Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Exclusion criteria:
Does not meet Framingham criteria for heart failure
Heart failure diagnosis unlikely according to B-type natriuretic peptide values
End stage renal disease on dialysis
Palliative patient with do not resuscitate (DNR) order present prior to emergency department arrival
Limited mobility to attend outpatient clinic visits
Dementia
Nursing home resident
No permanent home address
Non-resident of Ontario
Self-discharge from emergency department
Invalid Ontario health insurance number
Inclusion and Exclusion Criteria for the RAPID-HF Clinic:
Inclusion criteria:
Patients with heart failure presenting to the emergency department meeting overall study eligibility criteria
Discharged at any time within the first 3 days after emergency department presentation
Using the EHMRG30-ST risk score:
Patient agrees to be discharged early from either the emergency department or hospital
Able to attend outpatient clinic visits
Exclusion criteria:
High risk zone of EHMRG30-ST
Pre-cardiac transplant
Active cardiac ischemia without diagnostic testing done during hospital stay
Uncontrolled arrhythmia
Worsening renal failure compared to baseline renal function
Significant abnormality of vital signs at the time of referral:
New heart failure diagnosis (not an absolute contraindication to referral, but not recommended)
Intervention: The study involves 2 components: clinical algorithm for prognostication and post-discharge follow-up in the Rapid Ambulatory Program for Investigation and Diagnosis of Heart Failure (RAPID-HF) clinic.
The clinical decision-support algorithm intervention is a composite of 7-day and 30-day risk calculator (called EHMRG30-ST). Using the EHMRG30-ST algorithm, patients will be categorized as high, intermediate, or low risk. The decision support algorithm will recommend hospital admission or discharge/observation based on patient risk to assist clinicians making the final decision to admit or discharge. Low risk patients may be discharged early (within 3 days of initial presentation) and referred to the RAPID-HF clinic.
Patients referred to RAPID-HF will be assessed ideally within 48-72 hours of discharge. RAPID-HF provides transitional care for up to 30 days after discharge. After 30-days, care is transferred to primary care provider or specialist for ongoing care.
Study Design: Using a stepped-wedge design, participating sites will be randomized to the active intervention. At each step, hospitals that have not yet been randomized will serve as control sites.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Two components to the intervention: (1) clinical algorithm for prognostication, and (2) post-discharge follow-up in the RAPID-HF clinic Intervention #1 - Clinical algorithm: the EHMRG30-ST risk score which will be used to categorize patients as high, intermediate, or low risk. The clinical algorithm will be used to guide clinicians to decide on admission to hospital, observation during a short stay hospital admission (3 days or less), or emergency department discharge. Intervention #2 - Referral to RAPID-HF (Rapid Ambulatory Program for Investigation and Diagnosis of HF) transitional care clinic: visit to RAPID-HF within 48-72 hours of discharge. Care provided in RAPID-HF by cardiologist + nurse for up to 30 days from date of discharge. |
|
| Control | No Intervention | Usual care without access to the EHMRG30-ST scoring system, decision algorithm, or RAPID-HF clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk stratification and transitional care intervention | Other | Intervention consists of 2 components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary outcome: 30 day early events | Time to composite of death or cardiovascular hospitalization (nonelective, los > 1 day) | 30 days |
| Co-primary outcome: 20 month extended events | Time to composite of death or cardiovascular hospitalization (nonelective, los > 1 day) | 20 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Time to death | 30 days |
| Cardiovascular hospitalization | Time to cardiovascular hospitalization (nonelective, los > 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-centered outcome | Time to nonelective emergency department visit (CTAS 1-4), death or cardiovascular hospitalization | 1) 30-day and 2) 20 month |
| Early discharge | Proportion of patients discharged within 3 days of emergency presentation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Lee, MD, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Genera Hospital | Toronto | Ontario | M5G2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42118536 | Derived | Lee DS, Wang CN, Austin PC, Straus SE, Farkouh ME, Chong A, Taljaard M, Poon S, Smith S, McKelvie RS, Iwanochko RM, MacDougall A, Elbarasi E, Cram PM, Fang J, Atzema CL, Udell JA, Rochon PA, Schull MJ, Mak S, Ross HJ. Risk-Stratified Transitional Care and Cardiovascular Hospitalizations by Sex: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611892. doi: 10.1001/jamanetworkopen.2026.11892. | |
| 36342109 |
Not provided
Not provided
Due to Ontario privacy regulations, unable to share data
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 30 days |
| Heart failure hospitalization | Time to heart failure hospitalization (nonelective, los > 1 day) | 30 days |
| All-cause death | Time to death (nonpalliative) | 20 months |
| Cardiovascular hospitalization | Time to cardiovascular hospitalization (nonelective, los > 1 day) | 20 months |
| Heart failure hospitalization | Time to heart failure hospitalization (nonelective, los > 1 day) | 20 months |
| 3 days |
| Derived |
| Lee DS, Straus SE, Farkouh ME, Austin PC, Taljaard M, Chong A, Fahim C, Poon S, Cram P, Smith S, McKelvie RS, Porepa L, Hartleib M, Mitoff P, Iwanochko RM, MacDougall A, Shadowitz S, Abrams H, Elbarasi E, Fang J, Udell JA, Schull MJ, Mak S, Ross HJ; COACH Trial Investigators. Trial of an Intervention to Improve Acute Heart Failure Outcomes. N Engl J Med. 2023 Jan 5;388(1):22-32. doi: 10.1056/NEJMoa2211680. Epub 2022 Nov 5. |