Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway

Study Overview
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Brief Summary
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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. 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. Highly sensitive and rapid random-access PCR tests provide the sensitivity and specificity needed to both rapidly and accurately diagnose acute respiratory illnesses. 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. In this study, the investigators aim to determine if a rapid multiplex PCR test for urgent care patients with symptomatic upper respiratory infections can improve patient and provider-reported outcomes. This study utilizes the Biofire® FilmArray Panel (RP2.1-EZ) which in previous studies has been shown to be highly effective in diagnosing acute respiratory illnesses.

Detailed Description
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Research assistants in the IPCs will screen for possible participants by searching the electronic health record for complaints and/or symptoms of respiratory illness. Patients who screen eligible will be approached about potential interest, review inclusion and exclusion criteria, and obtain informed consent. All consented patients will be given a study ID and recorded in enrollment log. Patients who consent will be randomized to one of the two groups: BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ; EXP) versus standard care (SC). The RP2.1-EZ panel is designed to test for a variety of bacterial and/or viral causes for illness whereas standard care procedures are essentially yes/no to patient having SARS-COV-2. Both groups will receive a nasal swab, however, the EXP group will receive the BioFire RP2.1-EZ panel, and the SC group will receive the standard nasal swab used in the IPCs. As the RP2.1-EZ panel includes SARS-COV-2, patients in the EXP group need not receive two separate nasal swabs. Nasal swabs will be performed for both groups, ideally during triage, however, the sample may be collected any time during the visit, by staff trained by BioFire Diagnostics LLC. After the nasal swab is collected, it will be either sent to LabCorp (SC) or tested on site (EXP). On site testing of samples for EXP arm will occur in the same IPC room where rapid COVID-19 tests are tested. EXP panel results should be processed within 45 minutes to 1 hour but will be communicated to patient at COB (see below). Results will be communicated to both the patient and the health care provider as soon as possible, typically on the same day as enrollment. The research team will explain the results using a standarization script written by medical professionals. If patients have further questions, they will be referred to their healthcare provider. The usage of the RP EZ-2.1 Panel will guide the managemnet of providers in the following ways: more focused advice on time to isolate and/or quartine for patients, focused advice regarding infectivity, identifying the natural course of disease faster, guiding anti-biotic decisions for providers, and helping providers identify potential anti-viral therapy in a faster manner. Patient data will be collected regarding demographics (Form D), comorbidities (Form D), nature of current symptoms (Form D), vaccination status (Form D), quality of life measures (Form E), vital signs at triage (Form F), CPT and ICD-10 codes (Form D), and travel history (Form D). This will be collected after the nasal swab is collected before the patient leaves the clinic. Patients will complete this form on a password protected iPad through secure REDCAP survey in a private, patient room. Patients will receive their results at the end of the day via follow up phone call by the research assistants (RAs) if randomized to the EXP group. If randomized to the SC group, patients will receive their results within 24-72 hours, dependent on turn around time at LabCorp. RAs will be providing results to both patients and providers. Providers can opt to complete a brief questionnaire (i.e., five minutes or less) regarding how their course of treatment was affected by the results. RAs will call patients to complete a brief satisfaction survey (15 minutes) with their results (if available) and uploaded results can be found in patient's electronic health record. Standardized scripts written by medical professionals will be used to provide diagnostic feedback for both patient groups via phone. Research assistants will provide diagnostic feedback to the providers in person for the EXP group. Clinician ordered testing (if any) can occur at any time and will be reported per usual protocol. If testing comes back positive for a bacterial/viral pathogen for EXP arm or SARS-COV-2 for SC arm, participants be referred to their health care provider if they want to seek further treatment or have questions about results. This is not inconsistent with the standard practices now happening at the IPCs. The study coordinator or trained research assistants will follow up with all enrolled patients at 7 business days to evaluate the course of symptoms, assess patient satisfaction, and to assess other relevant medical information.

Official Title
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Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway (URGENT): A Randomized Control Trial of Respiratory PCR Versus Standard Care

Conditions
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Viral Infection, Acute Respiratory Infection, Upper Resp Tract Infection

Intervention / Treatment
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* Diagnostic Test: BioFire® Respiratory Panel 2.1-EZ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >7 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

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 to 1 RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioFire® Respiratory Panel 2.1-EZ<br>EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness | Diagnostic Test: BioFire® Respiratory Panel 2.1-EZ<br>* BioFire RP2.1-EZ Panel uses a syndromic approach to quickly identify SARS-CoV-2, along with 18 additional viral and bacterial pathogens in patients suspected of SARS-CoV-2. This PCR test provides results in about 45 minutes.<br>|
| No Intervention: Standard of Care<br>Standard care procedures are essentially yes/no to patient having SARS-COV-2, the SC group will receive the standard nasal swab used in the IPCs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Urgent Care | Willingness to recommend urgent care versus others, conducted via survey | Day of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Urgent Care | Willingness to recommend urgent care versus others, conducted via follow-up phone call survey | Day 7 after enrollment | 
| Time isolated or Recommended to Isolate | The amount of time participants had to isolate or were recommended to isolate following their visit to the urgent care clinic. | Day 0 and Day 7 after enrollment | 
| Time isolated or Recommended to Isolate by family members / close contacts | The amount of time participants family members and close friends were to isolate or were recommended to isolate following the respective members visit to the urgent care clinic. | Day 0 and Day 7 after enrollment | 
| Understanding of current disease process | How confident the participant is in understanding what is causing their respective illness following testing at the urgent care. | Day 0 and Day 7 after enrollment | 
| Need for additional diagnostic tests by patient | Did the participant return for following up testing within 7-days of their enrollment, determined via follow up phone call at 7-days | Day 7 after enrollment | 
| Need for additional diagnostic tests by participants family members / close contacts | Did the participants family members / close contacts receive testing within 7-days of the participants enrollment, determined via follow up phone call at 7-days | Day 7 after enrollment | 
| Missed time at work or school | Did the participant miss work or school due to their testing results determined at day 0 | Day 7 after enrollment |