Clinical Intelligent Management System Pragmatic RCT

Not Applicable

Recruiting

• Conditions: Primary Care Diseases

• Registration Number: NCT06893068
• Lead Sponsor: Tsinghua University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-25
• Study Start: 2025-04-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comprehensive Assessment of clinical performance	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)

Secondary Outcome Measures

Name	Time	Method
AI-System's appraisal	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.)

Trial Locations

Locations (1)

Shanghai Health and Medical Center; 🇨🇳 Wuxi, Jiang Su, China