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

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

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.

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.

Respiratory Pathogens, Upper Respiratory Tract Illness, Lower Respiratory Tract Illness, Acute Respiratory Infection

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).

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.

Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results

Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results

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

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.

Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.

Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.

Inclusion Criteria: 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) Exclusion Criteria: 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

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.