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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03711292
Study type Interventional
Source Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Contact
Status Completed
Phase N/A
Start date September 7, 2018
Completion date August 31, 2021

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