Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
Primary Purpose
Antimicrobial Stewardship, Acute Bronchitis, Upper Respiratory Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antibiotic Stewardship
Sponsored by
About this trial
This is an interventional health services research trial for Antimicrobial Stewardship focused on measuring Emergency Department, Urgent Care Center, Behavioral Sciences
Eligibility Criteria
The primary research subjects involved in this trial are prescribing providers who will be recruited from multiple clinical sites in Los Angeles County Department of Health Services.
Eligibility (provider)
Inclusion Criteria:
* Prescribing provider in an adult emergency department or urgent care center in the Los Angeles County Department of Health Services.
Exclusion Criteria:
* Provider has not treated a patient with an ARI
Eligibility (patient)
Inclusion Criteria:
- Treated at a Los Angeles County Department of Health Services facility with an ARI diagnosis
- Cared for by a provider and in practice site enrolled in the study
- Visit occurred during the 12-month intervention period, or the 12-month historical baseline period
- Did not have a visit with any ARI diagnosis in the prior 30 days
Exclusion Criteria:
* None
Sites / Locations
- Department of Health Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stepped Wedge Cluster Randomized
Arm Description
Antibiotic stewardship intervention
Outcomes
Primary Outcome Measures
Antibiotic prescribing
The primary outcome measure is the rate of antibiotic prescribing for non-antibiotic-appropriate acute respiratory infections or in other words, acute respiratory infections that are presumed to be viral in nature. The International Classification of Diseases (ICD)-10 codes for primary outcomes are defined in detail in the clinical trials protocol document. These outcomes are computable clinical quality measures from the electronic health record. These are widely used in medicine to evaluate quality improvement and reliability and validity are generally supported.
Visits are excluded from the primary analysis when: 1) patients have certain medical co-morbidities that make ARI guidelines less likely to apply, 2) patients had concomitant visit diagnoses indicating a non-ARI possible bacterial infection, or 3) patients had concomitant visit diagnoses indicating potentially antibiotic appropriate ARI diagnoses or other ARI diagnoses suggestive of a bacterial infection.
Secondary Outcome Measures
Diagnostic drift
Throughout the course of the study, the investigators will also be monitoring "diagnostic drift" that may result in provider shifting diagnosis to avoid guideline conflicts that might trigger poor performance reports. An auditing program will measure diagnostic deviation from each clinician's historical rates of diagnosing acute respiratory infections.
Full Information
NCT ID
NCT03711292
First Posted
October 16, 2018
Last Updated
January 19, 2023
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Los Angeles County Department of Public Health, University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03711292
Brief Title
Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
Official Title
Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Los Angeles County Department of Public Health, University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stepped wedge behavioral intervention clinical trial looking at the impact of an antibiotic stewardship intervention on provider prescribing behavior for acute respiratory infections (ARIs), where the intervention is administered at the emergency department or urgent care center site level, using a cluster randomization process. Thus, every site and every provider are eligible to be exposed to the stewardship intervention, the cluster randomized stepped wedge process simply randomizes when they will be exposed. The overall study hypothesis is that providers will prescribe fewer unnecessary antibiotics to patients with ARIs after the intervention.
Detailed Description
Hypothesis: The primary hypothesis is that acute care ambulatory settings randomized to receive behavioral economic stewardship interventions will have decreased antibiotic prescribing rates for non-antibiotic appropriate ARIs, compared to contemporaneous antibiotic prescribing rates for non-antibiotic appropriate ARIs among control practices. This hypothesis will be evaluated in a linear mixed effects model will be used to estimate and test the group effect using group and time as fixed effects and practice site and provider as random effects. The interaction between time and group will be included to estimate and test the different group effect over time.
Design: The investigators will conduct a stepped wedge cluster randomized trial of acute care ambulatory visits to emergency departments and urgent care centers in a predominantly non-academic public hospital system. Clustering (by site) helps prevent treatment contamination between individual clinicians within the same site. The stepped wedge design will allow studying the effects of a complex intervention rolled out through a system over time, as often happens in the real-world, where State and Federal public health as well as site-based organization quality improvement interventions may be occurring at different times.
Treatment Assignment Procedures: For the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with Centers for Disease Control and Prevention (CDC) core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antimicrobial Stewardship, Acute Bronchitis, Upper Respiratory Infection
Keywords
Emergency Department, Urgent Care Center, Behavioral Sciences
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Stepped wedge cluster randomized trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stepped Wedge Cluster Randomized
Arm Type
Experimental
Arm Description
Antibiotic stewardship intervention
Intervention Type
Behavioral
Intervention Name(s)
Antibiotic Stewardship
Intervention Description
For the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with CDC core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs.
Primary Outcome Measure Information:
Title
Antibiotic prescribing
Description
The primary outcome measure is the rate of antibiotic prescribing for non-antibiotic-appropriate acute respiratory infections or in other words, acute respiratory infections that are presumed to be viral in nature. The International Classification of Diseases (ICD)-10 codes for primary outcomes are defined in detail in the clinical trials protocol document. These outcomes are computable clinical quality measures from the electronic health record. These are widely used in medicine to evaluate quality improvement and reliability and validity are generally supported.
Visits are excluded from the primary analysis when: 1) patients have certain medical co-morbidities that make ARI guidelines less likely to apply, 2) patients had concomitant visit diagnoses indicating a non-ARI possible bacterial infection, or 3) patients had concomitant visit diagnoses indicating potentially antibiotic appropriate ARI diagnoses or other ARI diagnoses suggestive of a bacterial infection.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diagnostic drift
Description
Throughout the course of the study, the investigators will also be monitoring "diagnostic drift" that may result in provider shifting diagnosis to avoid guideline conflicts that might trigger poor performance reports. An auditing program will measure diagnostic deviation from each clinician's historical rates of diagnosing acute respiratory infections.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The primary research subjects involved in this trial are prescribing providers who will be recruited from multiple clinical sites in Los Angeles County Department of Health Services.
Eligibility (provider)
Inclusion Criteria:
* Prescribing provider in an adult emergency department or urgent care center in the Los Angeles County Department of Health Services.
Exclusion Criteria:
* Provider has not treated a patient with an ARI
Eligibility (patient)
Inclusion Criteria:
Treated at a Los Angeles County Department of Health Services facility with an ARI diagnosis
Cared for by a provider and in practice site enrolled in the study
Visit occurred during the 12-month intervention period, or the 12-month historical baseline period
Did not have a visit with any ARI diagnosis in the prior 30 days
Exclusion Criteria:
* None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kabir Yadav, MDCM MS MSHS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
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