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

NCT06765135 | Enrolling By Invitation

• 1 other identifier: 856091
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Infection

Keywords

upper respiratory infections; primary care clinics; point of care testing; antibiotic stewardship

Outcome Measures

Primary Outcomes (1)

• Antibiotic prescription at index visit

  Proportion of patients with an antibiotic prescribed at the index visit

  From participant enrollment to end of index visit

Secondary Outcomes (9)

• Provider attitudes and perceptions toward point of care respiratory pathogen testing

  Two months following completion of study intervention

• Patient attitudes and perceptions toward point of care respiratory pathogen testing

  From participant enrollment to two weeks after index visit

• Antiviral prescription at index visit

  From participant enrollment to end of index visit

• 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

  From participant enrollment to end of index visit

• 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

  From participant enrollment to 14 days after index visit

Study Arms (2)

Clinicians/practice staff

OTHER

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

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

Patients

OTHER

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.

Diagnostic Test: Biofire Spotfire Respiratory (R) panel; Behavioral: Patient Survey

Interventions

Clinician Survey 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.

Clinicians/practice staff

Focus Group 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.

Clinicians/practice staff

Patient Survey 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.

Patients

Biofire Spotfire Respiratory (R) panel 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.

Clinicians/practice staff; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Primary Care Practice

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 9, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

US (1)