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NCT Number: NCT06846229

AI-Assisted Medical Decision-Making

The study builds and applies an AI model to help doctors predict patient diagnoses and outcomes, such as survival or hospital stay. Real-time, multimodal data (labs, vital signs, history, imaging) from hospital records will be used. Patients will be tracked to compare the AI's performance with standard care. The goal is to improve diagnosis and treatment accuracy in a real-world, prospective study.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

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About this study

This study aims to build and apply an artificial intelligence (AI) model to assist doctors in predicting patient diagnoses and outcomes, such as survival or hospital stay length. Patients will be enrolled across the hospital, and real-time, multimodal health data-including lab results, vital signs, medical history, and imaging-from electronic health records will be used. The study will follow participants to evaluate the AI model's performance against standard practice. The goal is to improve the accuracy and speed of diagnoses and treatments, enhancing patient care. This prospective study tests the model in real-world hospital settings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted to any department of the hospital (e.g., ICU, general wards, emergency, outpatient services) during the study period.
  • Patients with available real-time electronic health record (EHR) data, including at least two of the following: laboratory results, vital signs, medical history, and imaging data.

Exclusion criteria

Patients currently enrolled in another clinical trial that could interfere with data collection or outcomes of this study.

Treatment and study plan

AI-associated strategy

Other

The intervention in this study involves an AI system that leverages multimodal data fusion to support the clinical decision-making and evaluation of diseases. Patients in this cohort will undergo standard examinations, with clinical decisions guided by the recommendations generated by the AI system.

Primary outcomes

  1. Area Under the Curve (AUC)

    Time frame: 1 year

    AUC of the ROC curve, used to quantify diagnostic accuracy. No unit (a ratio or percentage, typically expressed as a number between 0 and 1).

  2. Overall Hospital Resource Utilization Improvement

    Time frame: 1 year

    The percentage reduction in overall hospital resource use (e.g., bed days, ICU admissions, diagnostic tests) attributed to AI-assisted decision-making, expressed as a percentage.

  3. Population-Level Diagnostic Accuracy Enhancement

    Time frame: 1 year

    The overall improvement in diagnostic accuracy across all hospital patients (e.g., percentage of correct diagnoses or reduction in misdiagnoses) facilitated by the AI model, expressed as a percentage or ratio.

  4. System-Wide Reduction in Adverse Event Rates

    Time frame: 1 year

    The percentage reduction in major adverse events (e.g., mortality, severe complications, or prolonged stays) across all hospital patients due to AI-assisted decision-making, expressed as a percentage.

Secondary outcomes

  1. Overall Improvement in Hospital Patient Outcomes

    Time frame: 1 year

    The aggregate improvement in key patient outcomes (e.g., mortality, morbidity, recovery rates) across the entire hospital population due to AI-assisted decision-making, expressed as a composite score or percentage.

  2. Enhancement of Healthcare System Efficiency

    Time frame: 1 year

    he overall improvement in hospital operational efficiency (e.g., reduced wait times, optimized resource allocation, decreased staff workload) attributed to the AI model, expressed as a percentage or qualitative rating.

  3. Population Health Impact Score

    Time frame: 1 year

    A composite score reflecting the AI model's effect on population health within the hospital's catchment area (e.g., reduced disease burden, improved chronic disease management), expressed as a standardized index or percentage change.

  4. Long-Term Public Health Benefit Index

    Time frame: 1 year

    A composite index measuring the AI model's long-term contribution to public health (e.g., reduced disease prevalence, improved life expectancy), expressed as a standardized score or percentage improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Liu, MD

CONTACT

[email protected]

+86 13810512704

Sponsors and collaborators

Lead sponsor

The Eye Hospital of Wenzhou Medical University

Other

Registry information

Official study title

A Cohort Study to Evaluate an Artificial Intelligence Model for Assisting Medical Decision-Making Using Real-Time Hospital-Wide Electronic Health Record Data

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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