite of death or cardiovascular hospitalization (nonelective, los \> 1 day)
Co-primary outcome: 20 month extended events
Time Frame: 20 month follow-up
Time to composite of death or cardiovascular hospitalization (nonelective, los \> 1 day)
Secondary Outcomes
- All-cause death(20 months)
- Cardiovascular hospitalization(20 months)
- Heart failure hospitalization(20 months)
Investigators
Douglas Lee
Senior Scientist
Institute for Clinical Evaluative Sciences
