The purpose of this study is to evaluate where urgent care (UC) clinicians see the most benefit for a novel, point of care pharyngitis test, SPOTFIRE ST, and describe its performance, potential clinical utility, and satisfaction of providers and patients with this novel test. Up to 200 participants will be on study for up to approximately 25 minutes.
The broader study is separated into three specific aims. AIM 1. Evaluate which specific patient populations UC providers see the most need and benefit from SPOTFIRE ST, a multiplex point of care pharyngitis test. AIM 2. Evaluate the performance and effects of test results associated with important clinical outcomes (e.g., prescriptions, additional testing, disposition and follow-up) for patients in the top 3-4 high-risk subpopulations identified by providers in Specific AIM 1. AIM 3. Evaluate patient and provider satisfaction and future use opportunities of the SPOTFIRE ST Panel testing platform in the clinical pathway for evaluating patients with pharyngitis in UC centers. AIMS 2-3 are registered to this ClinicalTrials.gov record.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes
UW Health Urgent Care Centers
Madison, Wisconsin, United States
Aim 2 Clinical Outcome: Summary of test results
SPOTFIRE ST results by count.
Time frame: up to 20 minutes
Aim 2 Clinical Outcome: Number of Participants with follow up testing
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 3: Participant Satisfaction Survey
Participant Satisfaction will be measured using a self-report survey scored from 0-10 where higher scores indicate increased satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey
Provider Satisfaction will be measured using a self-report survey scored from 0-10 where higher scores indicate increased satisfaction with the testing experience.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Utility Survey
Providers will be surveyed to learn how they might use the SPOTFIRE test in the future. Survey responses will be ranked and reported by response rate.
Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
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