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

NCT07402668 — Not applicable, Recruiting, 125 participants, Copenhagen University Hospital, Rigshospitalet

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RegistryNCT07402668
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, other
Enrollment125 (Estimated)
SponsorCopenhagen University Hospital, Rigshospitalet (Other); 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
ConditionsPreterm Birth, Artificial Intelligence (AI) in Diagnosis
InterventionsAI prediction (binary), AI risk estimate (%) (Behavioral)
Datesstart 2026-02-03, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2026-02-11, last updated 2026-07-01
Locations18 sites in Denmark

Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Birth All trials for Artificial Intelligence (AI) in Diagnosis All trials of AI prediction (binary) All trials of AI risk estimate (%)

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
AI predictionExperimentalBehavioral: AI prediction (binary)The participants receive a binary AI prediction (preterm or term birth)
AI risk estimateExperimentalBehavioral: AI risk estimate (%)The participants receive an AI risk estimate of preterm birth (%)
  • AI prediction (binary) (Behavioral): AI decision support based on cervical ultrasound providing a binary classification (preterm birth before 37 weeks or term birth) in addition to standard clinical information.
  • AI risk estimate (%) (Behavioral): AI decision support based on cervical ultrasound providing an estimate of preterm birth risk (%) in addition to standard clinical information.

+Outcome measures

Primary outcomes

  • Clinician diagnostic calibration (accuracy-confidence alignment) after AI exposure. [Immediately after AI exposure during a single questionnaire session (approximately 20 minutes).]: Agreement between post-AI decision correctness (0/1) and post-AI confidence rating (0-10) will be quantified using the Brier score. Confidence will be rescaled to 0-1 and squared differences between confidence and correctness will be averaged across cases to produce a participant-level score. Lower scores indicate better diagnostic calibration. Results will be compared between randomized arms.

Secondary outcomes

  • Helpful switch rate and harmful switch rate. [Baseline (pre-AI) and immediately after AI exposure during a single questionnaire session (approximately 20 minutes).]: Proportion of cases with helpful and harmful switches calculated for each participant and compared between study arms. Helpful switch = incorrect pre-AI decision changing to correct post-AI decision. Harmful switch = correct pre-AI decision changing to incorrect post-AI decision.
  • Change in decision accuracy, confidence, and diagnostic calibration from pre-AI to post-AI. [Baseline (pre-AI) and immediately after AI exposure during a single questionnaire session (approximately 20 minutes).]: Within-participant change from pre-AI to post-AI in decision accuracy (proportion of correct decisions), confidence rating, and diagnostic calibration. Differences will be compared between randomized arms and stratified by AI correctness.
  • Association between self-rated trust in AI and behavioral reliance on AI. [Immediately after AI exposure during a single questionnaire session (approximately 20 minutes).]: Self-rated trust in the AI output will be measured using a numeric rating scale (0-10) after AI exposure for each case. Behavioral reliance will be quantified as the proportion of post-AI decisions concordant with the AI output. The relationship between trust ratings and behavioral reliance, including concordance when the AI is correct and incorrect, will be evaluated at the participant level and compared between randomized arms.
  • Follow-up cervical ultrasound planning. [Baseline (pre-AI) and immediately after AI exposure during a single questionnaire session (approximately 20 minutes).]: Proportion of cases in which clinicians plan an additional cervical ultrasound (yes/no), summarized per participant and compared pre-post AI and between randomized arms.

+Eligibility

Sex: All, accepts healthy volunteers

Inclusion Criteria:

* Medical doctors currently working in or training within the field of obstetrics and gynecology.
* Experience performing transvaginal cervical ultrasound examinations.

Exclusion Criteria:

\- No prior experience performing transvaginal cervical ultrasound examinations.

+Locations (18)

FacilityCityCountryStatus
South Jutland HospitalAabenraaDenmarkRecruiting
Aalborg University Hospital (Aalborg and Thisted)AalborgDenmarkRecruiting
Aarhus University HospitalAarhusDenmarkRecruiting
Copenhagen University Hospital, RigshospitaletCopenhagenDenmarkRecruiting
Esbjerg HospitalEsbjergDenmarkRecruiting
Gødstrup Regional HospitalGødstrupDenmarkRecruiting
Herlev HospitalHerlevDenmarkRecruiting
Copenhagen University Hospital, North ZealandHillerødDenmarkRecruiting
Region Hospital North JutlandHjørringDenmarkRecruiting
Holbæk HospitalHolbækDenmarkRecruiting
Horsens Regional HospitalHorsensDenmarkRecruiting
Hvidovre HospitalHvidovreDenmarkRecruiting
Kolding HospitalKoldingDenmarkRecruiting
Odense University Hospital (Odense and Svendborg)OdenseDenmarkRecruiting
Randers Regional HospitalRandersDenmarkRecruiting
Zealand University Hospital (Roskilde and Nykøbing F.)RoskildeDenmarkRecruiting
Slagelse HospitalSlagelseDenmarkRecruiting
Viborg Regional HospitalViborgDenmarkRecruiting

+Investigators