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Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics

Primary Purpose

Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Infection focused on measuring rapid viral diagnosis, respiratory infection, pediatric emergency department, febrile respiratory infection

Eligibility Criteria

3 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Admitted to the BCCH ED with fever (≥38.5 0C) and one or more of the following: cough, runny nose, sore throat, or congested nose. Exclusion Criteria: Excluded from the study will be patients who are: immuno-compromised, have chronic severe respiratory conditions (cystic fibrosis, bronchopulmonary dysplasia), chronic heart conditions or who is in severe distress requiring immediate care or resuscitation, or have had prior assessment in our ED department for the current illness. Only one child per family can be enrolled.

Sites / Locations

  • Children's and Women's Health Centre of BC

Outcomes

Primary Outcome Measures

Length of Emergency Department visit (from initial physician contact to discharge from Emergency Department)

Secondary Outcome Measures

Rate of antibiotic prescription in Emergency Department.
Rate of ancillary tests performed in Emergency Department.

Full Information

First Posted
January 16, 2006
Last Updated
February 17, 2009
Sponsor
University of British Columbia
Collaborators
Michael Smith Foundation for Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT00278759
Brief Title
Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics
Official Title
Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics. A Randomized Controlled Trial of Decision Making Based Upon Early (at Triage) Rapid Diagnosis of Respiratory Viral Infections (VIRAP) in Children 3-36 Months of Age Presenting to the Emergency Department (ED) With a Flu-Like Illness.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia
Collaborators
Michael Smith Foundation for Health Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute respiratory tract infections are among the most common problems of childhood, particularly among infants and children younger than 3 years, and account for most antibiotic prescriptions to children. Most of these infections are self-limited and do not require medical intervention; however, the symptoms overlap significantly with those of severe viral or bacterial infections. At the hospital Emergency Department (ED), medical assessment, prescription of antibiotics (unnecessarily if the infection is viral), and a series of investigations (e.g., blood work, X-rays) often take place before a decision on patient management and possible hospital admission can be made. Such procedures lead to intense use of human health resources (nursing, laboratory and radiology staff) and hospital facilities. The literature suggests that a prompt single viral diagnosis improves decision-making. To our knowledge, no-one has performed a controlled trial to examine the impact of a rapid, multi-viral detection test like VIRAP, or the impact of the timing of such a test, on management of children with flu-like illnesses in the ED. Our objective is to determine if use of our new viral detection program, VIRAP, for rapid testing for viral respiratory infections right after triage will improve patient management and resource use in the ED. We will test the hypothesis that availability of VIRAP at triage to support rapid diagnosis of viral infection in children at BCCH will (i) reduce the waiting time in the ED; (ii) improve decision making regarding diagnostic investigations and specimen collection; and (iii) decrease antibiotic prescriptions. Study completed and manuscript accepted for publication in the Journal of Pediatrics.
Detailed Description
Description of Project: Background: Acute viral respiratory tract infections are among the most common infectious problems of childhood during the first five years of life, particularly among infants younger than 2 years of age. Although the majority of these infections does not require medical attention and are self-limited in nature, worried parents commonly bring their children to the emergency department (ED) for evaluation (average 2500 children/winter). EDs are choke points in the health care system, especially at the peaks of the annual influenza season and respiratory syncytial virus (RSV) season. Without a prompt specific viral diagnosis in a child presenting to the ED with a febrile respiratory illness, after being seen by a physician, a child may have to undergo a constellation of precautionary diagnostic tests (septic work up, CXR) and be prescribed antibiotics unnecessarily. These interventions lead to prolonged ED stays (average 180min +/-120 min), intense use of human health resources (nursing, laboratory and radiology staff) resulting in significant cost both direct and indirect to the health care system, as well as time lost to the children and their families and contribute to antimicrobial resistance. The precise etiology of these viral infection episodes can be determined through the use of rapid screening program such as VIRAP (nasopharyngeal washing for rapid direct viral antigen detection via immunofluorescence). At the moment VIRAP is a physician ordered test, done only after the child has been seen by the physician, usually after the child has already been waiting for a significant length of time, then has to wait further for the results of the test. Hypothesis: Rapid diagnosis of viral infection through VIRAP initiated by a nurse at triage wit results available for ED physician time of assessment may influence decision making with respect to additional investigations therefore reduce the amount of waiting time in the ED, as well as decrease antibiotic prescriptions. This would ultimately result in improved effectiveness of service provision for children with febrile respiratory illnesses and in turn shorten waiting time for all children in the ED. Health care cost reduction by minimising unnecessary diagnostic tests being performed and antibiotic prescription are also expected. Study design: We propose to conduct a single centre, open label, randomized controlled trial comparing outcomes of patients undergoing VIRAP at triage vs routine ED admission protocol. During the months of December 2005 to April, and again Dec2006 to April 2007, eligible patients based on our inclusion and exclusion will be enrolled at triage and randomized in a 1:1 ratio to either undergo NPW for VIRAP and have the result available to the treating physician at time of assessment or routine admitting protocol to the ED and await physician assessment without prior investigation. Criteria: Patients age 3-36 months admitted to the BCCH ED with fever(≥38.5 0C measured in ED or documented by the accompanying parent) and at least one of: cough, runny nose, nasal congestion and sore throat will be eligible for enrolment. Excluded from the study will be patients who are immuno-compromised, who have underlying chronic severe respiratory conditions (cystic fibrosis, bronchopulmonary dysplasia) or chronic heart conditions (uncorrected cyanotic heart lesions, prosthetic valves), who have had prior assessment in our ED department for the current illness. Only one child per family can be enrolled. End points: The duration of stay in ED (from assessment to discharge, including time waiting for investigations and review of results by the physician) is the primary endpoint. Secondary endpoints include whether any investigations following the assessment (blood test, radiographs or urine tests) were ordered and whether study patients were prescribed antibiotics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection
Keywords
rapid viral diagnosis, respiratory infection, pediatric emergency department, febrile respiratory infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
Length of Emergency Department visit (from initial physician contact to discharge from Emergency Department)
Secondary Outcome Measure Information:
Title
Rate of antibiotic prescription in Emergency Department.
Title
Rate of ancillary tests performed in Emergency Department.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Admitted to the BCCH ED with fever (≥38.5 0C) and one or more of the following: cough, runny nose, sore throat, or congested nose. Exclusion Criteria: Excluded from the study will be patients who are: immuno-compromised, have chronic severe respiratory conditions (cystic fibrosis, bronchopulmonary dysplasia), chronic heart conditions or who is in severe distress requiring immediate care or resuscitation, or have had prior assessment in our ED department for the current illness. Only one child per family can be enrolled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Thomas, MD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's and Women's Health Centre of BC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

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Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics

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