An interventional study of GPT-4-based virtual patient training and Self-study with printed materials in Medical Education and Head Injury, Minor, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other
This randomized pilot study evaluated whether training with a GPT-4-based virtual patient chat platform (Med2Lab) helps physicians learn the Pediatric Emergency Care Applied Research Network (PECARN) head CT rules, compared with conventional self-study. Physicians with less than 5 years of clinical experience received a short lecture on the PECARN rules and were randomly assigned to 1 hour of self-study with printed materials or 1 hour of history-taking practice with six GPT-4 virtual patients representing pediatric head trauma cases. Knowledge of the PECARN rules, clinical decision-making, history-taking and communication skills, satisfaction with the training, and usability of the platform were assessed.
Background: Generative AI chatbots such as GPT-4 can role-play patients from an educator-written prompt, allowing learners to practice history-taking as if with a real patient. The PECARN head CT rules guide CT decisions in children with minor head trauma and require structured history-taking.
Objective: To compare GPT-4-based virtual patient training with conventional self-study for learning the PECARN head CT rules, and to examine whether the platform improves history-taking and communication skills.
Methods: Prospective, randomized, parallel-group pilot trial at Samsung Medical Center, Seoul, Korea. Licensed physicians with no experience as an emergency department attending physician or with less than 5 years of clinical experience were recruited through the hospital intranet and online physician communities. After written informed consent, participants drew a slip from a box to be allocated 1:1 to the control or virtual patient group. All participants completed a baseline knowledge checklist (10 short-answer and 10 case-based items) and a mini-clinical evaluation exercise (mini-CEX) on pediatric head trauma cases, including a clinical decision assessment of PECARN risk category and need for head CT. All then received a 5-minute lecture on the PECARN rules. The control group studied for up to 1 hour with the printed PECARN publication, a summary, and six training cases in print. The virtual patient group practiced for up to 1 hour on the Med2Lab platform, interviewing six GPT-4 virtual patients built on PECARN scenarios, with case review by a virtual instructor after each case. The knowledge checklist and a mini-CEX on a new case were repeated after training, followed by questionnaires on confidence and satisfaction; the virtual patient group also completed the System Usability Scale. The planned sample was 40 participants (45 allowing for dropout).
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 20 is below the median of 87 across 133 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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After a 5-minute lecture on the PECARN head CT rules, participants practiced history-taking for up to 1 hour on the Med2Lab platform with six GPT-4-based virtual patients representing pediatric head trauma cases, with case review by a virtual instructor after each case.
Behavioral: GPT-4-based virtual patient training
After the same 5-minute lecture on the PECARN head CT rules, participants studied for up to 1 hour with printed materials: the original PECARN publication, a summary, and the same six training cases in printed form.
Behavioral: Self-study with printed materials
Free-text history-taking practice with six GPT-4-based virtual patients on the Med2Lab platform (up to 1 hour). Each virtual patient is defined by an educator-written prompt describing a PECARN-based pediatric head trauma scenario and behavioral rules; after each case a virtual instructor reviews the case and the learner's clinical reasoning.
Self-directed study for up to 1 hour with printed materials: the original PECARN head injury prediction rule publication, a summary of the rules, and the same six pediatric head trauma training cases in printed form.
Change in Mini-Clinical Evaluation Exercise (Mini-CEX) Score
History-taking and clinical performance on a standardized pediatric head trauma case, rated by two assessors with the Royal Brisbane and Women's Hospital Emergency Department Mini-CEX form; the same assessors rate before and after training. Difference in change between groups.
Time frame: Baseline and immediately after the training session (same day)
Change in Communication Skill Score
Communication skills during the Mini-CEX case, rated with the communication skills assessment items (LCSAS) by the same assessors before and after training. Difference in change between groups.
Time frame: Baseline and immediately after the training session (same day)
Change in PECARN Knowledge Checklist Score
Knowledge checklist on the PECARN head CT rules consisting of 10 short-answer items and 10 case-based decision items, administered before and after training. Difference in change between groups.
Time frame: Baseline and immediately after the training session (same day)
Change in Clinical Decision Accuracy
Correct determination of the PECARN risk category and of the need for head CT on the standardized pediatric head trauma case (clinical decision assessment), before and after training. Difference in change between groups.
Time frame: Baseline and immediately after the training session (same day)
Satisfaction With the Training
Post-training questionnaire on confidence and satisfaction with the education, completed by both groups.
Time frame: Immediately after the training session (same day)
System Usability Scale (SUS) Score
Usability of the Med2Lab virtual patient platform measured with the 10-item System Usability Scale (score 0-100; higher scores indicate better usability), virtual patient group only.
Time frame: Immediately after the training session (same day)
Plan to share: No — Individual participant data are not shared because participant consent and IRB approval did not cover data release; de-identified summary data are available from the investigators on reasonable request.
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in Nov 2025, 23 months.
Of 50 non-industry interventional studies with no phase under Craniocerebral Trauma, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's 23 months is below that.
Counting every sponsor, half of 51 studies reached it within 26 months; a quarter within 11 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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