Implementation of Acute Heart Failure Checklist

NCT07727304 | Not Yet Recruiting

• 1 other identifier: 20260224-01T
• Study Type: interventional
• Target: 5,040
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure (AHF); Implementation Research

Keywords

Best Practices Checklist; Acute Heart Failure; Emergency Department; Guidelines; Implementation

Outcome Measures

Primary Outcomes (3)

• All-cause mortality

  within 30 days

• Number of Participants With Deterioration During the Index Visit

  deterioration during index visit, defined as requiring endotracheal intubation or mechanical non-invasive ventilation

  within 24 hours

• Number of Participants With Relapse to the Emergency Department for a Related Medical Condition Requiring Hospital Admission Within 14 Days

  Relapse back to the emergency department for a related medical condition requiring hospital admission within 14 days of the index emergency department visit.

  Within 14 days of the index emergency department visit

Secondary Outcomes (4)

• Length of Stay in the Emergency Department

  Up to 14 days following the index emergency department visit

• Number of Participants Admitted to Hospital Immediately or Within 30 Days

  Within 30 days of the index emergency department visit

• Length of Stay in Hospital

  Within 30 days of the index emergency department visit

• Number of Participants With a Repeat Emergency Department Visit

  Within 14 days of the index emergency department visit

Study Arms (2)

CAEP AHF Checklist Implementation

EXPERIMENTAL

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 Care

OTHER

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

Interventions

CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation BEHAVIORAL

Implementation of the CAEP Acute Heart Failure (AHF) Best Practices Checklist to guide physician assessment, treatment, and disposition of patients presenting with AHF in the emergency department. The intervention includes structured implementation strategies to support behavior change and uptake, including identification of local physician champions, education sessions and presentations, review of barriers and facilitators, development of local action plans, reminders, audit and feedback on adherence, and access to a smartphone application providing the Checklist as a point-of-care reference.

CAEP AHF Checklist Implementation

Usual care OTHER

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

Usual Care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Stiell, MD, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Stiell, MD, MSc

CONTACT

+16137985555; istiell@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators propose a type I hybrid effectiveness implementation design that focuses primarily on the effectiveness outcomes of a clinical intervention while exploring the "implementability" of the intervention. The investigators will do this with a cross-sectional 4-sequence 5 period stepped-wedge cluster study in which the clinical intervention is the CAEP AHF Best Practices Checklist and the implementation intervention is the introduction of the Checklist into the practice of physicians managing patients with AHF in the ED.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)