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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Implementation Science; Simulation Training; Heart Failure Acute; Point-of-care Ultrasound
• Intervention / Treatment: Behavioral: Simulation POCUS training; Behavioral: Clinical Practice Guidelines

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Theophanous, MD, MHSc; Phone Number: 9196848111; Email: rebecca.theophanous@duke.edu
• Study Contact Backup: Name: Maria Manson; Phone Number: 9196848111; Email: maria.manson@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs); Co-designed simulation training intervention and clinical practice guidelines implemenation

Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)	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)	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	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)	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	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	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	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	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	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	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		12 months pre and 12 months post-intervention
Ultrasound image interpretation test	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)	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Rebecca Theophanous, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: implementation science; acute heart failure; point-of-care ultrasound; simulation training
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Guidelines as Topic; Quality Assurance, Health Care; Practice Guidelines as Topic
• Other Study ID Numbers: Pro00120135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No