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Clinical Trials/NCT03489330
NCT03489330
Completed
Not Applicable

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

Midwestern University1 site in 1 country2,000 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infectious Disease
Sponsor
Midwestern University
Enrollment
2000
Locations
1
Primary Endpoint
appropriateness of vancomycin use
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 29, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

appropriateness of vancomycin use

Time Frame: Proposed 36 month study period

classified as 1) never event, 2) potentially inappropriate, 3) not inappropriate

Secondary Outcomes

  • outbreaks of never events(Proposed 36 month study period)

Study Sites (1)

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