Influenza, Influenza-Like Illness
Conditions
Brief summary
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
Interventions
OTHERCore Lab Test
For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.
OTHERED Point of Care Test
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
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disposition | By the End of the ED visit (an average time of 4 hours) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery of prescription or administration of antibiotics | by the end of ED visit (an average time of 4 hours) | Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD |
Countries
United States
Outcome results
None listed