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

11 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

175

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)
Co-designed simulation training intervention and clinical practice guidelines implemenation
Behawioralne: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12 months pre and 12 months post-intervention
12 months pre and 12 months post-intervention
Ultrasound image interpretation test
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Duke University

Śledczy

  • Główny śledczy: Rebecca Theophanous, Duke University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2030

Ukończenie studiów (Szacowany)

31 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

19 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Pro00120135

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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