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NCT Number: NCT06893068

Clinical Intelligent Management System Pragmatic RCT

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Health and Medical Center

Wuxi, Jiangsu, 214065, China

Location status: Recruiting

Location contact

Jing Gu

CONTACT

[email protected]

86+(510)82335104

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. AI-System's appraisal

    Time frame: At the end of 3 months

    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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Gu

CONTACT

[email protected]

86+(510)82335104

Sponsors and collaborators

Lead sponsor

Tsinghua University

Other

Registry information

Official study title

Evaluation of a Multimodal Model-Based Clinical Intelligent Management System: A Pragmatic Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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