Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department

University of California (UC) Davis

Status: Completed

Conditions: Influenza, Human

Treatments: Other: Pharmacist-Led Education; Diagnostic Test: Procalcitonin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02899065

906232

Details and patient eligibility

About

This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in aggregate) both the use of the Roche Cobas Liat Flu/RSV Assay and the use of pharmacist-led education for providers in the interpretation of these test results.

Full description

To determine if pharmacist-led education and procalcitonin testing as part of a stewardship intervention optimizes antiviral treatment and reduces antibiotic treatment for pediatric Emergency Department (ED) patients with suspected influenza v. standard care (i.e. rapid molecular influenza test without patient specific treatment recommendations) using a prospective, patient-randomized design.

Consented patients in the pediatric ED will be randomized into two arms: The intervention arm will receive a patient specific stewardship intervention and procalcitonin testing during the ED visit. The intervention will be pharmacist-led and include direct delivery to clinicians of information about interpreting test results and recommendations for antiviral-treatment for high-risk patients, and infection control precautions for patients being hospitalized with a positive RSV or influenza test. Clinician adherence to treatment guidelines with and without the educational intervention will be compared.

The second arm will be usual care (i.e. no procalcitonin test or pharmacist-led education). Results will be delivered via standard of care through the electronic medical record (EMR).

Physicians and patients will not be blinded to arm assignments. Tests will be performed on a real-time basis in the ED. For each of these groups, data of the frequency and duration of antibiotic administration, antiviral use, adherence to evidence based guidelines for treatment of influenza, isolation, hospitalizations, and unscheduled return visits or readmissions within a 30 day period will be collected and compared.

Research coordinators will contact patients and/or parents at 1 and 4 weeks after enrollment for self-reported secondary outcomes including symptom resolution, return to school/work, and follow up healthcare visits, medication adherence (to antibiotics and/or antivirals), and adverse events.

Enrollment: 200 patients

Sex: All

Ages: Under 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients <50 years of age who are evaluated in the emergency department for:
• suspected influenza, including symptoms of influenza-like illness (ILI - including fever > 38 degrees Celsius and cough or sore throat), or
• non-specific upper respiratory infection (URI) for whom the clinician suspects the presence of RSV, or influenza, or lower respiratory infection LRI).
• Patients whose treating provider has ordered a Roche Cobas Liat Flu/RSV test.

Exclusion criteria

• Patients who are pregnant
• Prisoners
• Patients who are unable to give informed consent in English or Spanish.
• Provider is unwilling to wait for procalcitonin results.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention arm will receive pharmacist-led education and stewardship intervention and a procalcitonin test to aid in the decision of how to treat the patient. This intervention will include direct delivery of education from the pharmacist to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.

Treatment:

Diagnostic Test: Procalcitonin

Other: Pharmacist-Led Education

Standard of care

No Intervention group

Description:

The second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care.