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NCT07727304

Overview

NCT ID: NCT07727304
Lead Sponsor: Ottawa Hospital Research InstituteOTHER
Official Title: An Implementation Study to Improve Care of Patients With Acute Heart Failure in the Emergency Department
Brief Summary: Patients with acute heart failure (AHF) commonly present to the emergency department (ED) with difficulty breathing and often have poor outcomes or death. Care of AHF is very complex and, unfortunately, there are no specific guidelines for how physicians should manage AHF in the ED. The investigators recently created the Canadian Association of Emergency Physicians (CAEP) AHF Best Practices Checklist, a concise document that provides specific guidance for ED care.

Our ultimate goal is to conduct a 12-site cluster study to introduce the CAEP AHF Checklist in multiple EDs. Before the investigators can do so, it is essential to demonstrate feasibility in a smaller-scale study. Our objective for this application is to conduct an internal pilot study to demonstrate feasibility of measuring implementation outcomes and refine the protocol if necessary. The investigators will develop strategies to encourage successful adoption of the Checklist by physicians in the ED and allocate 4 large Ontario EDs to implement the Checklist for 1,700 adult AHF patients.

This study will be very important for patients and the healthcare system. If the investigators show that the CAEP AHF Checklist improves patient management and outcomes, this would lead to widespread uptake of the Checklist by all EDs in Canada.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Dec 31, 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

All resident and staff physicians managing patients with AHF in the ED are the primary study participants and this includes emergency, medicine, cardiology, and hospitalists.

The patients that will be included are consecutive adults age >18 years and who present to the ED with recent onset of or recent increase in shortness of breath due to AHF, as determined by health records review.

Eligibility of patients will be reviewed by the blinded study Steering Committee.

Included will be both patients subsequently admitted to hospital and those discharged from the ED, as both will be impacted by the recommendations of the CAEP AHF Checklist.

Exclusion Criteria:

who do not fit the definition of AHF;

if the primary reason for the ED visit was not AHF (e.g. pneumonia, pulmonary embolism);

who have acute myocardial infarction (either ST elevation or non-ST elevation) diagnosed in the ED, because the primary problem for these patients is not heart failure and they require specialized treatment beyond the scope of the Checklist; or

who are considered terminal, with death expected within 60 days.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 5,040Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Ian Stiell, MD, MScContact
istiell@ohri.ca+16137985555 ext. 18683

Similar Studies

Participant Group/Arms

CAEP AHF Checklist ImplementationExperimental

Implementation of the CAEP Acute Heart Failure (AHF) Best Practices Checklist in emergency departments. This includes both the clinical intervention (use of the Checklist to guide assessment, treatment, and disposition of AHF patients) and implementation strategies to promote uptake, such as physician education sessions, local champions, reminders, audit and feedback, and access to a smartphone application

Behavioral: CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation

Usual CareOther

Usual emergency department care for patients with acute heart failure prior to implementation of the CAEP AHF Checklist, with no exposure to active implementation strategies.

Other: Usual care