Kawasaki MATCH Trial

University of California San Diego

Status: Enrolling

Conditions: Kawasaki Disease

Treatments: Other: Kawasaki MATCH

Study type: Interventional

Funder types: Other

Identifiers

NCT07291245

140220

68060 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 days to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Kawasaki MATCH

Experimental group

Description:

Providers encouraged to access and utilize the Kawasaki MATCH decision support tool when evaluating and managing patients in the Emergency Department

Treatment:

Other: Kawasaki MATCH

Routine Care

No Intervention group

Description:

Providers prompted to manage patients as per usual/routine care without additional decision support.