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

University of Colorado, Denver913 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

913

Conditions

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

Interventions

Results available to providerDIAGNOSTIC_TEST

Results of point of care testing are given to provider

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit

Proportion of children who are prescribed an antibiotic at the ED visit.

Time frame: day 0

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: day 0

Days of Hospitalization

Proportion of patients hospitalized within 10 days of enrollment in the study

Time frame: day 0-10

Number of repeat ED visits

Number of repeat ED visits within 10 days of enrollment in the study

Time frame: 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.

Time frame: day 0

Data from ClinicalTrials.gov

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