Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway (URGENT): A Randomized Control Trial of Respiratory PCR Versus Standard Care
Phase: NA
Conditions: Viral Infection, Acute Respiratory Infection, Upper Resp Tract Infection
Sponsor: Andrew Meltzer

P a g e  | 1 
 
 
 
 
 
 
 
Study Name:  
 
Urgent Care Management of Respiratory Illness Enabled with Novel Testing Pathway 
(URGENT): A Randomized Control Trial of Respiratory PCR versus Standard Care  
 
 
Date: 30-January-2023 
 
 
NCR: NCR213901 
 
 
Principal Investigator:  
Name:  
 
Andrew C. Meltzer MD, MS 
Title:   
 
Associate Professor of Emergency Medicine 
Institution:  
 
George Washington University 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

P a g e  | 2 
 
 
 
 
Background  
 
Over the past two decades, new options have emerged for patients seeking 
acute care such as urgent care, retail clinics, and telemedicine. While visits to 
emergency departments have declined overall since 2008, urgent care facilities have 
seen a more than 100-fold increase in patient traffic.6 For patients presenting to urgent 
care centers with acute respiratory illness, early and appropriate treatment is essential 
in lessening the disease course and preventing its spread. Acute respiratory illnesses 
account for the largest percentage of urgent care center visits, however diagnosis of the 
specific pathology of the infection is challenging and reliant on traditional diagnostic 
tests and physical exams.7 In evaluating patients for acute respiratory illnesses, clinical 
findings are often nondescript and laboratory testing is needed for definitive diagnosis.1 
Many of the causative agents of acute respiratory illnesses are tested for using antigen 
detection assays.5 While these assays produce results in approximately 10-15 minutes, 
they have relatively poor sensitivity which can lead to missed diagnoses.3 Viral or 
bacterial cultures can also be used to diagnose acute respiratory illnesses, however, 
they take days to produce results which delays initiation of antiviral or antibiotic therapy 
and infection control measures.3  
Rapid diagnosis and precise treatment have become possible with multiplex 
polymerase chain reaction (PCR) panels that can identify a variety of causative agents 
of acute respiratory illnesses such as bacterial and viral infections in one urgent care 
visit.4 While real-time PCR is currently used as a standard for diagnosing acute 
respiratory illnesses such as influenza due to its high sensitivity and specificity, it 
typically takes several hours for results which is unfavorable in the urgent care setting.2 
Highly sensitive and rapid random-access PCR tests provide the sensitivity and 
specificity needed to both rapidly and accurately diagnose acute respiratory illnesses.2 
Similar PCR panels have been used in previous research for the diagnosis of 
gastrointestinal illnesses in the emergency department and point-of-care testing for 
hospitalized adults presenting with acute respiratory illness.1 In this study, we aimed to 
determine if a rapid multiplex PCR test for urgent care patients with symptomatic upper 
respiratory infections can improve patient and provider-reported outcomes. 
Acute respiratory illnesses cause millions of cases per year in the US and result in 
countless hospitalizations, which the current COVID-19 pandemic has greatly inflated. 
Most upper respiratory infections are of viral etiology.7 Rapid diagnostics for acute 
respiratory illnesses in urgent care centers would be highly beneficial in improving both 
patient outcomes and care experiences as well as guiding provider course of care. In a 
2010 study, 33.3% of urgent care center visits were found to be due to upper respiratory 
infections.7 Furthermore, 41.5% of prescriptions written at urgent care facilities were 
found to be for antibiotics.7 Antibiotic overuse for acute respiratory illnesses is partly 
driven by clinical uncertainty regarding underlying etiology.1 With the increasing threat 
of antimicrobial resistance (AMR), accurate and rapid diagnostics will aid in preventing 
unnecessary antibiotic prescribing and promote antimicrobial stewardship.  
Introduction of the rapid testing panels for acute respiratory infections in urgent 
care settings will afford clinicians ease in diagnosing the cause of a patient’s illness 
which will in turn lead to better patient outcomes. This study utilizes the Biofire® 

P a g e  | 3 
 
 
 
 
FilmArray Panel which in previous studies has been shown to be highly effective in 
diagnosing acute respiratory illnesses.  
 
