Clinical Intelligent Management System Pragmatic RCT

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

Evaluation of a Multimodal Model-Based Clinical Intelligent Management System: A Pragmatic Randomized Controlled Trial

This study aims to evaluate the effectiveness of a clinical intelligent management system, based on a multimodal foundational model, in improving the quality of primary care at a community health service center.

Using a prospective, randomized controlled, single-blind study design, the trial will include primary care physicians and adult patients seeking care at the Tiantongyuanbei Community Health Service Center and Shanghai Health and Medical Center.

Physicians in the intervention group will utilize the intelligent management system with AR glasses to aid in diagnosis and treatment, while patients will engage with the system's patient interface to access health education, follow-up reminders, and AI-powered home consultation features. In contrast, physicians in the control group will provide routine diagnoses and treatments, with their patients receiving standard health education and follow-up care. The trial was designed with the assistance of a digital twin-based clinical research system (termed X Town).

By comprehensively evaluating diagnostic quality, physicians' clinical abilities, patient-reported outcomes, and system appraisals, this study will assess the effectiveness of the clinical intelligent management system in enhancing the quality of primary care and patient management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

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 Contact

Study Locations

  • China
    • Jiang Su
      • Wuxi, Jiang Su, China, 214065
        • Recruiting
        • Shanghai Health and Medical 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:

  • Age ≥18 years
  • Receiving care at a community health service center
  • Able to understand and comply with the study procedures
  • Agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

  • Patients with severe mental illness
  • Patients unable to independently complete the questionnaire
  • Patients expected to be unable to complete follow-ups within three months

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-assist group
Physicians in the intervention group will employ the intelligent management system with AR glasses to assist in diagnosis and treatment, while patients will interact with the system's patient interface to access health education, follow-up reminders, and AI-powered home consultation features.
Device: AI-based clinical intelligent management system
The clinical intelligent management system, integrated with AR glasses and powered by a multimodal foundational model, is designed to improve the quality of outpatient care at community health service centers.
No Intervention: Traditional group
Physicians in the control group will conduct routine diagnoses and treatments, while patients will receive standard health education and follow-up care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Assessment of clinical performance
Time Frame: From enrollment to the end of treatment at 3 months of all recruited cases
Primary Care Quaility Assessment Scales (range: 0 to 100 for each case; the higher scores means the better performance)
From enrollment to the end of treatment at 3 months of all recruited cases

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AI-System's appraisal
Time Frame: At the end of 3 months
System usability was accessed by participating doctors of an AI-assisted group using the Health Information Technology Usability Evaluation Scale, 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.)
At the end of 3 months

Collaborators and Investigators

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

Sponsor

Tsinghua University

Investigators

  • Principal Investigator: Tien Yin Wong, Tsinghua University

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 13, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 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

  • 2024-22

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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