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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06699433
Enrollment
459
Registered
2024-11-21
Start date
2024-12-31
Completion date
2025-01-31
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALVirtual 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

BEHAVIORALCase teaching manuals

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

BEHAVIORALCase teaching videos

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

Sponsors

Southern Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Doctor adherence to best clinical practice guidelinesThrough study completion, an average of 6 monthsDoctor 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.

Secondary

MeasureTime frameDescription
The degree of accuracy of a doctor's diagnosis according to best clinical practice guidelinesThrough study completion, an average of 6 monthsThe 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.
Doctor score of examination that is directly related to handling the diseaseThrough study completion, an average of 6 monthsDoctor 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.
Doctor score of examination that is related to expansion skills of handling the diseaseThrough study completion, an average of 6 monthsDoctor 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.
Dichotomous variable of doctor adherence to best clinical practice guidelinesThrough study completion, an average of 6 monthsDichotomous 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.
Adoption of training by doctorsThrough study completion, an average of 6 monthsImplementation 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).
Costs to researchers of developing and implementing three types of trainingThrough study completion, an average of 6 monthsImplementation 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.
Doctor score of acceptability of three types of trainingThrough study completion, an average of 6 monthsImplementation 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.
The level at which the doctor focuses on meeting the actual needs of the patient and gives due consideration to the patient's feelingsThrough study completion, an average of 6 monthsThe 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.

Countries

China

Contacts

Primary ContactLuo
huanyuanluo33@gmail.com+86-19566890018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026