The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 913
- 试验地点
- 2
- 主要终点
- Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit
研究概览
简要总结
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention group - results available to medical providers, or the control group- results not available to medical providers.
详细描述
The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in children presenting to an Emergency Department setting with acute respiratory symptoms. The patient cohort will be children 1 month to 18 years of age presenting to the Children's Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population who are evaluated in an urgent care setting. All eligible participants will undergo a nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care). The investigators will compare the clinical outcomes between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Patients will be enrolled in the study, and will not initially know their study arm. After enrollment, the professional research assistant (PRA) will find out the study arm. Providers will be notified of the results for the intervention group. Providers are able to let patients know of their results.
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 month to < 18 years
- •For children aged 1 month to 12 months of age: Presentation to the study sites with temperature > 37.8°C or cough, sore throat, runny nose or nasal congestion
- •For children aged > 1 year to 18 years of age: Presentation to the study sites with influenza like illness, defined as temperature of >37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion
- •Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)
排除标准
- •Respiratory symptom duration > 14 days
- •Previous enrollment in study within past 14 days
- •Nurse-only visit
- •Triage levels 1 and 2 based on Emergency Severity Index
结局指标
主要结局
Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit
时间窗: day 0
Proportion of children who are prescribed an antibiotic at the ED visit.
次要结局
- ED length of stay (hours)(day 0)
- Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit(day 0)
- Number of tests ordered(day 0)
- Relative clinical charges(day 0)
- Proportion of children treated with influenza antiviral at the ED visit(day 0)
- Days of Hospitalization(day 0-10)
- Number of repeat ED visits(day 0-10)