Clinical trial NCT03489330: Antibiotic Outbreak, Risk Factors for Never Event, Prediction of Inappropriate Use
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Midwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
name: University of Michigan
name: Henry Ford Hospital
name: Wayne State University
First posted: 2018-04-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: appropriateness of vancomycin use
timeFrame: Proposed 36 month study period
Secondary outcomes:
measure: outbreaks of never events
timeFrame: Proposed 36 month study period
Other outcomes:
Locations:
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
Study officials:
affiliation: Midwestern University
name: Marc H Scheetz, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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