Influenza, Human
Conditions
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.
Interventions
DIAGNOSTIC_TESTProcalcitonin
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.
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.
Sponsors
Roche Pharma AG
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Recidivism | 30 days | Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV |
| Symptom Resolution | 7 days and again at week 4 | Time to resolution of symptoms such as fever, cough or sore throat |
| Lost Days of School/Work | 7 days and again at week 4 | Number of days of school and/or work missed due to illness |
Countries
United States
Participant flow
Recruitment details
Participants were recruited after presentation to the Emergency Department between March 2018 and April 2022 at the University of California Davis Medical Center.
Pre-assignment details
During the enrollment period, 1259 ED patients were assessed for inclusion and 200 were randomized into the research study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship 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. | 100 |
| Standard of Care This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Day 7 to 4 Week Follow Up Contact | Lost to Follow-up | 21 | 16 |
| Day 7 to 4 Week Follow Up Contact | Withdrawal by Subject | 3 | 0 |
| Randomization to 7 Day Follow Up Contact | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Intervention Arm | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 149 months STANDARD_DEVIATION 157 | 136 months STANDARD_DEVIATION 149 | 124 months STANDARD_DEVIATION 140 |
| Education - n = Some college | 16 Participants | 27 Participants | 11 Participants |
| Height | 50.5 inches STANDARD_DEVIATION 16.5 | 50.7 inches STANDARD_DEVIATION 15.7 | 50.8 inches STANDARD_DEVIATION 14.9 |
| Influenza A positive | 13 Participants | 24 Participants | 11 Participants |
| Influenza B positive | 8 Participants | 13 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 49 Participants | 95 Participants | 46 Participants |
| Region of Enrollment United States | 100 participants | 200 participants | 100 participants |
| Respiratory syncytial virus - RSV positive | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Female | 44 Participants | 91 Participants | 47 Participants |
| Sex: Female, Male Male | 56 Participants | 109 Participants | 53 Participants |
| Temperature | 37.7 celsius STANDARD_DEVIATION 1.1 | 37.6 celsius STANDARD_DEVIATION 1 | 37.6 celsius STANDARD_DEVIATION 1 |
| Weight | 40.0 kilograms STANDARD_DEVIATION 33.7 | 39.3 kilograms STANDARD_DEVIATION 34.1 | 38.7 kilograms STANDARD_DEVIATION 34.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Number of Participants Prescribed Antibiotics
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.
Time frame: During ED stay, up to 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Participants Prescribed Antibiotics | 39 Participants |
| Standard of Care | Number of Participants Prescribed Antibiotics | 32 Participants |
Primary
Number of Participants Prescribed Antiviral Therapy
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.
Time frame: During ED stay, up to 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Participants Prescribed Antiviral Therapy | 12 Participants |
| Standard of Care | Number of Participants Prescribed Antiviral Therapy | 10 Participants |
Secondary
Emergency Department Recidivism
Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV
Time frame: 30 days
Population: Number of participants who tested positive during their initial ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Emergency Department Recidivism | 19 Participants |
| Standard of Care | Emergency Department Recidivism | 16 Participants |
Secondary
Lost Days of School/Work
Number of days of school and/or work missed due to illness
Time frame: 7 days and again at week 4
Population: The total participants randomized in the study was 200 with an equal number in both arms (100). Of the 100 participants randomized to each arm, only 87 were able to be contacted in the intervention arm and 82 participants in the standard of care arm at Day 7. At week 4, 76 participants were able to be contacted in the intervention arm and 77 were contacted in the standard of care arm. The remaining participants were either lost to follow up or withdrew consent for participation in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Lost Days of School/Work | School days missed at day 7 | 2.6 Days | Standard Deviation 3 |
| Intervention Arm | Lost Days of School/Work | Work days missed at day 7 | 2.5 Days | Standard Deviation 2.7 |
| Intervention Arm | Lost Days of School/Work | School days missed at week 4 | 1.8 Days | Standard Deviation 3.7 |
| Intervention Arm | Lost Days of School/Work | Work days missed at week 4 | 0.9 Days | Standard Deviation 1.7 |
| Standard of Care | Lost Days of School/Work | Work days missed at week 4 | 1.2 Days | Standard Deviation 3.6 |
| Standard of Care | Lost Days of School/Work | School days missed at day 7 | 2.6 Days | Standard Deviation 3.1 |
| Standard of Care | Lost Days of School/Work | School days missed at week 4 | 1.4 Days | Standard Deviation 4.1 |
| Standard of Care | Lost Days of School/Work | Work days missed at day 7 | 3.1 Days | Standard Deviation 3.1 |
Secondary
Symptom Resolution
Time to resolution of symptoms such as fever, cough or sore throat
Time frame: 7 days and again at week 4
Population: The total participants randomized in the study was 200 with an equal number in both arms (100). Of the 100 participants randomized to each arm, only 87 were able to be contacted in the intervention arm and 82 participants in the standard of care arm at Day 7. At week 4, 76 participants were able to be contacted in the intervention arm and 77 were contacted in the standard of care arm. The remaining participants were either lost to follow up or withdrew consent for participation in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Symptom Resolution | Symptoms Resolved by Day 7 | 66 Participants |
| Intervention Arm | Symptom Resolution | Symptoms resolved by Week 4 | 62 Participants |
| Standard of Care | Symptom Resolution | Symptoms Resolved by Day 7 | 52 Participants |
| Standard of Care | Symptom Resolution | Symptoms resolved by Week 4 | 61 Participants |