NCT06960837

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration 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 Progress64%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 6, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 29, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

point-of-care ultrasoundsimulation trainingmedical education

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 12 months

Secondary Outcomes (3)

  • Ultrasound Competency Assessment Tool (UCAT) score

    12 months

  • Number of POCUS (point-of-care ultrasound) exams performed per participant

    12 months

  • Change in quality assurance score

    Baseline to 12 months

Study Arms (1)

Emergency (EM) Physicians

EXPERIMENTAL

EM physicians will participate in a standardized simulation encounter during simulation days, resident conference, or faculty development sessions.

Behavioral: ultrasound simulation training case-based workshop during resident sim days

Interventions

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.

Emergency (EM) Physicians

Eligibility Criteria

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

You may qualify if:

  • Emergency medicine physicians

You may not qualify if:

  • Emergency medicine nurses
  • Emergency medicine technicians
  • Advanced practice providers (APPs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27703, United States

RECRUITING

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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations