Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
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|ClinicalTrials.gov Identifier: NCT03711292|
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Antimicrobial Stewardship Acute Bronchitis Upper Respiratory Infection||Behavioral: Antibiotic Stewardship||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Stepped wedge cluster randomized trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings|
|Actual Study Start Date :||September 7, 2018|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||October 31, 2020|
Experimental: Stepped Wedge Cluster Randomized
Antibiotic stewardship intervention
Behavioral: Antibiotic Stewardship
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.
- Antibiotic prescribing [ Time Frame: 12 months ]
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.
- Diagnostic drift [ Time Frame: 12 months ]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.
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): NCT03711292
|Contact: Kabir Yadav, MDCM MS MSHSfirstname.lastname@example.org|
|United States, California|
|Department of Health Services||Recruiting|
|Los Angeles, California, United States, 90012|
|Contact: Kabir Yadav, MDCM MS MSHS 424-306-5400 email@example.com|
|Principal Investigator:||Kabir Yadav, MDCM MS MSHS||University of California, Los Angeles|