Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway

Acute Respiratory Infection Clinical Trial

— URGENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467007
• Other study ID #: NCR213901
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Upper Resp Tract Infection
• Viral Infection
• Virus Diseases

Intervention

Diagnostic Test:
• BioFire® Respiratory Panel 2.1-EZ
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.

Locations

Country	Name	City	State
United States	GW Immediate & Primary Care - McPherson Square	Washington	District of Columbia
United States	GW Immediate & Primary Care - Rhode Island Ave	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Meltzer	BioMérieux

Country where clinical trial is conducted

United States, 

References & Publications (7)

Beard K, Brendish N, Malachira A, Mills S, Chan C, Poole S, Clark T. 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 Dec 17;9(12):e031674. doi: 10.1136/bmjopen-2019-031674. — View Citation

Dugas AF, Valsamakis A, Atreya MR, Thind K, Alarcon Manchego P, Faisal A, Gaydos CA, Rothman RE. Clinical diagnosis of influenza in the ED. Am J Emerg Med. 2015 Jun;33(6):770-5. doi: 10.1016/j.ajem.2015.03.008. Epub 2015 Mar 12. — View Citation

Kim DK, Poudel B. Tools to detect influenza virus. Yonsei Med J. 2013 May 1;54(3):560-6. doi: 10.3349/ymj.2013.54.3.560. — View Citation

Leber AL, Everhart K, Daly JA, Hopper A, Harrington A, Schreckenberger P, McKinley K, Jones M, Holmberg K, Kensinger B. Multicenter Evaluation of BioFire FilmArray Respiratory Panel 2 for Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples. J Clin Microbiol. 2018 May 25;56(6):e01945-17. doi: 10.1128/JCM.01945-17. Print 2018 Jun. — View Citation

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.

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 Intern Med. 2018 Oct 1;178(10):1342-1349. doi: 10.1001/jamainternmed.2018.3205. — View Citation

Weinick RM, Burns RM, Mehrotra A. Many emergency department visits could be managed at urgent care centers and retail clinics. Health Aff (Millwood). 2010 Sep;29(9):1630-6. doi: 10.1377/hlthaff.2009.0748. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction With Urgent Care	Willingness to recommend urgent care versus others, conducted via survey	Day of enrollment
Secondary	Satisfaction With Urgent Care	Willingness to recommend urgent care versus others, conducted via follow-up phone call survey	Day 7 after enrollment
Secondary	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 7 after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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