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 (preparatory for the clinical trial, included here for context only). 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: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results
Data collected via electronic medical record review 3 weeks post study visit.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results
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: Participants With Treatable Pathogens
SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit. Treatable Pathogens include: Influenza A or B (FluA/B), Group A Strep (GAS), Mycoplasma pneumoniae (Mpn), Chlamydia pneumoniae (Cpn)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 3 weeks
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics
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 for 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 approximately 4 months)
Aim 3: Participant Satisfaction Survey - How do the Results Feel?
Participant Satisfaction will be measured using a self-report survey for 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: Participant Satisfaction Survey - Are You Satisfied With the Test Result?
Participant Satisfaction will be measured using a self-report survey for 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: Participant Satisfaction Survey - Are You Satisfied With Provider Information?
Participant Satisfaction will be measured using a self-report survey for 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: Participant Satisfaction Survey - Are You Satisfied With the Treatment?
Participant Satisfaction will be measured using a self-report survey for 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: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?
Participant Satisfaction will be measured using a self-report survey for 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: Participant Satisfaction Survey - Likelihood to do Test Again?
Participant Satisfaction will be measured using a self-report survey for 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. Providers were asked to rank each patient population from 1-7, a nominal point value was given for this ranking to generate the scores (rank of 1=1, rank of 2=2, etc.) Lower scores indicate higher (more important) ranking. Mean rank score for each patient population is reported here to give the reader an idea of how important each item was for the group of providers.
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 - How Often Test Used?
Provider Satisfaction will be measured using a self-report survey to indicate 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 - Ease of Fitting Into Workflow?
Provider Satisfaction will be measured using a self-report survey to indicate 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 - How Prepared Did You Feel to Answer Questions About Test?
Provider Satisfaction will be measured using a self-report survey to indicate 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 -Test Differed From Initial Clinical Impression?
Provider Satisfaction will be measured using a self-report survey to indicate 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 - How Useful Was the Test?
Provider Satisfaction will be measured using a self-report survey to indicate 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 - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?
Provider Satisfaction will be measured using a self-report survey to indicate 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 - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?
Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience. Prescription for Antibiotics or Antivirals (Rx Abx/AV)
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 - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?
Provider Satisfaction will be measured using a self-report survey to indicate 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 - When do You Think it Would be Best to Test Patients With SPOTFIRE?
Provider Satisfaction will be measured using a self-report survey to indicate 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)