NCT03756753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
913

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

November 27, 2018

Last Update Submit

November 5, 2021

Conditions

Respiratory PathogensUpper Respiratory Tract IllnessLower Respiratory Tract IllnessAcute Respiratory Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Proportion of children 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

    day 0

  • ED length of stay (hours)

    day 0

  • Days of Hospitalization

    day 0-10

  • Number of repeat ED visits

    day 0-10

  • +2 more secondary outcomes

Study Arms (2)

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

Diagnostic Test: Results available to provider

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

Interventions

Results available to providerDIAGNOSTIC_TEST

Results of point of care testing are given to provider

Intervention group- results known

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 1 month to \< 18 years
  • 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
  • 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
  • Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)

You may not qualify if:

  • Respiratory symptom duration \> 14 days
  • Previous enrollment in study within past 14 days
  • Nurse-only visit
  • Triage levels 1 and 2 based on Emergency Severity Index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

    PMID: 34086034DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 28, 2018

Study Start

January 3, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)