Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial

NCT06699433 | Recruiting

• 1 other identifier: Virtual pediatric patients
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Doctor adherence to best clinical practice guidelines

  Doctor adherence to best clinical practice guidelines, i.e., the extent to which doctors consistently make judgments and treatments based on best clinical practice guidelines and progression of the disease. Ordered categorical variable, consisting of three grades: full adherence, partial adherence, and nonadherence. It will be measured using clinical vignette method.

  Through study completion, an average of 6 months

Secondary Outcomes (8)

• Dichotomous variable of doctor adherence to best clinical practice guidelines

  Through study completion, an average of 6 months

• The degree of accuracy of a doctor's diagnosis according to best clinical practice guidelines

  Through study completion, an average of 6 months

• Doctor score of examination that is directly related to handling the disease

  Through study completion, an average of 6 months

• Doctor score of examination that is related to expansion skills of handling the disease

  Through study completion, an average of 6 months

• The level at which the doctor focuses on meeting the actual needs of the patient and gives due consideration to the patient's feelings

  Through study completion, an average of 6 months

Study Arms (3)

Virtual standardized patients (VSPs) training

EXPERIMENTAL

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

Behavioral: Virtual standardized patients (VSPs)

Case teaching manuals

EXPERIMENTAL

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

Behavioral: Case teaching manuals

Case teaching videos

EXPERIMENTAL

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

Behavioral: Case teaching videos

Interventions

Virtual standardized patients (VSPs) 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

Virtual standardized patients (VSPs) training

Case teaching manuals BEHAVIORAL

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

Case teaching manuals

Case teaching videos BEHAVIORAL

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

Case teaching videos

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Primary and secondary hospitals
• Community health centers (stations) and clinics, as well as township health centers and village health clinics
• 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)
• 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
• None

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (3)

Yuntan Street Community Health Center

Guiyang, Guizhou, 550081, China

RECRUITING

Jinxi County People's Hospital

Fuzhou, Jiangxi, 344899, China

RECRUITING

Honghe County People's Hospital

Yisa, Yunnan, 654499, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, Pneumococcal; Hand, Foot and Mouth Disease; Appendicitis; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Intraabdominal Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Respiration Disorders

Study Officials

• Yao Zhao, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo

CONTACT

+86-19566890018; huanyuanluo33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication
• Access Criteria: All collected IPDs will be provided in a timely manner to anyone who has a valid reason for requesting data from the corresponding author.

Locations

CN (3)