Heart Failure Clinical Trial
— COACHOfficial title:
Comparison of Outcomes and Access to Care for Heart Failure Trial
NCT number | NCT02674438 |
Other study ID # | 2 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | August 2022 |
Verified date | October 2022 |
Source | Institute for Clinical Evaluative Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5452 |
Est. completion date | August 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient presenting to an emergency department with heart failure Exclusion Criteria: - Palliative or DNR - Dialysis dependent - Non-Ontario resident |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Genera Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Institute for Clinical Evaluative Sciences |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient-centered outcome | Time to nonelective emergency department visit (CTAS 1-4), death or cardiovascular hospitalization | 1) 30-day and 2) 20 month | |
Other | Early discharge | Proportion of patients discharged within 3 days of emergency presentation | 3 days | |
Primary | Co-primary outcome: 30 day early events | Time to composite of death or cardiovascular hospitalization (nonelective, los > 1 day) | 30 days | |
Primary | Co-primary outcome: 20 month extended events | Time to composite of death or cardiovascular hospitalization (nonelective, los > 1 day) | 20 month follow-up | |
Secondary | All-cause death | Time to death | 30 days | |
Secondary | Cardiovascular hospitalization | Time to cardiovascular hospitalization (nonelective, los > 1 day) | 30 days | |
Secondary | Heart failure hospitalization | Time to heart failure hospitalization (nonelective, los > 1 day) | 30 days | |
Secondary | All-cause death | Time to death (nonpalliative) | 20 months | |
Secondary | Cardiovascular hospitalization | Time to cardiovascular hospitalization (nonelective, los > 1 day) | 20 months | |
Secondary | Heart failure hospitalization | Time to heart failure hospitalization (nonelective, los > 1 day) | 20 months |
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