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

Conditions

• Acute Respiratory Infections (ARIs)

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• SPOTFIRE R/ST Diagnostic Test — DEVICE
  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

Study Details

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.

Key Dates

Start date

Dec 22, 2025

Status verified

Feb 2026

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

800 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Intervention
  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. Providers at the intervention site will participate in the AMS and implementation science interventions designed in the pre-implementation phase.
• No Intervention: Control
  At the control site and at the discretion of the treating clinician, patients will have their respiratory samples tested on the clinic's usual standard of care (SOC) respiratory antigen tests, with results used by the treating clinician to guide management. Patients at the control site who meet inclusion and exclusion criteria and agree to participate will also take the CAHPS-based satisfaction survey.

Primary Outcome Measure

Antibiotic utilization for respiratory conditions (HEDIS AXR) [ Time Frame: Day 1 ]

Central Contacts

• Alyssa Duenes
  208-881-2410
  [email protected]
• Andrea Prinzi, PhD
  303-646-7446
  [email protected]

Locations (2)

Find similar trials in Gardendale, AL

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