Implementation of Acute Heart Failure Checklist
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation
BehavioralImplementation 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 care
Other interventionStandard emergency department care for patients with acute heart failure prior to implementation of the CAEP AHF Checklist, with no exposure to active implementation strategies.
Treatment groups
5,040 Participants
are divided into 2 treatment groupsGroup A: CAEP AHF Checklist ImplementationExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
Time frame
within 30 days2
Number of Participants With Deterioration During the Index Visit
deterioration during index visit, defined as requiring endotracheal intubation or mechanical non-invasive ventilation
Time frame
within 24 hours3
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.
Time frame
Within 14 days of the index emergency department visitSecondary outcomes
1
Length of Stay in the Emergency Department
Emergency department length of stay for the index visit.
Time frame
Up to 14 days following the index emergency department visit2
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.
Time frame
Within 30 days of the index emergency department visit3
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.
Time frame
Within 30 days of the index emergency department visit4
Number of Participants With a Repeat Emergency Department Visit
Repeat emergency department visit for any reason following the index emergency department visit.
Time frame
Within 14 days of the index emergency department visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Hospital Research Institute
Lead sponsor
The Ottawa Hospital Academic Medical Association
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: