Cardiovascular Disease AcuteNCT07159269
Cardiac point-of Care Ultrasound Training Pathway for Emergency Department Advanced Practice Providers
A study testing Cardiac point-of-care ultrasound (POCUS) training and clinical pathway in people with Cardiovascular Disease Acute and Emergency Department Patient, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Acute, Emergency Department Patient, Heart Failure Acute
- What is being tested?
- Cardiac point-of-care ultrasound (POCUS) training and clinical pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- non-APPs such as physicians, nurses, or other clinical staff
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27705
Rebecca G Theophanous, MD, MHSc, 919-681-0196, rebecca.theophanous@duke.edu
About this study
Official title: Cardiac Point-of-care Ultrasound Clinical Training Pathway Implementation and Impact Assessment for Advanced Practice Providers in the Emergency Department
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.
- Conditions
- Cardiovascular Disease Acute, Emergency Department Patient, Heart Failure Acute, Pulmonary Embolism (Diagnosis), Point of Care Ultrasound (POCUS), Cardiac Tamponade
- Being tested
- Cardiac point-of-care ultrasound (POCUS) training and clinical pathway
- Keywords
- point of care ultrasound, focused cardiac ultrasound, advanced practice provider training, medical education, implementation science
- Medical subject headings
- Pulmonary Embolism, Disease, Cardiac Tamponade, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac point-of-care ultrasound (POCUS) training and clinical pathwayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Practice Provider (APP) Cohort | Experimental | Advanced Practice Providers (APPs) are nonphysicians essential to the emergency department workforce, especially in rural and community hospitals. Receives: Behavioral: Cardiac point-of-care ultrasound (POCUS) training and clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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)
Measured: 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 - 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).
Measured: 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 - 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).
Measured: 1-2 years for each study site
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).
Measured: 1-2 years for each study site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start13 Nov 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease AcuteStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca G Theophanous, MD, MHSc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159269
- Sponsor's protocol ID
- Pro00118464
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Point-of-care Ultrasound Clinical Training Pathway Implementation and Impact Assessment for Advanced Practice Providers in the Emergency Department
- ClinicalTrials.gov ID
- NCT07159269
- Acronym / sponsor ID
- Pro00118464
- Conditions
- Cardiovascular Disease Acute, Emergency Department Patient, Heart Failure Acute, Pulmonary Embolism (Diagnosis), Point of Care Ultrasound (POCUS), Cardiac Tamponade
- Keywords
- point of care ultrasound, focused cardiac ultrasound, advanced practice provider training, medical education, implementation science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Advanced Practice Provider (APP) Cohort | Experimental | Behavioral: Cardiac point-of-care ultrasound (POCUS) training and clinical pathwayAdvanced Practice Providers (APPs) are nonphysicians essential to the emergency department workforce, especially in rural and community hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- non-APPs such as physicians, nurses, or other clinical staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac point-of-care ultrasound (POCUS) training and clinical pathwayParticipants 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. | Behavioural | Advanced Practice Provider (APP) Cohort |
Primary outcome
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.
Time frame: 1-2 years for each study site
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.
Aim 1: Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)
Time frame: 1-2 years for each study site
The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability.
Aim 1: Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM)
Time frame: 1-2 years for each study site
The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
Aim 1: Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool
Time frame: 1-2 years for each study site
The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
8 secondary outcomes
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 - time to initial cardiology consult
Time frame: 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 - emergency department length-of-stay
Time frame: 1-2 years for each study site
Aim 2: Impact of the training model on cost-effectiveness
Time frame: 1-2 years for each study site
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca G Theophanous, MD, MHSc principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac point-of-care ultrasound (POCUS) training and clinical pathway in people with Cardiovascular Disease Acute and Emergency Department Patient, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca G Theophanous, MD, MHSc (919-681-0196, rebecca.theophanous@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1-2 years for each study site). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.