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.
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
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
Parallel
SPOTFIRE R/ST Diagnostic Test
DeviceAt 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
Antibiotic utilization for respiratory conditions (HEDIS AXR)
The percent of episodes for patients one year and older with a diagnosis of a respiratory condition that results in an antibiotic prescribing event. (Note: while the HEDIS measure includes all patients greater than 3 months of age, AFC's electronic health record (EHR) stores age as whole years. Excluding patients with a reported age of 0 from the baseline data resulted in only 0.03% of observations lost.)
Effectiveness outcome
This study employs a pre-post design with a difference-in-differences (DID) analysis to estimate the treatment effect of implementing the Spotfire R/ST assay paired with training and education. The DID approach compares changes in outcomes over time between the intervention and control groups, accounting for baseline differences and secular trends. The DID model will estimate the causal effect of the intervention (Spotfire) using an interaction term between time (pre- vs. post-intervention) and treatment group (Spotfire vs. standard of care): Y=β0+β1\[Time\]+β2\[Intervention\]+β3\[Time\*Intervention\]+β4\[Covariates\]+ϵ
Percentage of episodes for patients one year and older with a diagnosis of acute bronchitis/bronchiolitis that did not result in an antibiotic prescribing event
The percentage of episodes that were not prescribed an antibiotic
Percentage of episodes for members 3 years of age and older with a diagnosis of pharyngitis, dispensed an antibiotic and received a group A streptococcus test for the episode (HEDIS CWP)
Percentage of episodes for patients 3 years of age or older with a positive Group A Strep (GAS) test and prescribed an antibiotic
