Assessing Clinical Impact of AI for Iron Deficiency

The goal of this clinical trial is to evaluate whether an AI-based risk notification system integrated into routine clinical care can improve the clinical detection of iron deficiency in adult patients attending Internal Medicine, Family Medicine, and Hematology/Oncology clinics at China Medical University Hospital in Taiwan. The main questions this study aims to answer are: 1. Does displaying AI-generated iron deficiency risk classification to physicians increase the overall detection rate of iron deficiency at the population level? 2. Does the AI-based risk notification influence physicians' diagnostic behavior by increasing the rate at which ferritin testing is ordered specifically for suspected iron deficiency? 3. Among ferritin tests ordered for suspected iron deficiency, does the diagnostic yield (positivity rate) remain appropriate, reflecting efficient use of testing resources? 4. Are the effects of the AI-assisted intervention consistent among patients with anemia and without anemia? Comparison Groups Researchers will compare clinical encounters in which physicians receive AI-generated iron deficiency risk information (the Prompt Group) with encounters in which physicians receive standard laboratory results without AI risk display (the Control Group). The comparison focuses on differences in iron deficiency detection, ferritin ordering behavior for suspected iron deficiency, and diagnostic yield. What Participants Will Experience 1. No Additional Procedures: As this is a pragmatic study embedded in routine clinical care, participants will not undergo any additional blood draws, invasive procedures, or clinic visits beyond standard care. 2. Routine Care Only: Patients attend their scheduled outpatient visits and receive complete blood count (CBC) testing as ordered by their treating physician, independent of study participation. 3. Background Data Integration: The AI system operates within the hospital's information system, analyzing routinely collected CBC data after results become available. No additional data entry or action is required from patients. 4. Physician Autonomy Preserved: The AI provides a non-mandatory risk classification as decision support. For patients identified as high risk, the system may display an informational prompt suggesting consideration of iron-related testing if no recent testing is found. All diagnostic and management decisions remain entirely at the discretion of the treating physician.

NCT Number	NCT07394088
Lead Sponsor	China Medical University Hospital
Conditions	Iron Deficiency, Iron Deficiency Anemias
Enrollment	2,196 participants
Start Date	2026-04-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-05-26