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OpenTrials
Completed

NCT Number: NCT03489330

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwestern University

Downers Grove, Illinois, 60515, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. appropriateness of vancomycin use

    Time frame: Proposed 36 month study period

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

Secondary outcomes

  1. outbreaks of never events

    Time frame: Proposed 36 month study period

    predictive interval thresholds that identify high proportion of never events

Sponsors and collaborators

Lead sponsor

Midwestern University

Other

Collaborators

  • Henry Ford Hospital
  • Northwestern Memorial Hospital
  • University of Michigan
  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Apr 5, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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