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Antibiotic Outbreak, Risk Factors for Never Event, Prediction of Inappropriate Use

A Retrospective Study to Understand the Risk Factors/Drivers of Inappropriate Antimicrobial Use and the Performance Evaluation of a Clinical Decision Support Tool That Facilitates Prediction of Outbreaks of Inappropriate Antibiotic Use

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03489330
Enrollment
2000
Registered
2018-04-05
Start date
2014-01-01
Completion date
2020-12-29
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

Keywords

Anti-Bacterial Agents/therapeutic use, Drug Utilization/statistics & numerical data, Hospitals/statistics & numerical data, Data Analysis, Statistical, Interpretation, Statistical Data, Antibiotic Stewardship, Electronic Medical Record

Brief summary

In order to decrease inappropriate antibiotic use, drivers of inappropriate use must be identified locally. This study will focus on the MOST inappropriate use, which are defined as 'never events'. Previous work has shown that antibiotic use clusters over time. It is hypothesized that never events also cluster over time. Using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. Secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

Detailed description

Appropriateness in antimicrobial prescribing has become a focal national and international issue. It has been estimated that upwards of 50% of antibiotic use is inappropriate. With this backdrop, a national strategic goal has been set by the United States White House to decrease inappropriate antibiotic use by 20% and 50%, respectively for inpatient and outpatient settings. In order to decrease inappropriate use, drivers of incorrect use must be identified at each local setting. The actual drivers of confirmed inappropriate use have been difficult to identify except when using time and resource intense chart reviews. Even the largest contemporary antibiotic consumption studies have not assessed appropriateness as it was 'outside of study scope'. Further, there is no consensus or agreement on what constitutes inappropriate use. These apparent omissions underscore the difficulty and complexity in attributing appropriateness of use for antimicrobials. Importantly, this study will focus on the MOST inappropriate use, which are defined as 'never events'. Previous work has shown that antibiotic use clusters over time. It is hypothesized that never events also cluster over time. Using electronic data capture strategies, an algorithm will be developed to quickly and accurately identify areas of antibiotic use concern. Secondly, a framework will be developed, utilizing antimicrobial consumption data and captured signals of inappropriate antimicrobial use to provide targets for antimicrobial stewardship efforts.

Interventions

None listed

Sponsors

Northwestern Memorial Hospital
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
Henry Ford Hospital
CollaboratorOTHER
Wayne State University
CollaboratorOTHER
Midwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* receipt of inpatient intravenous vancomycin during proposed study period * adults 18 years of age or older and less than 90 years of age

Exclusion criteria

* individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Design outcomes

Primary

MeasureTime frameDescription
appropriateness of vancomycin useProposed 36 month study periodclassified as 1) never event, 2) potentially inappropriate, 3) not inappropriate

Secondary

MeasureTime frameDescription
outbreaks of never eventsProposed 36 month study periodpredictive interval thresholds that identify high proportion of never events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026