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Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients

11. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

175

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)
Co-designed simulation training intervention and clinical practice guidelines implemenation
Verhalten: Simulation POCUS training
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.
Verhalten: Clinical Practice Guidelines
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 months pre and 12 months post-intervention
12 months pre and 12 months post-intervention
Ultrasound image interpretation test
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Duke University

Ermittler

  • Hauptermittler: Rebecca Theophanous, Duke University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2030

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

19. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Pro00120135

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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