Clinical Intelligent Management System - Multilingual Exploration

May 13, 2025 updated by: Tien Yin Wong, Tsinghua University

Multilingual Exploration of the Clinical Intelligent Management System Based on a Multimodal Foundation Model

This study aims to explore the diagnostic and therapeutic performance of a multimodal foundation model-based clinical intelligent management system in simulated outpatient scenarios. Specifically, it will compare the system's AI agent with general practitioners from different linguistic and cultural backgrounds worldwide, as well as various dialect and minority language regions in China.

The study will be conducted across multiple centers in diverse regions to comprehensively evaluate the system's adaptability. Using a prospective, single-blind design, each center will recruit primary care physicians.

Standardized simulated patients across all centers will be trained based on the same set of standardized cases and then will consult with four real physicians and the AI agent, ensuring consistency.

By comparing diagnostic and treatment quality, patient satisfaction, and clinical outcomes, this study aims to explore the system's effectiveness in enhancing primary care and patient management across different regions and linguistic environments.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 102218
        • Recruiting
        • Tiantongyuan North Community Healthcare Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria for primary care physicians:

  • Fluent in the local languages spoken at each center.
  • With the general practice medical qualifications.
  • Agree to participate in the study and sign the informed consent form.

Inclusion criteria for simulated patient volunteers:

  • Age ≥ 18 years.
  • Fluent in the local languages spoken at each center.
  • Able to use electronic devices with intelligent systems.
  • Able to accurately express symptoms and participate throughout the process.
  • Agree to participate in the study and sign the informed consent form.

Exclision criteria: N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AI Agent Doctor group
Standardized simulated patients consult with AI Agent Doctor, providing AI-generated diagnoses and treatments for health care.
The clinical intelligent AI system is equipped with an AI agent doctor, enabling patients to conduct self-consultations and receive care anytime and anywhere without the need for a real doctor.
No Intervention: Primary care physicians groups
Standardized simulated patients consult with physicians, providing routine diagnoses and treatments as their usual standard health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Assessment of physician's clinical abilities
Time Frame: Immediately after the simulated consultation
Clinical Abilities Assessment Scales for Primary Care (range: 0 to 100 for each case; the higher scores means the better performance)
Immediately after the simulated consultation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System's Usability
Time Frame: Immediately after the simulated consultation with AI system
System Usability Evaluation Scale accessed by participating simulated patients, rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). (A higher scale value indicates higher perceived usability of the technology.)
Immediately after the simulated consultation with AI system

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 24694-4-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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