Impact of Rapid Flu Testing in BMC ED

Influenza Clinical Trial

— FluProcess  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979730
• Other study ID #: H-35841
• Status: Completed
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Influenza-Like Illness

Intervention

Other:
• Core 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.
• ED 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

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)