Study of the Spotfire Multiplex Respiratory PCR Test for Patients With Acute Respiratory Illness in Urgent Care Settings A Hybrid-Effectiveness Trial Evaluating Patient Outcomes and Antibiotic Use

What this Trial Is About

Researchers are evaluating the effectiveness and implementation of the Spotfire RST multiplex respiratory PCR test in urgent care settings for patients presenting with acute respiratory infections. These infections often lead to high rates of unnecessary antibiotic use, which contributes to antimicrobial resistance and adverse events. The study focuses on how this rapid diagnostic test can influence antibiotic prescribing and patient outcomes while also exploring challenges and facilitators to adopting the test in real-world urgent care clinics. The study compares two groups patients at an intervention site where respiratory samples are tested using the Spotfire RST Panel and results guide clinical decisions, and patients at a control site where standard respiratory antigen tests are used. The Spotfire test detects multiple viral and bacterial targets from nasopharyngeal or throat swabs, providing results in about 15 minutes. Patients at both sites complete a patient satisfaction survey, and providers at the intervention site participate in antimicrobial stewardship and implementation science activities designed before the study began. Participants will have their respiratory samples collected and tested, followed by evaluation of antibiotic use and patient satisfaction. Researchers will monitor antibiotic prescribing rates, antiviral use, patient visit length, and implementation outcomes over approximately 16 weeks from enrollment. The primary outcome is antibiotic utilization for respiratory conditions measured by a validated quality measure. The study includes data collection on workflow and reach, as well as adoption outcomes, to understand the tests impact and integration into urgent care practice.

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