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RecruitingNCT07159269Updated Jun 3, 2026

Cardiac point-of Care Ultrasound Training Pathway for Emergency Department Advanced Practice Providers

An interventional study of Cardiac point-of-care ultrasound (POCUS) training and clinical pathway in Cardiovascular Disease Acute, Emergency Department Patient and Heart Failure Acute, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cardiovascular Disease Acute
  • Emergency Department Patient
  • Heart Failure Acute
  • Pulmonary Embolism (Diagnosis)
  • Point of Care Ultrasound (POCUS)
  • Cardiac Tamponade
  • Pericardial Effusion
  • Diagnostic Imaging
  • Medical Training
  • Implementation Science

Keywords

  • point of care ultrasound
  • focused cardiac ultrasound
  • advanced practice provider training
  • medical education
  • implementation science
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In context

Pulmonary Embolism

832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.

This study's planned enrollment of 75 is below the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Advanced Practice Provider (APP) Cohort

    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

  • BehavioralCardiac point-of-care ultrasound (POCUS) training and clinical pathway

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-2 years for each study site

  2. 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.

    Time frame: 1-2 years for each study site

  3. 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.

    Time frame: 1-2 years for each study site

  4. 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.

    Time frame: 1-2 years for each study site

Secondary outcomes

  1. 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.

    Using a modified framework analysis approach, a team of 3-4 trained research assistants and the two emergency ultrasound fellows led by an implementation science expert will deductively analyze semi-structured interview content based on RE-AIM constructs with open inductive coding for data that does not fit into the framework. The investigators will perform a preliminary rapid qualitative deductive analysis based on audio recordings and meeting notes applied to the RE-AIM dimensions, to determine scope and saturation. Coding and categorization will be conducted with RE-AIM templated coding sheets and transferred to NVivo.

    Time frame: 1-2 years for each study site

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

    Participants will complete a pre-, post-, and 6-month post-training knowledge assessment and technical skill test to assess the educational impact of the cardiac POCUS program, structured using the Ultrasound Competency Assessment Tool (UCAT), which is scored on a Likert scale from 1-5, where a higher score indicates greater competency.

    Time frame: 1-2 years for each study site

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

    To assess the advanced practice provider (APP) 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).

    Time frame: 1-2 years for each study site

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

    To assess APP 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).

    Time frame: 1-2 years for each study site

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

    The investigators will collect data on diagnostic accuracy as compared to radiology studies (from ultrasound expert review, True Positive, True Negative, False Positive, False Negative, or Technically-limited study)

    Time frame: 1-2 years for each study site

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

    Time frame: 1-2 years for each study site

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

    Time frame: 1-2 years for each study site

  8. Aim 2: Impact of the training model on cost-effectiveness

    The investigators will collect pre/post-intervention POCUS revenue data for cost-effectiveness (from hospital billing data, units in dollars).

    Time frame: 1-2 years for each study site

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07159269
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Nov 13, 2025
Primary completion
Dec 31, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jun 3, 2026

Study contacts

Rebecca G Theophanous, MD, MHSc
Contact
rebecca.theophanous@duke.edu
919-681-0196
Abha Singh
Contact
abha.singh@duke.edu
919-668-8700
Rebecca G Theophanous, MD, MHSc
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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