The FilmArray GI Panel IMPACT Study

Principal Investigator: Andrew  Pavia
Keywords: Gastroenteritis , BioFire , IMPACT Department: Pediatric Infectious Diseases
IRB Number: 00079854 Co Investigator:  
Specialty: Pediatric Gastroenterology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Zeline Salmingo
zeline.salmingo@hsc.utah.edu
801-213-4360

Brief Summary

This study is designed to study the health outcomes of pediatric subjects presenting to emergency departments with GI illness at hospitals before and after introduction of the FilmArray GI Panel (i.e., the intervention). It is hypothesized that the rapid, sensitive, specific, and comprehensive results provided by the FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness and implement appropriate therapy (as well as provide subjects with appropriate expectations about their course of illness) compared to the pre-intervention period. The primary outcomes to be measured are the number of additional healthcare encounters that subjects experience related to the initial GI episode. Additional outcome measurements include (but are not limited to) total healthcare costs, antibiotic prescription rates and appropriateness of therapy, lost time from school/work/daycare, clinician attitudes towards laboratory test capabilities, and subject satisfaction with their healthcare encounter.

The FilmArray GI Panel has been approved by the United States Food and Drug Administration (FDA) for diagnostic use.

Inclusion Criteria

  • Children (<18 years) presenting to the emergency department (ED) or onsite urgent care center with symptoms of suspected gastroenteritis (e.g., diarrhea, vomiting, nausea, etc.)
  • Duration of symptoms <14 days
  • Able to provide a stool specimen at the time of enrollment or within the next two calendar days
  • Parent or guardian able to provide permission and subject able to provide assent, if appropriate

Exclusion Criteria

  • Undefined onset of illness or symptoms for ≥14 days
  • Unable to complete questionnaire or give informed consent because of language barrier
  • Those unable to provide a stool specimen at the time of enrollment or within two calendar days
    • Subjects who are unable to submit a specimen within two calendar days will be excluded after enrollment and will not be counted towards the enrollment goal of 1,500
  • Previous enrollment in this study
  • Subject is a member of a household from which another subject has been enrolled within the previous 28 days