 
Study Objectives:  
Aim 1: To asses improvement in patient-reported outcomes (PRO) in Urgent Care 
patients with acute respiratory illness who are tested with RP2.1 (EXP) versus standard 
care (SC). 
 
Hypotheses: Improvement in PRO’s in group (tested with RP2.1 (EXP) vs. standard 
care (SC)) assessed at Day 0 (i.e., day of test) and/or Day 7 (call-back). 
 
Outcomes 
Primary:  
• Satisfaction with Urgent Care (willingness to recommend urgent care versus 
others). Day 0. 
  
Secondary:  
• Satisfaction with Urgent Care (willingness to recommend urgent care versus 
others). Day 7. 
• Time isolated (or recommended to isolate) by patient. Day 0,7.  
• Time isolated (or recommended to isolate) by family members / close contacts. 
Day 0,7. 
• Understanding of current disease process. Day 0, 7 
• Need for additional diagnostic tests by patient. Day 7. 
• Need for additional diagnostic tests of family members / close contacts. 
Day 7. 
• Missed time at work. Day 7. 
  
Aim 2: To determine the difference in Urgent Care provider-reported outcomes after 
treatment of patients with acute respiratory illness tested with RP2.1 vs. SC. Assessed 
by provider survey. 
 
Hypothesis: Use of RP2.1 will lead to differences in provider-reported outcomes 
assessed at Day 0 compared to SC.  
 
• Confidence in diagnosis 
• Recommendations regarding isolation 
• Ability to address patient needs/ questions. 
• Recommendations regarding disease course. 
• Follow up recommendations 
 
Study Synopsis 
 
Study Design  

P a g e  | 4 
 
 
 
 
Sites 
Two GW Urgent Care sites (McPherson Square, Rhode Island Avenue) - also known as 
Immediate and Primary Care Sites (IPC) 
 
Enrollment times 
7 5 days per week, RA’s screen for relevant chief complaint related to respiratory 
infection.  
 
• (Estimate 5 hours per day = 25 hours / week) at all 3 sites. Therefore, 5 hours x 3 
sites = 15 hours per day. Per week, 15 hours x 7 days / week = 105 hours / week 
• Follow up and survey = 3 hours per day = 21 hours/ week 
• 105 + 21 = 136 RA hours per week 
 
Study Arms 
EXP: RP2.1 result communicated plus scripted communication of meaning of results.  
SC: Standard communication  
 
Outcome Measures 
Day 0   
RA communicates results and assessment of Day 0 relevant patient, provider and 
process outcomes. 
 
Day 7  
Review of EHR (Allscripts, CRISP) 
Patient follow-up assessment performed by phone. 
 
Processing Samples 
Samples will be collected and processed at the three urgent care/immediate primary 
care facilities (IPCs) affiliated with George Washington University Medical Faculty 
Associates.  
 
• Testing will occur on site. Each urgent care performs CLIA-waived lab tests for 
point of care tests.  
 
• Any Non- RP2.1 testing will be allowed in either group per discretion of the 
provider.  
 
• Standardize script for communication of results provided on same day as testing 
to providers.  
 
Standard care 
Most patients with symptoms of a respiratory illness receive testing for COVID-
19. The process for suspected COVID is to run a SARS antigen test initially. Results of 
the antigen tests are available within 15 to 20 minutes.  For anyone with a negative test, 
samples are then sent to LabCorp for a confirmatory PCR test.  The results of the PCR 
test are dependent on the number of tests LabCorp is performing but typically take 

P a g e  | 5 
 
 
 
 
between 24 to 96 hours.  All patients with results that are positive receive a phone call; 
for patients with a negative test, no call is made and patients must access the patient 
portal to get results.   
 
Our expectation is that the use of RP2.1 will lead to improved satisfaction for 
patient and provider.   
 
Inclusion Criteria 
• Age 7-year-old 
• Clinically stable  
• Must present with one symptom of respiratory illness (e.g., cough, sneezing, 
runny or stuffy nose, sore throat, headaches, muscle aches, trouble breathing, 
shortness of breath, and/or fever). 
 
