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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711292
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : July 2, 2019
Sponsor:
Collaborators:
Los Angeles County Department of Public Health
University of California, Los Angeles
Information provided by (Responsible Party):
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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.

Condition or disease Intervention/treatment Phase
Antimicrobial Stewardship Acute Bronchitis Upper Respiratory Infection Behavioral: Antibiotic Stewardship Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Contacts
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Contact: Kabir Yadav, MDCM MS MSHS 3102223503 kabir@emedharbor.edu

Locations
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United States, California
Department of Health Services Recruiting
Los Angeles, California, United States, 90012
Contact: Kabir Yadav, MDCM MS MSHS    424-306-5400    kyadav@dhs.lacounty.gov   
Sponsors and Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Los Angeles County Department of Public Health
University of California, Los Angeles
Investigators
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Principal Investigator: Kabir Yadav, MDCM MS MSHS University of California, Los Angeles

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Responsible Party: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT03711292    
Other Study ID Numbers: 31429-01
UL1TR001881 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
Emergency Department
Urgent Care Center
Behavioral Sciences
Additional relevant MeSH terms:
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Respiratory Tract Infections
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents