Impact of Rapid Flu Testing in BMC ED

Study Overview
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Brief Summary
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The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing

Official Title
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Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center

Conditions
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Influenza, Influenza-Like Illness

Intervention / Treatment
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* Other: Core Lab Test
* Other: ED Point of Care Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 21 years of age or older Presenting to the BMC main ED or Urgent Care area with influenza-like illness Physician ordered an influenza A/B diagnostic test Exclusion Criteria: Previously enrolled in the study Any Influenza test result already available at the time approached by the ED RA Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test. Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 21 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Core Lab Testing Arm<br>For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B. | Other: Core Lab Test<br>* For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.<br>|
| Experimental: ED Point of Care Testing Arm<br>Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B. | Other: ED Point of Care Test<br>* For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disposition | The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record | By the End of the ED visit (an average time of 4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery of prescription or administration of antibiotics | Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD | by the end of ED visit (an average time of 4 hours) |