The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics

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.

• Results available to provider (Diagnostic test): Results of point of care testing are given to provider

Primary outcomes

• Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit [day 0]: Proportion of children who are prescribed an antibiotic at the ED visit.

Secondary outcomes

• Proportion of children treated with influenza antiviral at the ED visit [day 0]: Proportion of patients treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.
• Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit [day 0]: Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.
• ED length of stay (hours) [day 0]: Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.
• Days of Hospitalization [day 0-10]: Proportion of patients hospitalized within 10 days of enrollment in the study
• Number of repeat ED visits [day 0-10]: Number of repeat ED visits within 10 days of enrollment in the study
• Number of tests ordered [day 0]: Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.
• Relative clinical charges [day 0]: Relative clinical charges for ED visit in which a subject is enrolled in the study.

Sex: All, ages: 1 Month to 18 Years

Inclusion Criteria:

1. Age 1 month to < 18 years
2. 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
3. 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
4. Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)

Exclusion Criteria:

1. Respiratory symptom duration > 14 days
2. Previous enrollment in study within past 14 days
3. Nurse-only visit
4. Triage levels 1 and 2 based on Emergency Severity Index

• Results publication: Rao S, Lamb MM, Moss A, Mistry RD, Grice K, Ahmed W, Santos-Cantu D, Kitchen E, Patel C, Ferrari I, Dominguez SR. Effect of Rapid Respiratory Virus Testing on Antibiotic Prescribing Among Children Presenting to the Emergency Department With Acute Respiratory Illness: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2111836. doi: 10.1001/jamanetworkopen.2021.11836. PMID 34086034