Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
2026年5月11日 更新者：Duke University
Co-design and Implementation of a Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
The aim of this study is to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians and evaluate the effectiveness of the cardiac point-of-care ultrasound (POCUS) simulation-based training (CPST) and CPG implementation.
By performing this study, the investigators hope to improve diagnostic processes and time-to-diuretic dosing for acute heart failure (AHF) patients.
調査の概要
状態
まだ募集していません
詳細な説明
Cardiac disease is the leading cause of mortality worldwide, with over 6.7 million Americans with acute heart failure (AHF) presenting with 1 million annual emergency department (ED) visits.
Point-of-care ultrasound (POCUS) is a critical bedside tool that can expedite diagnosis and treatment in AHF patients.
However, gaps in POCUS training remain that limit clinical utilization.
Simulation-based training reinforces technical skills for clinical application.
Prior work achieved high procedural knowledge (70% passed, 18% SD) and technical skills (95%, 6% SD) in emergency medicine (EM) clinicians using a simulation nerve block model, with retention at 3-months post-intervention.
The current proposed study builds on this work, using the Implementation Research Longitudinal Framework (IRLM) to translate knowledge into clinical skills through simulation-based POCUS training for EM physicians and Advanced Practice Providers (APPs) to improve time-to-diuretics and AHF patient clinical outcomes.
Specific Aim 1 uses adaptive Experience-Based Co-design (EBCD) to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians The cardiac POCUS training workshop and reinforcement sessions will be co-designed with ED leadership, ultrasound faculty, and key stakeholders.
Participants will then perform cardiac and lung POCUS using standardized clinical practice guidelines (CPG) in AHF patients as part of clinical care.
Specific Aim 2 is the intervention assessment.
We will assess pre-, post, and 6-month post-simulation participant POCUS skills using validated ultrasound self-efficacy scales, image interpretation tests (knowledge), and simulated scenario performance (technical skills).
Specific Aim 3 evaluates the effectiveness of the cardiac POCUS simulation-based training and clinical practice guideline implementation.
The investigators will perform a quasi-experimental pre-/post design by interrupted time series with one year of data before and after intervention implementation.
We will perform a quasi-experimental pre-/post design interrupted time series with one year of data before and after intervention implementation in three diverse EDs.
Our primary clinical outcome is time-to-diuretic dose in ED heart failure patients.11
PROCTOR-guided outcomes include effectiveness, provider adoption, and clinical POCUS uptake/utilization.
研究の種類
介入
入学 (推定)
175
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：Rebecca Theophanous, MD, MHSc
- 電話番号：9196848111
- メール：rebecca.theophanous@duke.edu
研究連絡先のバックアップ
- 名前：Maria Manson
- 電話番号：9196848111
- メール：maria.manson@duke.edu
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
はい
説明
Inclusion Criteria:
- Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners
Exclusion Criteria:
- ED nurses and technicians are excluded due to differing ultrasound training needs
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：診断
- 割り当て：なし
- 介入モデル：順次割り当て
- 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：Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)
Co-designed simulation training intervention and clinical practice guidelines implemenation
|
Uses adaptive Experience-Based Co-design (EBCD) to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians.
The cardiac POCUS training workshop and reinforcement sessions will be co-designed with ED leadership, ultrasound faculty, and key stakeholders.
Participants will then perform cardiac and lung POCUS using standardized clinical practice guidelines (CPG) in AHF patients as part of clinical care.
Clinical practice guidelines will instruct clinicians on how to perform POCUS, save the images, complete worksheets on the archiving platform, and signed so that images are saved to the patient's chart and billed.
|
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 |
|---|---|---|
|
Effectiveness of the simulation-based cardiac POCUS (Point-of-Care Ultrasound) training implementation as measured by time-to-diuretic dose in ED (Emergency Department) heart failure patients
時間枠：12 months pre and 12 months post-intervention
|
Time-to-diuretics (units in minutes) in patients with a clinical diagnosis of acute heart failure with reduced or preserved ejection fraction.
|
12 months pre and 12 months post-intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)
時間枠：up to 6 months post-workshop
|
The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability.
|
up to 6 months post-workshop
|
|
Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM)
時間枠：up to 6 months post-workshop
|
The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
|
up to 6 months post-workshop
|
|
Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool
時間枠：up to 6 months post-workshop
|
The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
|
up to 6 months post-workshop
|
|
Feasibility of implementing a cardiac point-of-care ultrasound (POCUS) simulation training and clinical practice guidelines for physicians and advanced practice providers (APPs)
時間枠：12 months pre and 12 months post-intervention
|
Using a modified framework analysis approach, a team of 3-4 trained research assistants and ultrasound faculty led by an implementation science expert will deductively analyze semi-structured interview content based on IRLM constructs and PROCTOR outcomes, with open inductive coding for data that does not fit into the framework.
