Clinical Intelligent Management System Pragmatic RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-based clinical intelligent management system.
- Who it may be relevant to
- Registry conditions: Primary Care Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Multimodal Model-Based Clinical Intelligent Management System: A Pragmatic Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Comprehensive Assessment of clinical performance [Time frame: From enrollment to the end of treatment at 3 months of all recruited cases]
Secondary outcome measures (1)
- AI-System's appraisal [Time frame: At the end of 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Shanghai Health and Medical Center — Wuxi
Identifiers
NCT: NCT06893068 · 2024-22