Kawasaki MATCH Trial

Официальное название

Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT07291245 · 140220 · 68060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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