Ultrasound Simulation or Traditional Ultrasound Training for General Practitioners?

NCT ID: NCT07127588

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-26
• Study Completion Date: 2025-12-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Simulation

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.

Group Type: EXPERIMENTAL

Simulation based clinical ultrasound education

Intervention Type: 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.

Healthy volunteers

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.

Group Type: ACTIVE_COMPARATOR

Traditional ultrasound education

Intervention Type: 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.

Interventions

Simulation based clinical ultrasound education

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.

Intervention Type: OTHER

Traditional ultrasound education

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nordsim

UNKNOWN

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Julie Jepsen Strøm

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NordSim

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Julie J Strøm

Role: CONTACT

jrjepsen@dcm.aau.dk

004520869389

Other Identifiers

262-1

Identifier Type: -

Identifier Source: org_study_id