- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07679698
Self-Directed Learning for Pulmonary Ultrasound Education
"Scaling Up Ultrasound Education Without Scaling Up Tutors: A Randomized Controlled Equivalence Trial of Self-Directed Learning for Pulmonary Pathology Recognition"
This study compared two ways of teaching medical students how to recognize lung conditions using ultrasound images.
All participants were third-year medical students taking part in a structured ultrasound training session at the University of Turin. Students were randomly assigned to one of two groups. One group learned lung ultrasound pathology recognition with direct guidance from a tutor. The other group used a self-directed digital learning tool called MEDQUIZ, which allowed students to review clinical cases and ultrasound videos independently.
The main goal of the study was to determine whether self-directed learning was equivalent to tutor-guided instruction for recognizing pulmonary ultrasound findings. Students completed ultrasound image-based assessments before and after the training. The assessments evaluated their ability to recognize anatomical structures, distinguish normal from abnormal findings, and identify specific lung conditions such as pneumonia, pleural effusion, interstitial syndrome, and pneumothorax.
The study also evaluated student satisfaction with the learning experience.
Study Overview
Status
Intervention / Treatment
Detailed Description
This was a single-center, randomized, controlled equivalence trial conducted at the SimTO Advanced Medical Simulation Center, University of Turin, Italy. The study included third-year medical students enrolled in the curricular "Approach to Ultrasound" internship.
Before the in-person training session, all students completed online instructional materials on thoracic and abdominal ultrasound. During the internship, students participated in a structured two-hour ultrasound training session composed of four 30-minute stations. The stations included hands-on scanning of healthy volunteers and case-based pathology recognition activities.
At the thoracic pathology station, students were randomly assigned to either tutor-guided learning or self-directed learning. In the tutor-guided group, students worked through pulmonary ultrasound cases with direct supervision, clinical reasoning guidance, and feedback from a tutor. In the self-directed learning group, students used MEDQUIZ, a purpose-built digital learning tool that presented clinical cases, patient information, and lung ultrasound video clips in an interactive format.
The primary outcomes were based on pre-training and post-training assessments using ultrasound video cases. Students were assessed on three levels of competency: recognition of the anatomical structure shown in the ultrasound clip, classification of the finding as physiological or pathological, and identification of the specific pulmonary condition when a pathological finding was present. An overall case resolution score was also calculated.
Secondary outcomes included student satisfaction with the simulation-based learning experience, assessed at the end of the internship.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Italy
-
Turin, Italy, Italy, 10126
- Advanced Medical Simulation Center- SimTO, School of Medicine, Turin, Italy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Third-year medical students enrolled in the "Approach to Ultrasound" curricular internship at the University of Turin
- Limited or no prior ultrasound experience
- No previous formal specialized ultrasound training
- Provision of informed consent for data collection
Exclusion Criteria:
- Inability to attend the complete ultrasound training session and both assessment sessions
- Physical or medical conditions limiting participation in hands-on ultrasound practice
- Refusal to provide informed consent for data collection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Tutor-Guided Learning
Participants assigned to this arm completed the thoracic pathology recognition station with direct tutor guidance.
During the session, students reviewed pulmonary ultrasound cases through structured case-based learning, received real-time clinical reasoning guidance, and were provided with immediate corrective feedback by a trained tutor.
All other components of the ultrasound internship were identical to those completed by the self-directed learning group.
|
Participants completed the thoracic pathology recognition station with direct tutor guidance.
During the 30-minute station, students reviewed pulmonary ultrasound cases through structured case-based learning, received real-time clinical reasoning guidance, and were provided with immediate corrective feedback by a trained tutor.
|
|
Experimental: Self-Directed Learning
Participants assigned to this arm completed the thoracic pathology recognition station using MEDQUIZ, a purpose-built self-directed digital learning tool.
Students independently reviewed clinical cases, patient information, and pulmonary ultrasound video clips without structured tutor guidance.
The tool included learning materials that remained available during the session.
All other components of the ultrasound internship were identical to those completed by the tutor-guided learning group.
|
Participants used MEDQUIZ, a purpose-built digital learning tool, to complete the thoracic pathology recognition station independently.
The tool presented clinical cases, patient information, learning materials, and pulmonary ultrasound video clips.
Students reviewed the cases and answered independently without structured tutor guidance during the 30-minute station.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anatomical Structure Recognition Accuracy
Time Frame: Immediately before and immediately after the 3-hour ultrasound training session
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Percentage of pulmonary ultrasound cases in which participants correctly identified the anatomical structure shown in the ultrasound video clip.
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Immediately before and immediately after the 3-hour ultrasound training session
|
|
Physiological Versus Pathological Discrimination Accuracy
Time Frame: Immediately before and immediately after the 3-hour ultrasound training session
|
Percentage of pulmonary ultrasound cases in which participants correctly classified the ultrasound finding as physiological or pathological.
|
Immediately before and immediately after the 3-hour ultrasound training session
|
|
Pulmonary Pathology Identification Accuracy
Time Frame: Immediately before and immediately after the 3-hour ultrasound training session
|
Percentage of pathological pulmonary ultrasound cases in which participants correctly identified the specific pulmonary condition shown in the ultrasound video clip, including pneumonia or consolidation, interstitial syndrome, pleural effusion, or pneumothorax.
|
Immediately before and immediately after the 3-hour ultrasound training session
|
|
Overall Pulmonary Ultrasound Case Resolution Score
Time Frame: Immediately before and immediately after the 3-hour ultrasound training session
|
Percentage of pulmonary ultrasound cases correctly resolved with the maximum score.
A case was considered correctly resolved when the participant correctly identified the anatomical structure, correctly classified the finding as physiological or pathological, and, where applicable, correctly identified the specific pulmonary pathology.
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Immediately before and immediately after the 3-hour ultrasound training session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Satisfaction With the Simulation Experience
Time Frame: Immediately after the 3-hour ultrasound training session
|
Student satisfaction with the ultrasound training experience will be assessed after the session using the Italian version of the Satisfaction with Simulation Experience scale.
This scale includes 18 items rated on a 5-point Likert scale, from 1 to 5. The total score ranges from 18 to 90, with higher scores indicating greater satisfaction with the simulation-based learning experience.
Three subscale scores will also be calculated: Debriefing and Reflection, ranging from 9 to 45; Clinical Reasoning, ranging from 5 to 25; and Clinical Learning, ranging from 4 to 20.
For all subscales, higher scores indicate a better outcome, corresponding to greater satisfaction in the specific domain.
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Immediately after the 3-hour ultrasound training session
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alberto Milan, PhD, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 219865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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