Clinical trial NCT02899065: Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
Official title: Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2016-09-14
Enrollment: 200
Sex: ALL
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Prescribed Antibiotics
timeFrame: During ED stay, up to 48 hours
measure: Number of Participants Prescribed Antiviral Therapy
timeFrame: During ED stay, up to 48 hours
Secondary outcomes:
measure: Emergency Department Recidivism
timeFrame: 30 days
measure: Symptom Resolution
timeFrame: 7 days and again at week 4
measure: Lost Days of School/Work
timeFrame: 7 days and again at week 4
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Larissa S May, MD
role: PRINCIPAL_INVESTIGATOR
References: