Acute Heart Failure (AHF)NCT07727304
Implementation of Acute Heart Failure Checklist
A study testing CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation in people with Acute Heart Failure (AHF) and Implementation Research, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Implementation Research
- What is being tested?
- CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,040 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2026to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Implementation Study to Improve Care of Patients With Acute Heart Failure in the Emergency Department
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.
Read the detailed description
Background: Heart failure is a syndrome that results from impairment of ventricular filling or ejection of blood. Patients with acute heart failure (AHF) commonly present to the emergency department (ED) with increased shortness of breath and often have poor outcomes or death. Management of AHF is very complex and entails assessment, multiple treatment options, and the difficult decision of whether to hospitalize or discharge. Unfortunately, there are no specific guidelines for how to manage AHF in the ED. The Canadian Cardiovascular Society (CCS) has very detailed high-quality guidelines for heart failure, but these are not specific for AHF or the ED setting.
The investigators recently created the Canadian Association of Emergency Physicians (CAEP) AHF Best Practices Checklist by adapting the CCS guidelines with a panel of 32 emergency physicians, cardiologists, intern-ists, methodologists, and patients. This concise document provides specific guidance for ED physicians and was recently published (Can J Emerg Med Sept 2025).
Study Objective: Our overall goal is to improve care of AHF patients in Canadian EDs and our specific objective is to conduct an implementation study of the CAEP AHF Checklist to decrease mortality and morbidity.
Methods: Design: Cross-sectional 4-sequence 5 period stepped-wedge cluster study in which the "clinical intervention" is the CAEP AHF Checklist, and the "implementation intervention" is the introduction of the Checklist into ED physician practice. Over 30 months, 3 hospitals will cross over every 6 months from the control to the intervention period. There will be a 2-month transition period. Setting: 12 large EDs in 5 provinces. Subjects: All physicians managing AHF in the ED are the primary study participants (emergency, medicine, cardiology, and hospitalists). The patients to be included are consecutive adults age >18 who present with shortness of breath due to AHF. Interventions: The clinical intervention is the CAEP AHF Checklist and the implementation intervention are the behaviour change strategies to encourage the adoption of and adherence to the Checklist into the practice of the physicians managing AHF patients (during the intervention periods of the trial). Outcomes: The primary outcome will be a composite of 3 clinical effectiveness variables: 1) Mortality <30 days, 2) Deterioration post index visit admission, requiring endotracheal intubation or non-invasive ventilation, or 3) Relapse back to ED requiring hospital admission <14 days. Secondary effectiveness outcomes include any of the individual com-ponents of the composite primary outcome. Secondary implementation outcomes include adherence to the Checklist by review of quality indicators and surveys to measure penetration and acceptability. Data Analysis: The primary outcome will be analyzed according to the intention to treat principle, adhering to the randomized schedule of implementation. The unit of analysis will be the individual patient using mixed effects logistic regression accounting for the stepped wedge design. A priori subgroups will be sex male/female, age >75/<75 years, and admitted/discharged. Sample Size: The investigators estimate a total enrollment of 5,040 cases.
Importance: If the investigators demonstrate that local implementation of the CAEP AHF Checklist improves patient management and outcomes, this justifies widespread scaling of the initiative to all EDs in Canada and elsewhere worldwide.
- Conditions
- Acute Heart Failure (AHF), Implementation Research
- Being tested
- CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation, Usual care
- Keywords
- Best Practices Checklist, Acute Heart Failure, Emergency Department, Guidelines, Implementation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAEP Acute Heart Failure (AHF) Best Practices Checklist ImplementationBehavioural
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 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
Measured: 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.
Measured: Within 14 days of the index emergency department visit
Secondary outcomes (4)
Length of Stay in the Emergency Department
Emergency department length of stay for the index visit.
Measured: Up to 14 days following the index emergency department visit
Number of Participants Admitted to Hospital Immediately or Within 30 Days
Hospital admission occurring during the index emergency department visit or within 30 days of the index visit.
Measured: Within 30 days of the index emergency department visit
Length of Stay in Hospital
Hospital length of stay for participants admitted during the index visit or within 30 days of the index emergency department visit.
Measured: Within 30 days of the index emergency department visit
Number of Participants With a Repeat Emergency Department Visit
Repeat emergency department visit for any reason following the index emergency department visit.
