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

NCT07592598 | Not Yet Recruiting DMC

• 1 other identifier: Pro00120135
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure Acute; Point-of-care Ultrasound; Simulation Training; Implementation Science

Keywords

acute heart failure; point-of-care ultrasound; simulation training; implementation science

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)

  up to 6 months post-workshop

• Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM)

  up to 6 months post-workshop

• Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool

  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)

  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

  12 months pre and 12 months post-intervention

Study Arms (1)

Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)

EXPERIMENTAL

Co-designed simulation training intervention and clinical practice guidelines implemenation

Behavioral: Simulation POCUS training; Behavioral: Clinical Practice Guidelines

Interventions

Simulation POCUS training BEHAVIORAL

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.

Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)

Clinical Practice Guidelines BEHAVIORAL

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.

Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners

You may not qualify if:

• ED nurses and technicians are excluded due to differing ultrasound training needs

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Practice Guidelines as Topic

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rebecca Theophanous

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Theophanous, MD, MHSc

CONTACT

9196848111; rebecca.theophanous@duke.edu

Maria Manson

CONTACT

9196848111; maria.manson@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share