Implementation of Acute Heart Failure Checklist

Официальное название

An Implementation Study to Improve Care of Patients With Acute Heart Failure in the Emergency Department

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое CAEP Acute Heart Failure (AHF) Best Practices Checklist Implementation
  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 adh
• Другое Usual care
  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.

Первичные конечные точки

• All-cause mortality [Срок оценки: within 30 days]
• Number of Participants With Deterioration During the Index Visit [Срок оценки: within 24 hours]
• Number of Participants With Relapse to the Emergency Department for a Related Medical Condition Requiring Hospital Admission Within 14 Days [Срок оценки: Within 14 days of the index emergency department visit]

Вторичные конечные точки (4)

• Length of Stay in the Emergency Department [Срок оценки: Up to 14 days following the index emergency department visit]
• Number of Participants Admitted to Hospital Immediately or Within 30 Days [Срок оценки: Within 30 days of the index emergency department visit]
• Length of Stay in Hospital [Срок оценки: Within 30 days of the index emergency department visit]
• Number of Participants With a Repeat Emergency Department Visit [Срок оценки: Within 14 days of the index emergency department visit]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Ottawa Hospital Research Institute — Ottawa

Идентификаторы

NCT: NCT07727304 · 20260224-01T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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