Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings

NCT ID: NCT03711292

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2021-08-31

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.

Conditions

Antimicrobial Stewardship; Acute Bronchitis; Upper Respiratory Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Stepped Wedge Cluster Randomized

Antibiotic stewardship intervention

Group Type: EXPERIMENTAL

Antibiotic Stewardship

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Prescribing provider in an adult emergency department or urgent care center in the Los Angeles County Department of Health Services.

• 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

• Provider has not treated a patient with an ARI

Eligibility (patient)

• None

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Los Angeles County Department of Public Health

OTHER_GOV

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kabir Yadav, MDCM MS MSHS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Department of Health Services

Los Angeles, California, United States

Countries

United States

Other Identifiers

UL1TR001881

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31429-01

Identifier Type: -

Identifier Source: org_study_id