Kawasaki MATCH Trial

Official title

Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD

Overview

Evaluating the impact of a machine-learning clinical decision support tool on provider practice when evaluating febrile patients with Kawasaki Disease (KD) and non-KD illnesses.

Detailed description

Following laboratory evaluation, providers will be randomized to treat patients according to usual practice/standard of care vs. receiving clinical decision support from the Kawasaki MATCH tool - a previously validated machine-learning clinical decision support tool to identify Kawasaki Disease. The study aim is to evaluate the accuracy of Kawasaki MATCH prospectively when used at the point of care, as well as how this tool impacts clinical decisions including additional evaluation and hospital admission.

Interventions

• Other Kawasaki MATCH
  Providers access the Kawasaki MATCH decision support tool. Patient information is entered into the tool and a risk score is indicated to the provider. Kawasaki MATCH is a previously validated machine-learning decision support tool for the diagnosis of Kawasaki Disease. This tool utilizes patient age, 18 laboratory features, and 5 clinical features to formulate a risk score.

Primary outcome measures

• Time to Kawasaki Disease treatment (KD patients only) [Time frame: 90 days]

Secondary outcome measures (8)

• Kawasaki MATCH score [Time frame: Day 1 (day of enrollment)]
• Hospital Admission Rate [Time frame: Day 1 (day of enrollment)]
• Kawasaki Disease consultation rate [Time frame: Day 1 (day of enrollment)]
• ED return visit [Time frame: 7 days]
• Additional interventions [Time frame: Day 1 (day of enrollment)]
• Provider assessment of KD likelihood - baseline [Time frame: Day 1 (day of enrollment)]
• Provider assessment of KD likelihood - after algorithm [Time frame: Day 1 (day of enrollment)]
• Algorithm helpfulness [Time frame: Day 1 (day of enrollment)]

Eligibility criteria

Inclusion criteria

• Measured or subjective fever for >= 3 calendar days
• One measured fever >= 38.0 C (home or in ED)
• One or more clinical feature of Kawasaki Disease including:
• Rash
• Conjunctival injection
• Oropharyngeal changes
• Extremity changes (erythema, edema, desquamation)
• Cervical adenopathy (>=1.5cm)
• Infants < 6 months of age with >= 7 days of fever eligible even if none of the above clinical features
• Requires IV/phlebotomy for clinical evaluation

Exclusion criteria

• Congenital or Acquired Immune function
• Genetic disorders
• Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Rady Children's Hospital, San Diego — San Diego

Publications

• Lam JY, Shimizu C, Gardiner MA, Giorgio T, Wright V, Baker A, Anderson MS, Heizer H, Mohandas S, Kazarians A, Kaneta K, Jone PN, Dominguez SR, Szmuszkovicz JR, Newburger JW, Tremoulet AH, Burns JC. External Validation of a Machine Learning Model to Diagnose Kawasaki Disease. J Pediatr. 2025 Jul;282:114543. doi: 10.1016/j.jpeds.2025.114543. Epub 2025 Mar 21. PMID 40122277
• Lam JY, Shimizu C, Tremoulet AH, Bainto E, Roberts SC, Sivilay N, Gardiner MA, Kanegaye JT, Hogan AH, Salazar JC, Mohandas S, Szmuszkovicz JR, Mahanta S, Dionne A, Newburger JW, Ansusinha E, DeBiasi RL, Hao S, Ling XB, Cohen HJ, Nemati S, Burns JC; Pediatric Emergency Medicine Kawasaki Disease Research Group; CHARMS Study Group. A machine-learning algorithm for diagnosis of multisystem inflammator PMID 36150781

Identifiers

NCT: NCT07291245 · 140220 · 68060

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