Measured: Within 14 days of the index emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start15 Aug 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Ian Stiell, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727304
- Sponsor's protocol ID
- 20260224-01T
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests to be submitted to the Principal Investigator and the study team will review on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Study to Improve Care of Patients With Acute Heart Failure in the Emergency Department
- ClinicalTrials.gov ID
- NCT07727304
- Acronym / sponsor ID
- 20260224-01T
- Conditions
- Acute Heart Failure (AHF), Implementation Research
- Keywords
- Best Practices Checklist, Acute Heart Failure, Emergency Department, Guidelines, Implementation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,040 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Heart failure is a syndrome that results from impairment of ventricular filling or ejection of blood. Patients with acute heart failure (AHF) commonly present to the emergency department (ED) with increased shortness of breath and often have poor outcomes or death. Management of AHF is very complex and entails assessment, multiple treatment options, and the difficult decision of whether to hospitalize or discharge. Unfortunately, there are no specific guidelines for how to manage AHF in the ED. The Canadian Cardiovascular Society (CCS) has very detailed high-quality guidelines for heart failure, but these are not specific for AHF or the ED setting.
The investigators recently created the Canadian Association of Emergency Physicians (CAEP) AHF Best Practices Checklist by adapting the CCS guidelines with a panel of 32 emergency physicians, cardiologists, intern-ists, methodologists, and patients. This concise document provides specific guidance for ED physicians and was recently published (Can J Emerg Med Sept 2025).
Study Objective: Our overall goal is to improve care of AHF patients in Canadian EDs and our specific objective is to conduct an implementation study of the CAEP AHF Checklist to decrease mortality and morbidity.
Methods: Design: Cross-sectional 4-sequence 5 period stepped-wedge cluster study in which the "clinical intervention" is the CAEP AHF Checklist, and the "implementation intervention" is the introduction of the Checklist into ED physician practice. Over 30 months, 3 hospitals will cross over every 6 months from the control to the intervention period. There will be a 2-month transition period. Setting: 12 large EDs in 5 provinces. Subjects: All physicians managing AHF in the ED are the primary study participants (emergency, medicine, cardiology, and hospitalists). The patients to be included are consecutive adults age >18 who present with shortness of breath due to AHF. Interventions: The clinical intervention is the CAEP AHF Checklist and the implementation intervention are the behaviour change strategies to encourage the adoption of and adherence to the Checklist into the practice of the physicians managing AHF patients (during the intervention periods of the trial). Outcomes: The primary outcome will be a composite of 3 clinical effectiveness variables: 1) Mortality <30 days, 2) Deterioration post index visit admission, requiring endotracheal intubation or non-invasive ventilation, or 3) Relapse back to ED requiring hospital admission <14 days. Secondary effectiveness outcomes include any of the individual com-ponents of the composite primary outcome. Secondary implementation outcomes include adherence to the Checklist by review of quality indicators and surveys to measure penetration and acceptability. Data Analysis: The primary outcome will be analyzed according to the intention to treat principle, adhering to the randomized schedule of implementation. The unit of analysis will be the individual patient using mixed effects logistic regression accounting for the stepped wedge design. A priori subgroups will be sex male/female, age >75/<75 years, and admitted/discharged. Sample Size: The investigators estimate a total enrollment of 5,040 cases.
Importance: If the investigators demonstrate that local implementation of the CAEP AHF Checklist improves patient management and outcomes, this justifies widespread scaling of the initiative to all EDs in Canada and elsewhere worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAEP AHF Checklist Implementation | Experimental | Behavioral: CAEP Acute Heart Failure (AHF) Best Practices Checklist ImplementationImplementation 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 |
| Usual Care | Other | Other: Usual careUsual emergency department care for patients with acute heart failure prior to implementation of the CAEP AHF Checklist, with no exposure to active implementation strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAEP Acute Heart Failure (AHF) Best Practices Checklist ImplementationImplementation 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. | Behavioural | CAEP AHF Checklist Implementation |
| Usual careStandard 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 |
Primary outcome
All-cause mortality
Time frame: within 30 days
Number of Participants With Deterioration During the Index Visit
Time frame: within 24 hours
deterioration during index visit, defined as requiring endotracheal intubation or mechanical non-invasive ventilation
Number of Participants With Relapse to the Emergency Department for a Related Medical Condition Requiring Hospital Admission Within 14 Days
Time frame: Within 14 days of the index emergency department visit
Relapse back to the emergency department for a related medical condition requiring hospital admission within 14 days of the index emergency department visit.
4 secondary outcomes
Length of Stay in the Emergency Department
Time frame: Up to 14 days following the index emergency department visit
Number of Participants Admitted to Hospital Immediately or Within 30 Days
Time frame: Within 30 days of the index emergency department visit
Length of Stay in Hospital
Time frame: Within 30 days of the index emergency department visit
Number of Participants With a Repeat Emergency Department Visit
Time frame: Within 14 days of the index emergency department visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Requests to be submitted to the Principal Investigator and the study team will review on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Stiell, MD, MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation in people with Acute Heart Failure (AHF) and Implementation Research, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: within 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.