Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting

The FilmArray RP EZ may offer improvements over conventional CLIA-waived testing for respiratory infections. Molecular-based testing provides increased sensitivity and specificity relative to current clinical reference methods and multiplexed panels offer a greater breadth of organism identification and diagnostic yield than is available using standard methods available in the CLIA-waived setting. Because of these attributes, the results from this test have the potential to enable clinicians to more accurately diagnose and treat respiratory illness. It is hypothesized that the sensitive, specific, and comprehensive results provided by FilmArray RP EZ will allow clinicians to more rapidly diagnose respiratory illness and implement appropriate therapy, as well as provide subjects with appropriate expectations about their course of illness. This interventional clinical trial that will be initiated during the 2016-2017 respiratory illness season to measure the utility of FilmArray RP EZ when implemented in an outpatient care setting. At least three different outpatient or urgent care clinics within the UCLA Health system will be selected for participation. Subjects will be randomized into two groups within each site. The control group will receive standard of care according to the subject's provider's determination. The intervention group will receive testing with FilmArray RP EZ. Outcome measures will include (but are not limited to) total healthcare costs, antimicrobial prescription rates, timeliness, and appropriateness of therapy, clinician attitudes towards laboratory test capabilities, and subject satisfaction with their healthcare encounter. As specimens will be collected specifically for this research study, written informed consent, assent, and/or parental permission will be obtained from all study participants.