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

March 15, 2021 updated by: Midwestern University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Downers Grove, Illinois, United States, 60515
        • Midwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The retrospective study population will be based on all inpatient intravenous vancomycin used during the proposed 36-month study period. Patient level data that identifies adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will not be collected.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Northwestern Memorial Hospital data
Inpatient intravenous vancomycin use
Henry Ford Hospital data
Inpatient intravenous vancomycin use
University of Michigan Hospital data
Inpatient intravenous vancomycin use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
appropriateness of vancomycin use
Time Frame: Proposed 36 month study period
classified as 1) never event, 2) potentially inappropriate, 3) not inappropriate
Proposed 36 month study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outbreaks of never events
Time Frame: Proposed 36 month study period
predictive interval thresholds that identify high proportion of never events
Proposed 36 month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwestern University

Collaborators

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

Investigators

  • Principal Investigator: Marc H Scheetz, PharmD, MSc, Midwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

December 29, 2020

Study Registration Dates

First Submitted

March 18, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (ACTUAL)

April 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWU3004_STU00205629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All files containing patient identifiers will be de-identified before sharing across study sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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