Clincosm LogoSign in Get a demo

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

Sponsor
Midwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT03489330
Collaborator
Northwestern Memorial Hospital (Other), University of Michigan (Other), Henry Ford Hospital (Other), Wayne State University (Other)
2,000
Enrollment
1
Location
83.9
Actual Duration (Months)
23.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official 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
    Actual Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Oct 1, 2017
    Actual Study Completion Date :
    Dec 29, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. appropriateness of vancomycin use [Proposed 36 month study period]

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

    Secondary Outcome Measures

    1. outbreaks of never events [Proposed 36 month study period]

      predictive interval thresholds that identify high proportion of never events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Midwestern University Downers Grove Illinois United States 60515

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Midwestern University
    ClinicalTrials.gov Identifier:
    NCT03489330
    Other Study ID Numbers:
    • MWU3004_STU00205629
    First Posted:
    Apr 5, 2018
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Midwestern University
    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
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections

    Study Results

    No Results Posted as of Mar 16, 2021