Clinical trial NCT03711292: 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
Overall status: COMPLETED
Phase: NA
Conditions: Antimicrobial Stewardship
Acute Bronchitis
Upper Respiratory Infection
Keywords: Emergency Department
Urgent Care Center
Behavioral Sciences
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
name: University of California, Los Angeles
First posted: 2018-10-18
Enrollment: 134
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Antibiotic prescribing
timeFrame: 12 months
Secondary outcomes:
measure: Diagnostic drift
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Department of Health Services
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kabir Yadav, MDCM MS MSHS
role: PRINCIPAL_INVESTIGATOR
References: