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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Results available to provider


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group- results known<br>Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results | Diagnostic Test: Results available to provider<br>* Results of point of care testing are given to provider<br>|
| No Intervention: Control group- results not known<br>Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit | Proportion of children who are prescribed an antibiotic at the ED visit. | day 0 | 

Secondary Outcome Measures

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