Point of Care Respiratory Pathogen Testing for Antibiotic Stewardship in Primary Care

NCT ID: NCT06765135

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-01-31

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.

Conditions

Upper Respiratory Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clinicians/practice staff

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

Group Type: OTHER

Clinician Survey

Intervention Type: BEHAVIORAL

At the conclusion of the intervention period, practice stakeholders, including survey providers and practice managers in the intervention sites will be surveyed to identify their degree of satisfaction with the intervention and suggestions for improvement.

Focus Group

Intervention Type: BEHAVIORAL

Prior to installing the device in each primary care practice, trained moderators will conduct focus groups with clinicians and practice staff to to elicit provider perceptions of POC testing for respiratory pathogens, including feasibility and acceptability of integration of testing into routine workflows.

Biofire Spotfire Respiratory (R) panel

Intervention Type: DIAGNOSTIC_TEST

Eligible patients will be offered testing with the BioFire Spotfire Respiratory (R) Panel, which is an FDA-cleared, CLIA waived test. This is a multiplexed polymerase chain reaction (PCR) test intended for use with the BioFire Spotfire System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal (NP) swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. This testing will be made available in participating practices along with clinical guidance about use and interpretation. Clinicians will administer the tests to patients who agree to be tested. Results will be shared with patients, who can discuss the results with their clinicians. Clinicians can use the test results to guide their treatment decisions.

Patients

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.

Group Type: OTHER

Biofire Spotfire Respiratory (R) panel

Intervention Type: DIAGNOSTIC_TEST

Eligible patients will be offered testing with the BioFire Spotfire Respiratory (R) Panel, which is an FDA-cleared, CLIA waived test. This is a multiplexed polymerase chain reaction (PCR) test intended for use with the BioFire Spotfire System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal (NP) swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. This testing will be made available in participating practices along with clinical guidance about use and interpretation. Clinicians will administer the tests to patients who agree to be tested. Results will be shared with patients, who can discuss the results with their clinicians. Clinicians can use the test results to guide their treatment decisions.

Patient Survey

Intervention Type: BEHAVIORAL

During the intervention period, patients who undergo POC RPP testing will be surveyed soon after their visit to elicit their opinions about the test.

Interventions

Clinician Survey

At the conclusion of the intervention period, practice stakeholders, including survey providers and practice managers in the intervention sites will be surveyed to identify their degree of satisfaction with the intervention and suggestions for improvement.

Intervention Type: BEHAVIORAL

Focus Group

Prior to installing the device in each primary care practice, trained moderators will conduct focus groups with clinicians and practice staff to to elicit provider perceptions of POC testing for respiratory pathogens, including feasibility and acceptability of integration of testing into routine workflows.

Intervention Type: BEHAVIORAL

Biofire Spotfire Respiratory (R) panel

Eligible patients will be offered testing with the BioFire Spotfire Respiratory (R) Panel, which is an FDA-cleared, CLIA waived test. This is a multiplexed polymerase chain reaction (PCR) test intended for use with the BioFire Spotfire System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal (NP) swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. This testing will be made available in participating practices along with clinical guidance about use and interpretation. Clinicians will administer the tests to patients who agree to be tested. Results will be shared with patients, who can discuss the results with their clinicians. Clinicians can use the test results to guide their treatment decisions.

Intervention Type: DIAGNOSTIC_TEST

Patient Survey

During the intervention period, patients who undergo POC RPP testing will be surveyed soon after their visit to elicit their opinions about the test.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Lauren Dutcher

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania Primary Care Practice

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

856091

Identifier Type: -

Identifier Source: org_study_id