Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to Kawasaki Disease treatment (KD patients only)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •Congenital or Acquired Immune function
- •Genetic disorders
- •Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)
结局指标
主要结局
Time to Kawasaki Disease treatment (KD patients only)
时间窗: 90 days
Time in days from initial ED evaluation to initial IVIG treatment in patients ultimately diagnosed with Kawasaki Disease
次要结局
- Algorithm helpfulness(Day 1 (day of enrollment))
- Kawasaki Disease consultation rate(Day 1 (day of enrollment))
- Provider assessment of KD likelihood - baseline(Day 1 (day of enrollment))
- Provider assessment of KD likelihood - after algorithm(Day 1 (day of enrollment))
- Kawasaki MATCH score(Day 1 (day of enrollment))
- Hospital Admission Rate(Day 1 (day of enrollment))
- ED return visit(7 days)
- Additional interventions(Day 1 (day of enrollment))
研究者
Michael Gardiner
Associate Clinical Professor, Associate Division Chief of Research
University of California, San Diego