Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial

NCT ID: NCT06699433

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-01-31

Brief Summary

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Background: China's healthcare system for children faces significant challenges, particularly due to the limited pediatric service capacity of primary healthcare institutions. A shortage of effective and accessible training tools for primary care doctors further hinders progress in addressing this gap. Technological advancements, especially in artificial intelligence, offer a potential solution to improve pediatric care. Artificial intelligence-driven virtual standardized patients (VSPs), leveraging internet and virtual simulation technologies, simulate clinical cases with specific disease characteristics, providing an innovative, efficient, and flexible training method. VSPs are increasingly utilized in medical education, clinical reasoning, and licensure exams. This study focuses on using VSPs to improve the management of common pediatric conditions, which are major health concerns for children and impose significant psychological and financial burdens on families.

Methods: This study will involve a three-arm randomized controlled trial to evaluate the effectiveness of a virtual pediatric standardized patient platform in enhancing primary care doctors' management of common pediatric diseases. At least 459 participants, including general practitioners, internal medicine practitioners, surgeons, and pediatricians from more than 10 provinces across China, will be randomly assigned to one of three groups: the virtual patient platform group, the case teaching manual group, or the case teaching video group. Five virtual patient cases covering pneumococcal pneumonia, rotavirus enteritis with hypovolemic shock, hand-foot-and-mouth disease, acute appendicitis, and respiratory failure will be developed, along with corresponding case teaching materials. After a two-week learning period, participants' disease management abilities will be assessed using clinical vignettes. The primary outcome is adherence to best clinical practice guidelines, categorized into full adherence, partial adherence, and nonadherence.

Discussion: This study aims to leverage artificial intelligence for capacity enhancement, targeting the shortcomings of primary care pediatrics and using VSP to help enhance primary care pediatrics capacity. It is a randomized controlled trial involving over 300 primary healthcare institutions across more than 10 provinces in China, ensuring broad and representative participation from both developed and underdeveloped regions.

Detailed Description

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Conditions

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Pneumococcal Pneumonia Rotavirus Enteritis With Hypovolemic Shock Hand-foot-and-mouth Disease Acute Appendicitis Respiratory Failure (Pediatric Patients)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual standardized patients (VSPs) training

Virtual standardized patients (VSPs), utilizing internet and virtual simulation technology, emulate patients with specific disease characteristics and clinical manifestations. With advantages in safety, flexibility, convenience, and efficiency, VSPs are used in medical education, clinical reasoning training, and licensure examinations. Doctors will interact with VSPs to conduct clinical simulations and training, including consultations, physical examinations, auxiliary examinations, and treatment decision-making, to enhance their capabilities for managing common pediatric diseases

Group Type EXPERIMENTAL

Virtual standardized patients (VSPs)

Intervention Type BEHAVIORAL

Virtual standardized patients (VSPs), utilizing internet and virtual simulation technology, emulate patients with specific disease characteristics and clinical manifestations. With advantages in safety, flexibility, convenience, and efficiency, VSPs are used in medical education, clinical reasoning training, and licensure examinations. Doctors will interact with VSPs to conduct clinical simulations and training, including consultations, physical examinations, auxiliary examinations, and treatment decision-making, to enhance their capabilities for managing common pediatric diseases

Case teaching manuals

Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases

Group Type EXPERIMENTAL

Case teaching manuals

Intervention Type BEHAVIORAL

Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases

Case teaching videos

Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases

Group Type EXPERIMENTAL

Case teaching videos

Intervention Type BEHAVIORAL

Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases

Interventions

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Virtual standardized patients (VSPs)

Virtual standardized patients (VSPs), utilizing internet and virtual simulation technology, emulate patients with specific disease characteristics and clinical manifestations. With advantages in safety, flexibility, convenience, and efficiency, VSPs are used in medical education, clinical reasoning training, and licensure examinations. Doctors will interact with VSPs to conduct clinical simulations and training, including consultations, physical examinations, auxiliary examinations, and treatment decision-making, to enhance their capabilities for managing common pediatric diseases

Intervention Type BEHAVIORAL

Case teaching manuals

Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases

Intervention Type BEHAVIORAL

Case teaching videos

Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary and secondary hospitals
* Community health centers (stations) and clinics, as well as township health centers and village health clinics


* Practicing (assistant) doctors and rural doctors working in medical institutions that meet the above conditions
* With a scope of practice only including general practice, internal medicine, surgery, and pediatrics

Exclusion Criteria

* Specialized medical institutions (such as specialized hospitals and dental clinics)
* Public health prevention and treatment institutions (such as tuberculosis prevention centers)
* Ethnic medicine institutions (such as Mongolian and Tibetan hospitals)
* Hospitals above the secondary level
* Hospitals that have not yet been graded (due to their short establishment time and potentially unstable operations)


-None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southern Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Dr. Huanyuan Luo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yao Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Clinical Research Center for Child Health and Disorders, Chongqing, China

Locations

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Yuntan Street Community Health Center

Guiyang, Guizhou, China

Site Status RECRUITING

Jinxi County People's Hospital

Fuzhou, Jiangxi, China

Site Status RECRUITING

Honghe County People's Hospital

Yisa, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo

Role: CONTACT

Phone: +86-19566890018

Email: [email protected]

Other Identifiers

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Virtual pediatric patients

Identifier Type: -

Identifier Source: org_study_id