Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorBioMérieux

About this trial

This research study will use a hybrid effectiveness-implementation type 1 design to assess effectiveness of the Spotfire R/ST assay in the urgent care setting. A hybrid effectiveness-implementation type 1 study primarily focuses on the effectiveness of an intervention (e.g., use of Spotfire R/ST) but also simultaneously allows for the collection of data on the barriers and facilitators of implementing the Spotfire R/ST test in the real-world urgent care setting.

Eligibility criteria

Qualifiers

Patients older than 1 year

Patients presenting with signs and symptoms of acute respiratory illness including but not limited to bronchitis, bronchiolitis, rhinitis, pharyngitis, tonsillitis, and laryngitis

First visit for respiratory indication within the study period

Disqualifiers

Patients younger than 1 year

Patients for which there is a clinical suspicion of pneumonia (i.e., severe illness on presentation requiring hospitalization or not eligible for urgent care)

Patients experiencing symptoms for > 10 days

Patients with significant respiratory comorbidities, including COPD, emphysema, pulmonary fibrosis, diseases causing chronic respiratory tract inflammation, and other conditions

Trial design

Treatments tested in this trial

  • SPOTFIRE R/ST Diagnostic Test

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators