CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,452 enrolled
Drug / intervention
Risk stratification and transitional care interventionother
Likely dose
Not stated in record
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Search/NCT02674438
NCT02674438Phase 3Completed

Comparison of Outcomes and Access to Care for Heart Failure Trial

Institute for Clinical Evaluative Sciences·interventional·Posted Feb 4, 2016·Updated Oct 6, 2022

In Brief

A Phase 3 clinical trial evaluating Risk stratification and transitional care intervention for Heart Failure. Completed, enrolled 5,452 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 4, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 1, 2021
Study CompletionAug 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.4 years ago

Interventions

Risk stratification and transitional care interventionother

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.