Acute Respiratory Infection, Lower Respiratory Tract Illness, Respiratory Pathogens, Upper Respiratory Tract Illness
Conditions
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.
Interventions
DIAGNOSTIC_TESTResults available to provider
Results of point of care testing are given to provider
Sponsors
Biofire
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Days of Hospitalization | day 0-10 | Proportion of patients hospitalized within 10 days of enrollment 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. |
| 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. |
| Number of repeat ED visits | day 0-10 | Number of repeat ED visits within 10 days of enrollment in the study |
Countries
United States
Outcome results
None listed