Comparison of Outcomes and Access to Care for Heart Failure Trial

NCT02674438 | Completed Phase 3

• 1 other identifier: 2
• Study Type: interventional
• Target: 5,452
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• All-cause death

  30 days

• Cardiovascular hospitalization

  30 days

• Heart failure hospitalization

  30 days

• All-cause death

  20 months

• Cardiovascular hospitalization

  20 months

Other Outcomes (2)

• Patient-centered outcome

  1) 30-day and 2) 20 month

• Early discharge

  3 days

Study Arms (2)

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.

Other: Risk stratification and transitional care intervention

Control

NO INTERVENTION

Usual care without access to the EHMRG30-ST scoring system, decision algorithm, or RAPID-HF clinic.

Interventions

Risk stratification and transitional care intervention OTHER

Intervention consists of 2 components: 1. Risk stratification: Determination of risk using the EHMRG 7-day and 30-day risk scores (EHMRG30-ST), where decision to admit, observe, or discharge the patient will be guided by the result of the risk scores 2. Transitional care: Follow-up care in the RAPID-HF transitional care clinic begins at 48-72 hours after emergency department or hospital discharge. Care provided by cardiologist + nurse for up to 30 days after emergency department or hospital discharge.

Active Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presenting to an emergency department with heart failure

You may not qualify if:

• Palliative or DNR
• Dialysis dependent
• Non-Ontario resident

Sponsors & Collaborators

• Institute for Clinical Evaluative Sciences: lead

Study Sites (1)

Toronto Genera Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 36342109 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Douglas Lee, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 4, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: August 1, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)