Point-of-care UltrasoundUS Sim casesNCT06960837
Ultrasound Simulation Case-based Workshop Implementation and Impact Assessment
A study testing ultrasound simulation training case-based workshop during resident sim days in people with Point-of-care Ultrasound and Simulation Training, run by Duke University at 1 site in United States.
Trial summary
This study is a prospective cohort study implementing a point-of-care ultrasound (POCUS) simulation case-based workshop in emergency (EM) physicians at different training levels as an educational and competency-based assessment tool. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Point-of-care Ultrasound, Simulation Training, Medical Education in Emergency Ultrasound
- What is being tested?
- ultrasound simulation training case-based workshop during resident sim days
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 31 Dec 2026
- 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
- Emergency medicine physicians
Who cannot join
- Emergency medicine nurses
- Emergency medicine technicians
- Advanced practice providers (APPs)
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, 27703
Abha Singh, 919-668-8700, as609@duke.edu
Rebecca G Theophanous, MD, MHSc
About this study
This study is a prospective cohort study implementing a point-of-care ultrasound (POCUS) simulation case-based workshop in emergency (EM) physicians at different training levels as an educational and competency-based assessment tool. The investigators incorporate elements of Miller's pyramid (second and third levels of "knows how" and "shows how") and the latter part of Kern's six step model framework for curriculum development (intervention implementation and student assessment, program evaluation, and feedback). The investigators will compare pre-/post-workshop knowledge and post-OSCE (Objective Structured Clinical Exam) technical skills scores. The investigators will also collect demographic data on baseline POCUS scans completed, training level, interest in ultrasound fellowship, monthly performed clinical POCUS scans, etc. The standardized simulation cases for EM POCUS training can then be generalized for use at any program globally to improve clinical training and patient care.
- Being tested
- ultrasound simulation training case-based workshop during resident sim days
- Keywords
- point-of-care ultrasound, simulation training, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound simulation training case-based workshop during resident sim daysBehavioural
Using the CAE Vimedix ultrasound simulator or standardized patient, a patient stem will be read or video shown to an individual participant. The participant will have 10 minutes to discuss the scenario and scan the simulator/patient. Participants will verbalize their findings and receive additional information, including diagnostic tests or point-of-care ultrasound (POCUS) videos, as they proceed through the case. They will be scored using a standardized rubric. For Objective Structured Clinical Exam (OSCE) testing, two independent raters, both with ultrasound fellowship training, one known to the participants and one unknown to the participants, will observe and rate the participant on a simulated POCUS case using the already published OSCE tool. The rater will read a brief standardized stem, and the participant will have 10 minutes to complete the station.
| Study group | Role | What they receive |
|---|---|---|
| Emergency (EM) Physicians | Experimental | EM physicians will participate in a standardized simulation encounter during simulation days, resident conference, or faculty development sessions. Receives: Behavioral: ultrasound simulation training case-based workshop during resident sim days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge exam score
Assessing the impact of the POCUS (point-of-care ultrasound) simulation workshop to improve training for clinical diagnostic thought processes.
Measured: Baseline to 12 months
Secondary outcomes (3)
Ultrasound Competency Assessment Tool (UCAT) score
Assessing the impact of the POCUS (point-of-care ultrasound) simulation workshop to improve training for clinical diagnostic thought processes.
Measured: 12 months
Number of POCUS (point-of-care ultrasound) exams performed per participant
Collected via electronic health records.
Measured: 12 months
Change in quality assurance score
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start6 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point-of-care UltrasoundStudies 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
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT06960837
- Sponsor's protocol ID
- Pro00117455
- Acronym
- US Sim cases
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- 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
- Ultrasound Simulation Case-based Workshop Implementation and Impact Assessment
- ClinicalTrials.gov ID
- NCT06960837
- Acronym / sponsor ID
- US Sim cases / Pro00117455
- Keywords
- point-of-care ultrasound, simulation training, medical education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 May 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.
This study is a prospective cohort study implementing a point-of-care ultrasound (POCUS) simulation case-based workshop in emergency (EM) physicians at different training levels as an educational and competency-based assessment tool. The investigators incorporate elements of Miller's pyramid (second and third levels of "knows how" and "shows how") and the latter part of Kern's six step model framework for curriculum development (intervention implementation and student assessment, program evaluation, and feedback). The investigators will compare pre-/post-workshop knowledge and post-OSCE (Objective Structured Clinical Exam) technical skills scores. The investigators will also collect demographic data on baseline POCUS scans completed, training level, interest in ultrasound fellowship, monthly performed clinical POCUS scans, etc. The standardized simulation cases for EM POCUS training can then be generalized for use at any program globally to improve clinical training and patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency (EM) Physicians | Experimental | Behavioral: ultrasound simulation training case-based workshop during resident sim daysEM physicians will participate in a standardized simulation encounter during simulation days, resident conference, or faculty development sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency medicine physicians
Key exclusion criteria (3 listed)
- Emergency medicine nurses
- Emergency medicine technicians
- Advanced practice providers (APPs)
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 |
|---|---|---|
| ultrasound simulation training case-based workshop during resident sim daysUsing the CAE Vimedix ultrasound simulator or standardized patient, a patient stem will be read or video shown to an individual participant. The participant will have 10 minutes to discuss the scenario and scan the simulator/patient. Participants will verbalize their findings and receive additional information, including diagnostic tests or point-of-care ultrasound (POCUS) videos, as they proceed through the case. They will be scored using a standardized rubric. For Objective Structured Clinical Exam (OSCE) testing, two independent raters, both with ultrasound fellowship training, one known to the participants and one unknown to the participants, will observe and rate the participant on a simulated POCUS case using the already published OSCE tool. The rater will read a brief standardized stem, and the participant will have 10 minutes to complete the station. | Behavioural | Emergency (EM) Physicians |
Primary outcome
Change in knowledge exam score
Time frame: Baseline to 12 months
Assessing the impact of the POCUS (point-of-care ultrasound) simulation workshop to improve training for clinical diagnostic thought processes.
3 secondary outcomes
Ultrasound Competency Assessment Tool (UCAT) score
Time frame: 12 months
Number of POCUS (point-of-care ultrasound) exams performed per participant
Time frame: 12 months
Change in quality assurance score
Time frame: Baseline to 12 months
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 ultrasound simulation training case-based workshop during resident sim days in people with Point-of-care Ultrasound and Simulation Training, 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 3 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 (919-681-6091, rebecca.theophanous@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge exam score (time frame: Baseline to 12 months). 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.