Pneumococcal PneumoniaNCT06699433
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
A study testing Virtual standardized patients (VSPs), Case teaching manuals and Case teaching videos in people with Pneumococcal Pneumonia and Rotavirus Enteritis With Hypovolemic Shock, run by Southern Medical University, China at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock, Hand-foot-and-mouth Disease
- What is being tested?
- Virtual standardized patients (VSPs), Case teaching manuals and Case teaching videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary and secondary hospitals
- Community health centers (stations) and clinics, as well as township health centers and village health clinics
- 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
Who cannot join
- 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)
- Inclusion and exclusion criteria for research subjects
- -None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Jinxi County People's Hospital
Fuzhou, Jiangxi, 344899
- Recruiting
Yuntan Street Community Health Center
Guiyang, Guizhou, 550081
- Recruiting
Honghe County People's Hospital
Yisa, Yunnan, 654499
About this study
Official title: 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.
- Conditions
- Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock, Hand-foot-and-mouth Disease, Acute Appendicitis, Respiratory Failure (Pediatric Patients)
- Being tested
- Virtual standardized patients (VSPs), Case teaching manuals, Case teaching videos
- Medical subject headings
- Pneumonia, Pneumococcal, Hand, Foot and Mouth Disease, Appendicitis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual standardized patients (VSPs)Behavioural
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
Case teaching manualsBehavioural
Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases
Case teaching videosBehavioural
Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Virtual standardized patients (VSPs) |
| Case teaching manuals | Experimental | Doctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases Receives: Behavioral: Case teaching manuals |
| Case teaching videos | Experimental | Doctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases Receives: Behavioral: Case teaching videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 459 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Huanyuan Luo, Southern Medical University, China
- Investigators
- Yao Zhao, Doctor, Principal investigator, National Clinical Research Center for Child Health and Disorders, Chongqing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699433
- Sponsor's protocol ID
- Virtual pediatric patients
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication, are to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06699433
- Acronym / sponsor ID
- Virtual pediatric patients
- Conditions
- Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock, Hand-foot-and-mouth Disease, Acute Appendicitis, Respiratory Failure (Pediatric Patients)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 459 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual standardized patients (VSPs) training | Experimental | 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 |
| Case teaching manuals | Experimental | Behavioral: Case teaching manualsDoctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases |
| Case teaching videos | Experimental | Behavioral: Case teaching videosDoctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Inclusion and exclusion criteria for research subjects
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Virtual standardized patients (VSPs) training |
| Case teaching manualsDoctors will use case teaching manuals to enhance their capabilities for managing common pediatric diseases | Behavioural | Case teaching manuals |
| Case teaching videosDoctors will use case teaching videos to enhance their capabilities for managing common pediatric diseases | Behavioural | Case teaching videos |
Primary outcome
Doctor adherence to best clinical practice guidelines
Time frame: 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.
8 secondary outcomes
Dichotomous variable of doctor adherence to best clinical practice guidelines
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
Time frame: Through study completion, an average of 6 months
Doctor score of examination that is directly related to handling the disease
Time frame: Through study completion, an average of 6 months
Doctor score of examination that is related to expansion skills of handling the disease
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
Time frame: Through study completion, an average of 6 months
Adoption of training by doctors
Time frame: Through study completion, an average of 6 months
Costs to researchers of developing and implementing three types of training
Time frame: Through study completion, an average of 6 months
Doctor score of acceptability of three types of training
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication, are to be shared.
Related trials for Pneumococcal Pneumonia
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruitingPhase 1
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose
Pneumonia, Bacterial
RecruitingObservational study
Urine Pneumococcal Antigen Project
Pneumonia, Pneumonia - Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Not yet recruitingPhase 1
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age
Pneumonia, Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yao Zhao, Doctor principal investigator
National Clinical Research Center for Child Health and Disorders, Chongqing, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual standardized patients (VSPs), Case teaching manuals and Case teaching videos in people with Pneumococcal Pneumonia and Rotavirus Enteritis With Hypovolemic Shock, run by Southern Medical University, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luo (+86-19566890018, huanyuanluo33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doctor adherence to best clinical practice guidelines (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.