Point of Care Respiratory Pathogen Testing for Antibiotic Stewardship in Primary Care (PROTECT)

University of Pennsylvania

Status: Invitation-only

Conditions: Upper Respiratory Infection

Treatments: Behavioral: Patient Survey; Diagnostic Test: Biofire Spotfire Respiratory (R) panel; Behavioral: Focus Group; Behavioral: Clinician Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT06765135

856091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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8,000 participants in 2 patient groups

Clinicians/practice staff

Other group

Description:

Clinicians will be the target for the intervention that will include provision of the POC RPP (Point of Care Respiratory Pathogen Panel) test as well as clinical guidance on use and interpretation. Clinicians will also be included in focus groups and surveys, and other administrative practice staff will also be included in focus groups. All clinicians/staff practicing at one of the included practices will be eligible for inclusion

Treatment:

Behavioral: Clinician Survey

Diagnostic Test: Biofire Spotfire Respiratory (R) panel

Behavioral: Focus Group

Patients

Other group

Description:

All adult patients (age \>=18 years) at one of the included primary care practices seen for an upper respiratory infection or symptom will be included in the primary study analysis, as identified by ICD-10 code (from baseline and intervention periods). Patients with ICD-10 codes for other bacterial infections at the same encounter will be excluded (e.g., skin and soft tissue infection) from the analysis. During the intervention period, adult patients with symptoms potentially suggestive of an upper respiratory infection will be eligible for use of the POC RPP test.

Treatment:

Diagnostic Test: Biofire Spotfire Respiratory (R) panel

Behavioral: Patient Survey