Actively Recruiting
Evaluation of the Clinical Impact of Machine Learning-Based Risk Classification Using Blood Analysis on Iron Deficiency Detection
Led by China Medical University Hospital · Updated on 2026-05-26
2196
Participants Needed
1
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether an AI-based risk notification system integrated into routine clinical care can improve the detection of iron deficiency in adults attending Internal Medicine, Family Medicine, and Hematology/Oncology clinics at China Medical University Hospital in Taiwan. This pragmatic randomized controlled trial aims to see if displaying AI-generated risk classifications to physicians affects iron deficiency detection rates, ordering of ferritin tests, and diagnostic efficiency, comparing outcomes between AI-assisted and standard care groups. The study involves two groups: the Prompt Group, where physicians see AI-generated risk hints categorizing patients as high or low risk for iron deficiency, and the Control Group, where physicians receive standard lab results without AI risk information. For high-risk patients in the Prompt Group, the system checks for recent iron testing and suggests consideration if none was done. The AI tool supports clinical decisions but does not mandate testing or treatment. Randomization occurs automatically after routine complete blood count (CBC) results become available. Participants undergo no additional procedures beyond usual outpatient care and routine CBC testing ordered by their doctors. The AI analyzes existing CBC data within the hospital system without extra patient input. Researchers will monitor iron deficiency detection rates overall and among patients with and without anemia, ferritin test ordering rates, diagnostic yield of ferritin testing, and cost-effectiveness. All data handling complies with institutional privacy policies, and participation lasts during routine outpatient visits without extra visits or tests.
CONDITIONS
Brief Title
Assessing Clinical Impact of AI for Iron Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients attending outpatient clinics in Internal Medicine, Family Medicine, or Hematology/Oncology
- Completion of a routine complete blood count (CBC) as part of usual clinical care during the outpatient visit
- Availability of CBC report in the hospital's laboratory information system for analysis
You will not qualify if you...
- Encounters with missing or incomplete key identification information preventing outcome assessment
- Encounters without a valid department code needed for randomization and AI risk display
- Encounters with incomplete or missing laboratory data required for AI system activation
- Repeat CBC encounters from the same patient during the study period; only the first eligible encounter is included
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (outpatient)
Duration - Ongoing during outpatient visit
Participants are observed during routine outpatient care where a complete blood count (CBC) test is performed as part of usual clinical practice. The AI system provides risk information to physicians for decision support without requiring additional tests or procedures.
1 outpatient visit during which CBC is performed
Duration - Up to 1 month
Within 1 month after the CBC report, participants may undergo iron-related laboratory testing if prompted by the AI risk information and clinical decision. This period is used to assess iron deficiency detection and related diagnostic behaviors.
Follow-up assessments as part of routine care within 1 month
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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