Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07394088

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

On this page

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (outpatient)

Monitoring

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

Follow-up

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

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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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