Exclusion criteria   
• Patient is unable to provide informed consent 
• Chronic symptoms (>14 days) or asymptomatic 
• Unstable (or “too sick” to consent) 
• Prisoner or ward of state 
• Non-English speaker 
 
Potential barriers and solutions 
• Success for the study requires provider buy-in to aid with recruitment efforts.  
Lack of provider buy-in may hinder sample size ascertainment. Proposed 
solutions include electronic alerts, incentive payments, and communication aids 
to physicians to discuss results with patients.   
• Successful undertaking of this study requires dedicated research staff to ensure 
high recruitment goals and fidelity to protocol. We have budgeted for a study 
coordinator with 25% effort allocated directly to the project in addition to 136 
hours of research assistant time per week. We currently have several trained 
research assistants who will be assigned to this study allowing for rapid 
implementation of study.  
 
Data Analysis and Statistical plan 
We anticipate that we will enroll 30 patients per week for 12 weeks, 360 patients. (Full 
power analysis still forthcoming,) 
 
Data Collection 
• Standard demographic information  
• vaccination status 
• insurance status 
• QOL measures 
• health literacy level 
• current symptomatology 
• vital signs 

P a g e  | 6 
 
 
 
 
• CPT  
• ICD-10 codes 
 
Analysis 
Dr. Yan Ma, professor of Biostatistics and Bioinformatics at George Washington 
University, will be our statistician for this project. He has aided in data analysis for 
previous projects affiliated with BioFire with Dr. Meltzer.  
 
Communication 
• Progress reports will be prepared every three months from study initiation to 
completion, including presentation or publication of the study results. 
 
Anticipated start date 
• November 2021 
 
Anticipated duration of the study? 
• November 2021-February September 2022 (3 months for study enrollment) 
• March 2022-May 2022 (3 months for Data Analysis and Manuscript Preparation)  
 
IRB/Ethics Board Requirements and Status 
 
• Is IRB/Ethics Board Approval Required?  (Please provide a justification if 
approval is not required)/ Yes 
 
• Does the study require informed consent?   Yes 
 
• What is the current status of the approval? Note: A copy of the IRB/Ethics 
Committee decision regarding the study must be provided prior to study initiation. 
 
• Currently under review through George Washington University’s IRB. 
 
Requested Support 
 
We request three rapid testing machines and enough cartridges for a minimum of 360 
tests.  
 
 
REFERENCES 
1. Beard K, Brendish N, Malachira A, et al. Pragmatic Multicentre randomised 
controlled trial evaluating the impact of a routine molecular point-of-care ‘test-
and-treat’ strategy for influenza in adults hospitalised with acute respiratory 
illness (flupoc): Trial protocol. BMJ Open. 2019;9(12). doi:10.1136/bmjopen-
2019-031674  

P a g e  | 7 
 
 
 
 
2. Dugas AF, Valsamakis A, Atreya MR, et al. Clinical diagnosis of influenza in the 
ed. The American Journal of Emergency Medicine. 2015;33(6):770-775. 
doi:10.1016/j.ajem.2015.03.008  
3. Kim D-K, Poudel B. Tools to detect influenza virus. Yonsei Medical Journal. 
2013;54(3):560. doi:10.3349/ymj.2013.54.3.560  
4. Leber AL, Everhart K, Daly JA, et al. Multicenter evaluation of BioFire FilmArray 
Respiratory Panel 2 for detection of viruses and bacteria in nasopharyngeal swab 
samples. Journal of Clinical Microbiology. 2018;56(6). doi:10.1128/jcm.01945-17  
5. Overview of influenza testing methods. Centers for Disease Control and 
Prevention. https://www.cdc.gov/flu/professionals/diagnosis/overview-testing-
methods.htm. Published August 31, 2020. Accessed October 12, 2021.  
6. Poon SJ, Schuur JD, Mehrotra A. Trends in visits to acute care venues for 
treatment of low-acuity conditions in the United States from 2008 to 2015. JAMA 
Internal Medicine. 2018;178(10):1342. doi:10.1001/jamainternmed.2018.3205  
7. Weinick RM, Burns RM, Mehrotra A. Many emergency department visits could be 
managed at Urgent Care Centers and retail clinics. Health Affairs. 
2010;29(9):1630-1636. doi:10.1377/hlthaff.2009.0748