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

Not Applicable

Completed

• Conditions: Respiratory Pathogens; Lower Respiratory Tract Illness; Upper Respiratory Tract Illness; Acute Respiratory Infection
• Interventions: Diagnostic Test: Results available to provider

• Registration Number: NCT03756753
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-01-03
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 913

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group- results known	Results available to provider	Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States