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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT03756753
Collaborator
Biofire (Other)
913
1
2
23.9
38.2

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
  • Diagnostic Test: Results available to provider
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

Study Type:
Interventional
Actual Enrollment :
913 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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).
Masking:
None (Open Label)
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.
Primary Purpose:
Other
Official Title:
The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
Actual Study Start Date :
Jan 3, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. Days of Hospitalization [day 0-10]

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

  5. Number of repeat ED visits [day 0-10]

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

  6. 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.

  7. Relative clinical charges [day 0]

    Relative clinical charges for ED visit in which a subject is enrolled in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT03756753
Other Study ID Numbers:
  • 18-1492
First Posted:
Nov 28, 2018
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021