Clinical Trial

Does AI Make Clinicians More Appropriately Confident? A Randomized Study in Preterm Birth Prediction

Recruiting
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Summary
The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and gynecology when assessing the risk of spontaneous preterm birth using clinical case vignettes with cervical ultrasound images. The study specifically compares two AI presentation formats: a binary classification (preterm vs term birth) and an individualized risk estimate of preterm birth. The main questions it aims to answer are: * Which AI presentation format leads to better alignment between clinicians' confidence and decision accuracy (diagnostic calibration)? * Do different AI presentation formats lead to helpful or harmful changes in clinical decisions? Participants will complete an online questionnaire in which they review clinical cases, make diagnostic and management decisions, rate their diagnostic confidence before and after seeing the AI output, and report their trust in the AI.
Protocol Amendment History 5 changes
notable Trial sites expanded: 7 -> 18 locations 2026-07-02
notable Primary completion pushed: 2026-06 -> 2026-07 2026-07-02
minor Completion pushed: 2026-06 -> 2026-07 2026-07-02
notable Primary completion pushed: 2026-03 -> 2026-06 2026-05-06
minor Completion pushed: 2026-03 -> 2026-06 2026-05-06
Trial Details
NCT Number NCT07402668
Lead Sponsor Rigshospitalet, Denmark
Collaborators: Technical University of Denmark, The Foundation of 17.12.1981, Department of Computer Science, University of Copenhagen, Denmark, Copenhagen Academy for Medical Education and Simulation
Conditions Preterm Birth, Artificial Intelligence (AI) in Diagnosis
Enrollment 125 participants
Start Date 2026-02-03
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-01