Clinical Intelligent Management System Pragmatic RCT

Tsinghua University

Status: Enrolling

Conditions: Primary Care Diseases

Treatments: Device: AI-based clinical intelligent management system

Study type: Interventional

Funder types: Other

Identifiers

NCT06893068

2024-22

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

AI-assist group

Experimental group

Description:

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.

Treatment:

Device: AI-based clinical intelligent management system

Traditional group

No Intervention group

Description:

Physicians in the control group will conduct routine diagnoses and treatments, while patients will receive standard health education and follow-up care.