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
BioMérieux
800 participants
Dec 22, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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
Exclusion Criteria6
- 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
- Patients with other significant oropharyngeal or upper respiratory comorbidities or conditions, including but not limited to nasal deformations, peritonsillar abscess
- Had a previous visit for respiratory indication within the study period
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Interventions
At the intervention site, subjects meeting the inclusion and exclusion criteria, and who provide consent to participate in the study, will have a respiratory sample tested on the SPOTFIRE R/ST Panel, with results used by the treating clinician to guide management . At the end of the visit, enrolled patients will take a satisfaction survey, based on the AHRQ-validated CAHPS survey
Locations(2)
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NCT07513519