Clinical trial NCT06765135: Point of Care Respiratory Pathogen Testing for Antibiotic Stewardship in Primary Care
Official title: Point of Care Respiratory Pathogen Testing for Antibiotic Stewardship in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Upper Respiratory Infection
Keywords: upper respiratory infections
primary care clinics
point of care testing
antibiotic stewardship
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The goal of this study is to understand the use of point of care (POC) testing devices in primary care offices to help clinicians diagnose and appropriately treat patients who have symptoms of upper respiratory infections (URIs).

The study will use the BIOFIRE® SPOTFIRE® Respiratory (R) Panel testing device, which is FDA-cleared and CLIA-Waived. This panel can identify up to 15 different viruses and bacteria that can cause URIs.

These POC devices will be installed in primary care clinics within the University of Pennsylvania Health System. Patients who come to the clinic with cold-like symptoms (runny nose, cough) will be offered the test. If the patient agrees to the test, their clinician will use a swab to take a small sample of fluid from their nose. This swab will then be tested within the POC device and results will be available within 15 minutes.

The results of this sample will be shared with the patient, and their clinician can use the results to help decide the most appropriate medical treatment for the patient.

Patients who agree to take the test will be asked to answer a short survey about the test and their experience. Clinicians will also be surveyed to share their thoughts with using the test in their clinics. Focus groups of practice staff and clinicians will also be conducted to understand any potential challenges for using this test in practice.

Results from the tests and the surveys will help researchers understand the value of the test to support antibiotic stewardship efforts in primary care clinic settings.

Detailed description: Point of care (POC) testing for respiratory viral pathogens has been proposed as a potential tool for use in antibiotic stewardship in primary care, particularly with reducing diagnostic uncertainty and supporting providers in communication about upper respiratory symptom etiology. However, there are limited data to support their widespread use. The research team propose to conduct a study that seeks to understand the role of POC respiratory pathogen testing on antibiotic prescribing in primary care practices. The research team plan to use qualitative methods, including focus groups and surveys of primary care clinicians to understand provider perceptions of POC respiratory pathogen testing (part 1). The research team will then perform a pragmatic, stepped-wedge, cluster randomized trial in 4-8 primary care practices to study the impact of implementation of the POC respiratory pathogen testing, using the Spotfire R panel, on antibiotic prescribing (part 2). The results from part 1 of the study will be used to optimize implementation in part 2 of the study. The research team will also assess several secondary outcomes in part 2, including antiviral prescribing, healthcare utilization, and patient and provider perceptions of the use of POC respiratory pathogen testing.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* Symptoms of an upper respiratory infection to include: cough, rhinorrhea, nasal congestion, fever, sore throat, ear pain/fullness, sinus pain

Exclusion Criteria:

* Age \< 18 years of age
* No relevant upper respiratory symptoms

Primary outcomes:
measure: Antibiotic prescription at index visit
timeFrame: From participant enrollment to end of index visit
Secondary outcomes:
measure: Provider attitudes and perceptions toward point of care respiratory pathogen testing
timeFrame: Two months following completion of study intervention
measure: Patient attitudes and perceptions toward point of care respiratory pathogen testing
timeFrame: From participant enrollment to two weeks after index visit
measure: Antiviral prescription at index visit
timeFrame: From participant enrollment to end of index visit
measure: Antibiotic prescription at index visit for specific subgroups, including patients with specific diagnoses (sinusitis, acute bronchitis, acute pharyngitis) and patients with ICD-10 codes for diagnoses for which an antibiotic is typically not warranted
timeFrame: From participant enrollment to end of index visit
measure: Healthcare utilization, to include: 1. Follow up visits within 14 days after the index visit 2. Follow up telephone calls and messages within 14 days after the index visit 3. Antibiotic or antiviral prescriptions within 14 days after the index visit
timeFrame: From participant enrollment to 14 days after index visit
measure: Test utilization, to include use of Spotfire R panel
timeFrame: From participant enrollment to 14 days after index visit
measure: Test utilization, to include laboratory-based respiratory pathogen testing
timeFrame: From participant enrollment to 14 days after index visit
measure: Test utilization, to include Group A streptococcal testing
timeFrame: From participant enrollment to 14 days after index visit
measure: Test utilization, to include chest imaging
timeFrame: From participant enrollment to 14 days after index visit
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Primary Care Practice
state: Pennsylvania
Study officials:
References: