Clinical Intelligent Management System Pragmatic RCT
ConditionPrimary Care Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTsinghua University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
AI-based clinical intelligent management system
DeviceThe 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.
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: AI-assist groupExperimental treatment 1 intervention
Group B: Traditional groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Comprehensive Assessment of clinical performance
Primary Care Quaility Assessment Scales (range: 0 to 100 for each case; the higher scores means the better performance)
Time frame
From enrollment to the end of treatment at 3 months of all recruited casesSecondary outcomes
1
AI-System's appraisal
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.)
Time frame
At the end of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov