Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial

Utilizing Artificial Intelligence-driven Virtual Standardized Pediatric Patients to Enhance the Capabilities of Primary Healthcare Doctors in China for Managing Common Pediatric Diseases: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumococcal Pneumonia; Acute Appendicitis; Respiratory Failure (Pediatric Patients); Hand-foot-and-mouth Disease; Rotavirus Enteritis With Hypovolemic Shock
• Intervention / Treatment: Behavioral: Virtual standardized patients (VSPs); Behavioral: Case teaching manuals; Behavioral: Case teaching videos

• Study Type: Interventional
• Enrollment (Estimated): 459
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luo; Phone Number: +86-19566890018; Email: huanyuanluo33@gmail.com

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550081
      • Recruiting
      • Yuntan Street Community Health Center
  • Jiangxi
    • Fuzhou, Jiangxi, China, 344899
      • Recruiting
      • Jinxi County People's Hospital
  • Yunnan
    • Honghe, Yunnan, China, 654499
      • Recruiting
      • Honghe County People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

1. Inclusion and Exclusion Criteria for Research Institutions

   Inclusion Criteria:

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

   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)
2. Inclusion and exclusion criteria for research subjects

Inclusion Criteria:

• 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:

-None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
Experimental: Case teaching manuals; Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases	Behavioral: Case teaching manuals; Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases
Experimental: Case teaching videos; Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases	Behavioral: Case teaching videos; Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dichotomous variable of doctor adherence to best clinical practice guidelines	Dichotomous variable of doctor adherence to best clinical practice guidelines. Dichotomous variable, consisting of two categories: full adherence, partial adherence or no adherence. It will be measured using clinical vignette method.	Through study completion, an average of 6 months
The degree of accuracy of a doctor's diagnosis according to best clinical practice guidelines	The degree of accuracy of a doctor's diagnosis according to best clinical practice guidelines. Ordered categorical variable, consisting of three categories: fully correct, partially correct, incorrect. It will be measured using clinical vignette method.	Through study completion, an average of 6 months
Doctor score of examination that is directly related to handling the disease	Doctor score of examination that is directly related to handling the disease. It is a continuous variable. It will be measured using examination paper called Disease Handling Capacity Scale. The lowest score is 0, the highest score is 5, and higher scores mean a better outcome.	Through study completion, an average of 6 months
Doctor score of examination that is related to expansion skills of handling the disease	Doctor score of examination that is related to expansion skills of handling the disease. It is a continuous variable. It will be measured using examination paper called Expanded Disease Handling Capacity Scale. The lowest score is 0, the highest score is 5, and higher scores mean a better outcome.	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	The level at which the doctor focuses on meeting the actual needs of the patient and gives due consideration to the patient's feelings. It is a continuous variable. It will be measured using team-developed patient-centered situational question test paper method.	Through study completion, an average of 6 months
Adoption of training by doctors	Implementation outcome: Adoption of training by doctors. Dichotomous variable, consisting of two categories: adopted, not adopted. It will be measured using team-developed questionnaire (self-reported by doctors).	Through study completion, an average of 6 months
Costs to researchers of developing and implementing three types of training	Implementation outcome: Costs to researchers of developing and implementing three types of training. It is a continuous variable. It will be measured using project final account of expenditure.	Through study completion, an average of 6 months
Doctor score of acceptability of three types of training	Implementation outcome: Doctor score of acceptability of three types of training. It is a continuous variable. It will be measured using generic Theoretical Framework of Acceptability (TFA)-based questionnaire self-reported by doctors.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Southern Medical University, China
• Investigators: Principal Investigator: Yao Zhao, Doctor, National Clinical Research Center for Child Health and Disorders, Chongqing, China

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Intestinal Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiration Disorders; Enterovirus Infections; Picornaviridae Infections; Gastroenteritis; Pneumonia; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Cecal Diseases; Pneumococcal Infections; Pneumonia, Bacterial; Intraabdominal Infections; Coxsackievirus Infections; Respiratory Insufficiency; Shock; Pneumonia, Pneumococcal; Hypovolemia; Enteritis; Appendicitis; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: Virtual pediatric patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication, are to be shared.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No