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AI-Assisted Medical Decision-Making

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06846229
Enrollment
50000000
Registered
2025-02-26
Start date
2025-02-24
Completion date
2026-06-30
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Real-world Study

Keywords

diagnosis, prediction, AI, outcome

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Patients admitted to any department of the hospital (e.g., ICU, general wards, emergency, outpatient services) during the study period. 2. 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.

Design outcomes

Primary

MeasureTime frameDescription
System-Wide Reduction in Adverse Event Rates1 yearThe 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.
Area Under the Curve (AUC)1 yearAUC of the ROC curve, used to quantify diagnostic accuracy. No unit (a ratio or percentage, typically expressed as a number between 0 and 1).
Overall Hospital Resource Utilization Improvement1 yearThe 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.
Population-Level Diagnostic Accuracy Enhancement1 yearThe 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.

Secondary

MeasureTime frameDescription
Overall Improvement in Hospital Patient Outcomes1 yearThe 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.
Enhancement of Healthcare System Efficiency1 yearhe 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.
Population Health Impact Score1 yearA 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.
Long-Term Public Health Benefit Index1 yearA 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.

Countries

China

Contacts

Primary ContactFei Liu, MD
liufei_2359@163.com+86 13810512704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026