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Implementation of Acute Heart Failure Checklist

2026年7月22日 更新者:Ottawa Hospital Research Institute

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

5040

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Ian Stiell, MD, MSc
  • 電話番号:18683 +16137985555
  • メール:istiell@ohri.ca

研究場所

    • Ontario
      • Ottawa、Ontario、カナダ、K1Y 4E9
        • Ottawa Hospital Research Institute
        • コンタクト:
          • Ian Stiell, MD, MSc
          • 電話番号:18683 6137985555
          • メール:istiell@ohri.ca

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:CAEP AHF Checklist Implementation
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
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.
他の:Usual Care
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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
全死因死亡
時間枠:30日以内
30日以内
Number of Participants With Deterioration During the Index Visit
時間枠:within 24 hours
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
時間枠: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.
Within 14 days of the index emergency department visit

二次結果の測定

結果測定
メジャーの説明
時間枠
Length of Stay in the Emergency Department
時間枠:Up to 14 days following the index emergency department visit
Emergency department length of stay for the index visit.
Up to 14 days following the index emergency department visit
Number of Participants Admitted to Hospital Immediately or Within 30 Days
時間枠:Within 30 days of the index emergency department visit
Hospital admission occurring during the index emergency department visit or within 30 days of the index visit.
Within 30 days of the index emergency department visit
Length of Stay in Hospital
時間枠:Within 30 days of the index emergency department visit
Hospital length of stay for participants admitted during the index visit or within 30 days of the index emergency department visit.
Within 30 days of the index emergency department visit
Number of Participants With a Repeat Emergency Department Visit
時間枠:Within 14 days of the index emergency department visit
Repeat emergency department visit for any reason following the index emergency department visit.
Within 14 days of the index emergency department visit

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Ian Stiell, MD, MSc、Ottawa Hospital Research Institute

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2029年12月31日

研究の完了 (推定)

2030年6月1日

試験登録日

最初に提出

2026年7月3日

QC基準を満たした最初の提出物

2026年7月22日

最初の投稿 (実際)

2026年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月22日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Requests to be submitted to the Principal Investigator and the study team will review on a case-by-case basis.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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