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| Name | Class |
|---|---|
| BioFire Diagnostics, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group- results known | Experimental | Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results |
|
| Control group- results not known | No Intervention | Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Results available to provider | Diagnostic Test | Results of point of care testing are given to provider |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit | Proportion of children who are prescribed an antibiotic at the ED visit. | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 0 |
| Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34086034 | Derived | Rao S, Lamb MM, Moss A, Mistry RD, Grice K, Ahmed W, Santos-Cantu D, Kitchen E, Patel C, Ferrari I, Dominguez SR. Effect of Rapid Respiratory Virus Testing on Antibiotic Prescribing Among Children Presenting to the Emergency Department With Acute Respiratory Illness: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2111836. doi: 10.1001/jamanetworkopen.2021.11836. |
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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).
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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.
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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. |
| 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. | day 0 |
| Days of Hospitalization | Proportion of patients hospitalized within 10 days of enrollment in the study | day 0-10 |
| Number of repeat ED visits | Number of repeat ED visits within 10 days of enrollment in the study | 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. | day 0 |
| Relative clinical charges | Relative clinical charges for ED visit in which a subject is enrolled in the study. | day 0 |