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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Standard of care | No Intervention | The second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During ED stay, up to 48 hours |
| 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. | During ED stay, up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department Recidivism | Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV | 30 days |
| Symptom Resolution | Time to resolution of symptoms such as fever, cough or sore throat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larissa S May, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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During the enrollment period, 1259 ED patients were assessed for inclusion and 200 were randomized into the research study.
Participants were recruited after presentation to the Emergency Department between March 2018 and April 2022 at the University of California Davis Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization to 7 Day Follow Up Contact |
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| Day 7 to 4 Week Follow Up Contact |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | During ED stay, up to 48 hours |
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From time of assignment until study completion (at week 4).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larissa May, MD, MSHS, MSPH, Director of Emergency Medicine Innovation and External Partnerships | UC Davis Medical Center | 916-734-1593 | lsmay@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Jun 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Pharmacist-Led Education | Other | 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. |
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| 7 days and again at week 4 |
| Lost Days of School/Work | Number of days of school and/or work missed due to illness | 7 days and again at week 4 |
| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education - n = Some college | Count of Participants | Participants |
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| Height | Not all patients who present to the ED have their height measured; therefore, a portion of the study population do not have a recorded height. | Mean | Standard Deviation | inches |
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| Weight | Not all patients who present to the ED are weighed; therefore, a small portion of the study population do not have a recorded weight. | Mean | Standard Deviation | kilograms |
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| Temperature | One participant did not have a recorded temperature. | Mean | Standard Deviation | celsius |
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| Influenza A positive | Count of Participants | Participants |
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| Influenza B positive | Count of Participants | Participants |
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| Respiratory syncytial virus - RSV positive | Count of Participants | Participants |
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| OG001 | 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. |
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| 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. | Posted | Count of Participants | Participants | During ED stay, up to 48 hours |
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| Secondary | Emergency Department Recidivism | Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV | Number of participants who tested positive during their initial ED visit | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Symptom Resolution | Time to resolution of symptoms such as fever, cough or sore throat | 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. | Posted | Count of Participants | Participants | 7 days and again at week 4 |
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| Secondary | Lost Days of School/Work | Number of days of school and/or work missed due to illness | 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. | Posted | Mean | Standard Deviation | Days | 7 days and again at week 4 |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | 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. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Symptoms resolved by Week 4 |
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| Work days missed at day 7 |
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| School days missed at week 4 |
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| Work days missed at week 4 |
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