External Validation of a Machine Learning Model to Diagnose Kawasaki Disease.
Jonathan Y Lam, Chisato Shimizu, Michael A Gardiner...
https://pubmed.ncbi.nlm.nih.gov/40122277Actively Recruiting
Phase Not Applicable
Age: 30Days - 17Years
All Genders
ID07291245
Kawasaki MATCH: A Clinical Decision Support Tool to Detect Kawasaki Disease
Led by University of California, San Diego · Updated on 2025-12-18
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
G
Gordon and Marilyn Macklin Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of a machine-learning clinical decision support tool called Kawasaki MATCH on how healthcare providers diagnose and manage patients with Kawasaki Disease (KD) and other febrile illnesses. The study aims to assess the accuracy of Kawasaki MATCH when used at the point of care and its influence on clinical decisions such as additional testing and hospital admissions. Participants' healthcare providers will be randomly assigned to one of two groups: one group will use the Kawasaki MATCH decision support tool to help identify KD by entering patient information including age, laboratory results, and clinical features to generate a risk score; the other group will follow standard care without the decision support tool. This setup will allow researchers to compare usual care with care guided by the Kawasaki MATCH tool. During the study, providers will record assessments and decisions about patients presenting with fever and possible KD. Researchers will track outcomes including the time to treatment for KD patients, hospital admission rates, additional interventions, consultations, and return visits to the emergency department. The study will also gather feedback from providers on the usefulness of the decision support tool. Participation will involve follow-up over 90 days to monitor treatment timing and outcomes.
CONDITIONS
Brief Title
Kawasaki MATCH Trial
Who Can Participate
Age: 30Days - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Measured or subjective fever for 3 or more calendar days
- One measured fever of 38.0 C or higher (at home or in the emergency department)
- One or more clinical features of Kawasaki Disease including rash, conjunctival injection, oropharyngeal changes, extremity changes, or cervical adenopathy (1.5 cm or larger)
- Infants younger than 6 months with 7 or more days of fever are eligible even without other clinical features
- Requires intravenous access or blood draw for clinical evaluation
You will not qualify if you...
- Congenital or acquired immune function disorders
- Genetic disorders
- Current treatment with systemic steroids, immunosuppressants, or chemotherapy (inhaled steroids excluded)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day 1 (day of enrollment)
Participants undergo laboratory evaluation and clinical assessment to identify features of Kawasaki Disease and to determine risk using the Kawasaki MATCH decision support tool or routine care.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 90 days
Participants are monitored for clinical outcomes including treatment timing, hospital admission, consultation rates, and emergency department return visits.
Follow-up within 7 days and other assessments up to 90 days
Trial Site Locations
Total: 1 location
1
Rady Children's Hospital, San Diego
San Diego, California, United States, 92071
Actively Recruiting
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Research Team
M
Michael A Gardiner, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
A machine-learning algorithm for diagnosis of multisystem inflammatory syndrome in children and Kawasaki disease in the USA: a retrospective model development and validation study.
Jonathan Y Lam, Chisato Shimizu, Adriana H Tremoulet...
https://pubmed.ncbi.nlm.nih.gov/36150781