Evaluation of a Multimodal Model-Based Clinical Intelligent Management System: A Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tsinghua University
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Comprehensive Assessment of clinical performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: AI-based clinical intelligent management system (Device)
Traditional group
Physicians in the control group will conduct routine diagnoses and treatments, while patients will receive standard health education and follow-up care.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- AI-System's appraisal(At the end of 3 months)
Investigators
Tien Yin Wong
Professor
Tsinghua University