A preliminary rapid qualitative deductive analysis will be performed based on audio recordings and meeting notes applied to the PROCTOR dimensions, to determine scope and saturation.
Coding and categorization will be conducted with PROCTOR-templated coding sheets and transferred to NVivo.
|
12 months pre and 12 months post-intervention
|
|
Effectiveness of the simulation-based cardiac POCUS training implementation as measured by the number of clinical POCUS performed in the ED
時間枠：12 months pre and 12 months post-intervention
|
To assess the cardiac POCUS simulation training program effectiveness, the investigators will collect pre/post-health record data on the number of clinical POCUS performed in the emergency department pre/post-intervention (from the Butterfly ultrasound archiving system, units in counts/percentages).
|
12 months pre and 12 months post-intervention
|
|
Effectiveness of the simulation-based cardiac POCUS training implementation as measured by image quality review scores
時間枠：12 months pre and 12 months post-intervention
|
To assess cardiac POCUS simulation training program effectiveness, the investigators will collect pre/post-health record data on image quality review scores (determine by two ultrasound experts, Likert scale 1-5, where a higher score indicates greater quality).
|
12 months pre and 12 months post-intervention
|
|
Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by the time to initial cardiology consult
時間枠：12 months pre and 12 months post-intervention
|
The investigators will collect electronic health record data on pre/post-intervention time to initial cardiology consult (both from the Epic electronic health record, units in hours).
|
12 months pre and 12 months post-intervention
|
|
Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by emergency department length-of-stay
時間枠：12 months pre and 12 months post-intervention
|
The investigators will collect electronic health record data on pre/post-intervention ED length-of-stay (from the Epic electronic health record, units in hours).
|
12 months pre and 12 months post-intervention
|
|
Clinical impact of the training model on heart failure patients as measured by the number of participants with serious cardiac outcomes
時間枠：12 months pre and 12 months post-intervention
|
The investigators will collect pre/post-intervention 30-day serious cardiac outcomes including 30-day mortality, ventilation, new dialysis, myocardial infarction (from the Epic electronic health record, units in counts/percentages).
|
12 months pre and 12 months post-intervention
|
|
Ultrasound Self-efficacy Scale
時間枠：6 months
|
Post-workshop assessments will assess participant skills via validated Ultrasound Self-efficacy Scale, which is reported on a scale of 1 to 5. A higher score indicates greater self-efficacy.
|
6 months
|
|
Provider adoption as measured by the number of cardiac/lung POCUS exams performed by each participant for ED acute heart failure patients
時間枠：12 months pre and 12 months post-intervention
|
12 months pre and 12 months post-intervention
|
|
|
Ultrasound image interpretation test
時間枠：6 months
|
Post-workshop assessments will assess participant skills via validated ultrasound image interpretation tests (knowledge assessment survey, 11 questions multiple choice).
Scores range from 0 to 11, where a higher score indicates greater knowledge.
|
6 months
|
|
Ultrasound Competency Assessment Test (UCAT)
時間枠：6 months
|
Post-workshop assessments will assess participant skills via validated ultrasound simulated scenario performance and technical skills using the UCAT.
The score ranges from 1 ("I had to do", total supervisor intervention) to 5 ("I did not need to be there", independent).
Higher scores indicate greater competency.
|
6 months
|
|
Cost-effectiveness as measured by POCUS (Point-of-Care Ultrasound) revenue
時間枠：12 months pre and 12 months post-intervention
|
Number of dollars billed at a flat rate for each procedure type from the Butterfly enterprise and hospital clinical billing data archive, units in dollars.
|
12 months pre and 12 months post-intervention
|
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。
スポンサー
捜査官
- 主任研究者：Rebecca Theophanous、Duke University
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9月1日
一次修了 (推定)
2030年12月31日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2026年3月19日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00120135
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
All data will be collected in hospital secured platforms including Duke REDCap, the current clinical Butterfly Enterprise POCUS archiving system, and Epic electronic health records. All data will be de-identified at the collection step and kept as de-identified data for our research purposes. Data will be collected in digital format and stored using standardized file types such as .csv, .txt, .docx, .mp3. The total data volume will cover about 175 participants across 2-3 hospital sites.
The research community will have access to data when the award ends. As required by NHLBI, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available and have digital object identifiers (DOI) to aid in findability. The investigators will include the DOI in relevant publications. NHLBI will make decisions about how long to preserve the data.
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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