Viewing Study NCT07179861


Ignite Creation Date: 2025-12-24 @ 11:47 AM
Ignite Modification Date: 2025-12-30 @ 3:28 PM
Study NCT ID: NCT07179861
Status: COMPLETED
Last Update Posted: 2025-09-23
First Post: 2025-09-11
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Comparing Artificial Intelligence and Physicians: A Vignette-Based Study in Pediatric Clinical Decision-Making
Sponsor: Haseki Training and Research Hospital
Organization:

Study Overview

Official Title: A Prospective, Cross-Sectional, Vignette-Based Observational Study Comparing Clinical Decision-Making Performance of Pediatriciansand AI Models
Status: COMPLETED
Status Verified Date: 2025-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study evaluates how well anonymized artificial-intelligence (AI) tools perform on standardized pediatric case vignettes and whether showing AI suggestions can improve clinicians' answers. About 30 board-certified/eligible pediatric specialists at a single hospital complete a one-time session. Participants are randomized to two groups. Group A (n≈15): physicians answer each vignette once. Group B (n≈15): physicians answer and rate confidence (1-10), then review anonymized suggestions from five different AI tools (tool names not shown) and may keep or change their answer; changes and confidence are recorded.

Primary focus: measure AI performance (diagnostic accuracy, medication-dosing accuracy, interpretation accuracy) overall and by difficulty tier, and record AI response time. Secondary focus: quantify how AI suggestions affect human performance (change in accuracy, direction of change, confidence shift, and time). No patients or biospecimens are involved; risks are minimal (time and possible discomfort with performance review). Findings may inform safe, evidence-based ways to use AI alongside clinicians in pediatrics.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: