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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-assist group | Experimental | 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. |
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| Traditional group | No Intervention | Physicians in the control group will conduct routine diagnoses and treatments, while patients will receive standard health education and follow-up care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-based clinical intelligent management system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Assessment of clinical performance | Primary Care Quaility Assessment Scales (range: 0 to 100 for each case; the higher scores means the better performance) | From enrollment to the end of treatment at 3 months of all recruited cases |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | At the end of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Gu | Contact | 86+(510)82335104 | g950324@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tien Yin Wong | Tsinghua University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Health and Medical Center | Recruiting | Wuxi | Jiangsu | 214065 | China |
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