Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial

Not Applicable

Recruiting

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

• Registration Number: NCT06699433
• Lead Sponsor: Southern Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Status Verified: 2024-12
• Study Start: 2024-12
• Primary Completion: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-19
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 459

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Doctor adherence to best clinical practice guidelines	Through study completion, an average of 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Dichotomous variable of doctor adherence to best clinical practice guidelines	Through study completion, an average of 6 months	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.
The degree of accuracy of a doctor's diagnosis according 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. 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 disease	Through study completion, an average of 6 months	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.
Doctor score of examination that is related to expansion skills of 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. 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.
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	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.
Adoption of training by doctors	Through study completion, an average of 6 months	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).
Costs to researchers of developing and implementing three types of training	Through study completion, an average of 6 months	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.
Doctor score of acceptability of three types of training	Through study completion, an average of 6 months	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.

Trial Locations

Locations (3)

Yuntan Street Community Health Center; 🇨🇳 Guiyang, Guizhou, China

Jinxi County People's Hospital; 🇨🇳 Fuzhou, Jiangxi, China

Honghe County People's Hospital; 🇨🇳 Honghe, Yunnan, China