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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Upper Respiratory Tract Illness; Acute Respiratory Infection; Lower Respiratory Tract Illness; Respiratory Pathogens

Treatments: Diagnostic Test: Results available to provider

Study type: Interventional

Funder types: Other

Identifiers

NCT03756753

18-1492

Details and patient eligibility

About

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.

Full 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.

Enrollment: 913 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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913 participants in 2 patient groups

Intervention group- results known

Experimental group

Description:

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

Treatment:

Diagnostic Test: Results available to provider

Control group- results not known

No Intervention group

Description:

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