An interventional study of Virtual standardized patients (VSPs) and Case teaching manuals in Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock and Hand-foot-and-mouth Disease, sponsored by Southern Medical University, China. Recruiting at 3 sites in China. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Southern Medical University, China · Not applicable, Interventional, and Health services research
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.
44 studies on the registry are indexed under Pneumonia, Pneumococcal; 2 are open to participants now.
This study's planned enrollment of 459 is above the median of 388 across 37 interventional studies indexed under Pneumonia, Pneumococcal.
Browse Pneumonia, Pneumococcal studies →Southern Medical University, China is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
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Inclusion and Exclusion Criteria for Research Institutions
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
-None
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)
Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases
Behavioral: Case teaching manuals
Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases
Behavioral: Case teaching videos
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
Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases
Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases
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.
Time frame: Through study completion, an average of 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
Plan to share: Yes — All collected IPD, all IPD that underlie results in a publication, are to be shared.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2024, 0 months later.
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Southern Medical University, China