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

NCT03711292 | Completed

• 2 other identifiers: 31429-01UL1TR001881
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Antimicrobial Stewardship; Acute Bronchitis; Upper Respiratory Infection

Keywords

Emergency Department; Urgent Care Center; Behavioral Sciences

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Diagnostic drift

  12 months

Study Arms (1)

Stepped Wedge Cluster Randomized

EXPERIMENTAL

Antibiotic stewardship intervention

Behavioral: Antibiotic Stewardship

Interventions

Antibiotic Stewardship 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.

Stepped Wedge Cluster Randomized

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \* Provider has not treated a patient with an ARI
• Eligibility (patient)
• 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
• \* None

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Los Angeles County Department of Public Health: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Department of Health Services

Los Angeles, California, 90012, United States

Location

MeSH Terms

Conditions

Bronchitis; Respiratory Tract Infections; Emergencies

Interventions

Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Utilization Review; Drug Utilization; Pharmacy Administration; Organization and Administration; Health Services Administration; Utilization Review; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Kabir Yadav, MDCM MS MSHS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: September 7, 2018
• Primary Completion: February 28, 2021
• Study Completion: August 31, 2021
• Last Updated: January 23, 2023

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)