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

Not Applicable

Completed

• Conditions: Influenza, Human
• Interventions: Diagnostic Test: Procalcitonin; Other: Pharmacist-Led Education

• Registration Number: NCT02899065
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-14
• Study Start: 2018-03-06
• Primary Completion: 2022-04-15
• Study Completion: 2022-05-20
• Results First Submitted: 2023-06-20
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Results First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pharmacist-Led Education	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.
Intervention	Procalcitonin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Prescribed Antiviral Therapy	During ED stay, up to 48 hours	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.
Number of Participants Prescribed Antibiotics	During ED stay, up to 48 hours	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. Proper adherence to treatment guidelines after results should reduce physician prescription of antibiotic for non-responsive conditions.

Secondary Outcome Measures

Name	Time	Method
Emergency Department Recidivism	30 days	Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV
Lost Days of School/Work	7 days and again at week 4	Number of days of school and/or work missed due to illness
Symptom Resolution	7 days and again at week 4	Time to resolution of symptoms such as fever, cough or sore throat

Trial Locations

Locations (1)

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States