Clinical trial Recruiting at 1 site Interventional Ages 18 and up

AI-guided risk alerts to help doctors spot iron deficiency

Official title: Evaluation of the Clinical Impact of Machine Learning-Based Risk Classification Using Blood Analysis on Iron Deficiency Detection

Run by China Medical University Hospital · NCT07394088 · Data updated 2026-11-12

This trial tests whether an AI risk alert shown to clinicians after a CBC helps them detect iron deficiency more often in adult outpatients.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment2196 (estimated)
SponsorChina Medical University Hospital
Academic / other
Locations1 site (Taichung)
StatusRecruiting
StartedApril 1, 2026
Main results expectedDecember 31, 2026
Study endsMarch 2027
Registry record updatedMay 26, 2026
Trial IDNCT07394088 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) receiving outpatient care in internal medicine, family medicine, or hematology/oncology at CMUH who have a CBC performed as part of routine care.

Probably not a fit

Patients in whom iron deficiency is not present or where the AI alert does not change clinical decisions may not experience direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, pragmatic randomized trial at China Medical University Hospital in Taiwan. The study integrates a machine learning risk notification into the electronic health record to alert physicians after CBC results are available. Participants are adult outpatients in internal medicine, family medicine, and hematology/oncology clinics, with randomization occurring automatically within routine care. The trial examines whether the AI display changes physician testing and diagnostic behavior, including ferritin testing rates and the diagnostic yield of those tests, in real-world outpatient practice.

Why it matters

Potential benefit: If successful, clinicians may detect iron deficiency more reliably and efficiently, potentially leading to earlier treatment for patients who need it.

How similar studies have gone: Prior pragmatic, AI-based decision support trials have shown potential to influence diagnostic testing, but this specific iron deficiency alert approach is relatively novel in this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Adults aged 18 years or older.
2. Patients attending outpatient clinics of participating departments including 2.1. Internal Medicine, 2.2 Family Medicine 2.3. Hematology/Oncology
3. Completion of a routine complete blood count (CBC) as part of usual clinical care during the outpatient encounter.
4. Availability of the CBC report in the institutional laboratory information system, allowing sufficient data for analysis.

Exclusion Criteria:

1. Encounters with missing or incomplete key identifiers (e.g., patient identification number, ) that prevent determination of exposure status (AI information displayed vs not displayed) or assessment of outcomes within the defined follow-up period.
2. Encounters without a valid department code required by the information system to trigger the randomization mechanism and AI risk display.
3. Encounters with incomplete or missing laboratory data required to activate the AI system.
4. Repeated CBC encounters from the same patient during the study period, if applicable; only the first eligible encounter will be included to avoid duplication.

Where it's running

  • China Medical University Hospital
    Taichung, Taiwan
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.