Summary

for people ages up to 20 years (full criteria)
at Sacramento, California
study started
estimated completion
Larissa S May, MD

Description

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.

Official Title

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

Details

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.

Keywords

Influenza, Human Emergencies Procalcitonin Pharmacist-Led Education

Eligibility

You can join if…

Open to people ages up to 20 years

  • Patients <21 years of age who are evaluated in the emergency department for:
  • suspected influenza, including symptoms of influenza-like illness (ILI - including fever and cough or sore throat), or
  • non-specific upper respiratory infection (URI) with suspicion for presence of RSV or influenza.
  • Patients whose treating provider has ordered a Roche Cobas Liat Flu/RSV test

You CAN'T join if...

  • Patients who are pregnant
  • Prisoners
  • Patients who are unable to give informed consent in English or Spanish.

Location

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

  • Larissa S May, MD
    Professor, Emergency Medicine. Authored (or co-authored) 16 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT02899065
Study Type
Interventional
Last Updated