Ultrasound Simulation or Traditional Ultrasound Training for General Practitioners?

NCT07127588 | Recruiting

• 1 other identifier: 262-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare two different educational methods for training general practitioners (GPs) in point-of-care ultrasound. The main question it aims to answer is: \- Does the use of ultrasound phantoms and simulators result in superior post-course ultrasound skills compared to traditional training methods involving healthy volunteers? Researchers will compare a group trained with traditional methods (scanning healthy volunteers) to a group trained using ultrasound phantoms and simulators to see if the different training methods result in different levels of ultrasound proficiency. Participants will:

• Be 24 general practitioners randomized into two groups of 12.
• Receive training in five clinical ultrasound examinations: 1) Aortic abdominal aneurism, 2) gallstones, 3) pleural effusion, 4) hydronephrosis, and 5) free fluid in the abdomen (FAST scan).
• Begin with e-learning, followed by two in-person teaching seminars.
• Train at their clinics between course days: first on healthy volunteers, then on indicated patients.
• Upload scans to an online learning platform and receive feedback from instructors.
• Be assessed after 90 days using the validated Objective Structured Assessment of Ultrasound Skills (OSAUS) tool, with blinded evaluators.

Conditions

Ultrasound Training

Keywords

Point-of-care ultrasound; Clinical ultrasound; Education; General practitioners; Simulation; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean OSAUS sum score across all five POCUS applications (min-max: 7-35)

  Scanning competence is assessed similarly in the two groups by ultrasound expert reviewers blinded to participant allocation. The reviewers will use the OSAUS score, which consists of 7 items. Each item is rated using a Likert Scale with five points (1-5) giving a minimum score of 7 and maximum of 35 for each POCUS application.

  At the third teaching seminar (day 90)

Study Arms (2)

Simulation

EXPERIMENTAL

General practitioners allocated to the intervention arm will participate in the POCUS course with hands-on training on an ultrasound simulator which can portrait both the normal reference and pathology at hands-on teaching seminars.

Other: Simulation based clinical ultrasound education

Healthy volunteers

ACTIVE COMPARATOR

General practitioners allocated to the control arm will participate in the POCUS course with hands-on training on healthy volunteers and pathology presented as still pictures and videos at hands-on teaching seminars.

Other: Traditional ultrasound education

Interventions

Simulation based clinical ultrasound education OTHER

At the two hands-on teaching seminars, GPs in the intervention arm will receive training in five different clinical ultrasound examinations using an ultrasound phantom and an ultrasound simulator (Simbionix U/S Mentor). At the start of the first course day (8 hours), three basic modules will be conducted on the simulator, aimed at training hand-eye coordination and developing fundamental skills in probe movement, enhancing three-dimensional perception, and learning to use the various settings on the ultrasound simulator to achieve optimal imaging. At the first course day, the five clinical ultrasound examinations will be trained through a total of 13 simulation cases. On the second course day (4 hours), the participants will repeat the 13 simulation cases.

Simulation

Traditional ultrasound education OTHER

At the two hands-on teaching seminars, GPs in the control arm will receive training in five different clinical ultrasound examinations as according to an established and validated training program. At the start of the first course day (8 hours), the five clinical ultrasound examinations will be trained using healthy volunteers and still pictures for visualizing pathology. On the second course day (4 hours), the participants will train by repeating the five clinical ultrasound examinations on healthy volunteers.

Healthy volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must be a postgraduate medical doctor specialized in general medicine/family medicine (general practitioner).
• The participant must have access to an ultrasound device during the study period.

You may not qualify if:

• General practitioners who have already participated in a basic point-of-care ultrasound education for general practitioners.
• General practitioners with potential conflicts of interest.
• Individuals with no signed informed consent to participate.

Sponsors & Collaborators

• Aalborg University: lead
• Nordsim: collaborator

Study Sites (1)

NordSim

Aalborg, Denmark

RECRUITING

Central Study Contacts

Julie J Strøm

CONTACT

004520869389; jrjepsen@dcm.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 17, 2025
• Study Start: June 26, 2025
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

DK (1)