Evaluation of the Roche Cobas Liat Flu/Respiratory Syncytial Virus (RSV) Assay for Management of Influenza in the Emergency Department (Influenza)
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|ClinicalTrials.gov Identifier: NCT02899065|
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Diagnostic Test: Procalcitonin Other: Pharmacist-Led Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department|
|Actual Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
Diagnostic Test: Procalcitonin
Procalcitonin is a blood test used to differentiate between viral and bacterial infections. This test is expected to aid in determining the best course of treatment for patients enrolled into this arm.
Other: Pharmacist-Led Education
Pharmacists will interpret the results of the Roche Cobas Liat Flu/RSV assay and procalcitonin test (if available) and provide the treating physician with recommendations for antibiotic therapy based on these results.
No Intervention: Standard of care
The second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care.
- Treatment guideline adherence as measured by physician prescription of antibiotic non-responsive conditions [ Time Frame: Immediate ]The determination of whether use of the Roche Cobas/Liat Flu/RSV Assay as part of a stewardship intervention reduces antibiotic treatment for pediatric ED patients with suspected influenza.
- Antiviral treatment for patients with influenza like illness at risk of complications [ Time Frame: immediate ]The determination of whether use of the Roche Cobas Liat Flu/RSV Assay as part of a formal stewardship intervention optimizes antiviral treatment of pediatric ED patients with influenza at risk of complications
- Physician adherence to Centers for Disease Control and Prevention (CDC) guidelines for treatment of influenza as measured by prescription of anti-viral treatment for patients in whom it is indicated. [ Time Frame: 2 years ]The investigators will monitor physician prescription of anti-viral therapy according to CDC guidelines, which would recommend anti-viral treatment of patients who will be hospitalized with complicated illness, patients who will be discharged home from the Emergency Department but are at increased risk for complications, and patients in whom test results would indicate appropriateness of anti-viral therapy.
- Emergency Department recidivism [ Time Frame: 30 days ]Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV
- Symptom resolution [ Time Frame: 30 days ]Time to resolution of symptoms such as fever, cough or sore throat
- Lost days of school/work [ Time Frame: 30 days ]Number of days of school and/or work missed due to illness
- Healthcare burden as measured by the number of healthcare visits after discharge from the Emergency Department [ Time Frame: 30 days ]Subsequent healthcare utilization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899065
|Contact: Larissa S. May, MDemail@example.com|
|Contact: Cindy V. Valencia, MPHfirstname.lastname@example.org|
|Principal Investigator:||Larissa S May, MD||University of California, Davis|