The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intervention group- results known 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
Results of point of care testing are given to provider
|
No Intervention: Control group- results not known Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- Number of repeat ED visits [day 0-10]
Number of repeat ED visits within 10 days of enrollment 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 1 month to < 18 years
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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
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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
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Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)
Exclusion Criteria:
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Respiratory symptom duration > 14 days
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Previous enrollment in study within past 14 days
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Nurse-only visit
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Triage levels 1 and 2 based on Emergency Severity Index
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- Biofire
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-1492