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Clinical Trials/NCT02674438
NCT02674438CompletedPhase 3

Comparison of Outcomes and Access to Care for Heart Failure Trial

Institute for Clinical Evaluative Sciences2 sites in 1 country5,452 target enrollmentStarted: September 2016Last updated:
Conditions

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:

  1. Age 18 years or older
  2. 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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Douglas Lee

Senior Scientist

Institute for Clinical Evaluative Sciences

Study Sites (2)

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