RecruitingNot ApplicableNCT06893068

Clinical Intelligent Management System Pragmatic RCT

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


Sponsor

Tsinghua University

Enrollment

204 participants

Start Date

Apr 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

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

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Interventions

DEVICEAI-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.


Locations(1)

Shanghai Health and Medical Center

Wuxi, Jiangsu, China

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NCT06893068


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