Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics
Condition: Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Emergencies
Study type: Interventional

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.
    

Intervention name(s): Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.
Intervention type(s): Procedure
Intervention description(s): See Detailed Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: rapid viral diagnosis; respiratory infection; pediatric emergency department; febrile respiratory infection