NCT07159269

Brief Summary

The aim of this study is to assess emergency medicine physician and advanced practice provider (APP) knowledge and technical skill in performance of a point-of-care ultrasound simulation and just-in-time training pathway to determine the feasibility, acceptability, and usability of the ultrasound training program. By performing this study, we hope to create a standardized training model which could potentially facilitate point-of-care ultrasound (POCUS) clinical performance and thereby improve patient care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
50mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Nov 2025Jun 2030

First Submitted

Initial submission to the registry

August 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 13, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

August 20, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

point of care ultrasoundfocused cardiac ultrasoundadvanced practice provider trainingmedical educationimplementation science

Outcome Measures

Primary Outcomes (4)

  • Aim 1: Assess the feasibility of implementing a just-in-time cardiac point-of-care ultrasound (POCUS) clinical training pathway for advanced practice providers (APPs) using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.

    Participants will complete a cardiac POCUS simulation session and a hands-on structured clinical skill exam post-training (OSCE) led by ultrasound-trained faculty. Then as part of standard clinical care, APPs will perform POCUS while supervised by EM attending physicians. The primary outcome assesses program feasibility and acceptability. Participants will complete a pre/post and 6-month post-survey and semi-structured interview. Survey questions are structured based on the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) survey tool. This is scored on a Likert scale from 1-5.

    1-2 years for each study site

  • Aim 1: 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.

    1-2 years for each study site

  • Aim 1: 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.

    1-2 years for each study site

  • Aim 1: 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.

    1-2 years for each study site

Secondary Outcomes (8)

  • Aim 1: Feasibility of implementing a just-in-time cardiac point-of-care ultrasound (POCUS) clinical training pathway for advanced practice providers (APPs) using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.

    1-2 years for each study site

  • Aim 2: Educational impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance

    1-2 years for each study site

  • Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - number of clinical POCUSs performed

    1-2 years for each study site

  • Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - image quality

    1-2 years for each study site

  • Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - diagnostic accuracy

    1-2 years for each study site

  • +3 more secondary outcomes

Study Arms (1)

Advanced Practice Provider (APP) Cohort

EXPERIMENTAL

Advanced Practice Providers (APPs) are nonphysicians essential to the emergency department workforce, especially in rural and community hospitals.

Behavioral: Cardiac point-of-care ultrasound (POCUS) training and clinical pathway

Interventions

Participants will complete a cardiac POCUS simulation session and a hands-on observed structured clinical skill exam (OSCE) post-training led by ultrasound-trained faculty. Then as part of standard clinical care, advanced practice providers (APPs) will perform POCUS while supervised by emergency medicine (EM) attending physicians. To assess program feasibility and acceptability, participants will complete a pre/post and 6-month post-survey and semi-structured interview, as well as a knowledge and technical skills assessment.

Advanced Practice Provider (APP) Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • advanced practice providers (APPs) currently working in our ED, with additional APPs as they are hired (expected to be about 75 APPs total within the next 3 years due to expanding staffing needs and coverage models).

You may not qualify if:

  • non-APPs such as physicians, nurses, or other clinical staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary EmbolismDiseaseCardiac TamponadePericardial Effusion

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart Diseases

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Rebecca G Theophanous, MD, MHSc

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca G Theophanous, MD, MHSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 8, 2025

Study Start

November 13, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

June 30, 2030

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations