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Clinical Trials/NCT03245879
NCT03245879
Completed
Not Applicable

Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Trial Intervention

Intermountain Health Care, Inc.0 sites30,000 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inappropriate Prescribing
Sponsor
Intermountain Health Care, Inc.
Enrollment
30000
Primary Endpoint
Total antibiotic use
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Core elements of effective antibiotic stewardship programs (ASPs) have been identified and evidence-based guidelines have been developed for implementation. The majority of the evidence used for these guidelines are from published studies on the effectiveness of ASPs in large academic or large community hospitals. A significant portion of healthcare in the United States, however, takes place in small hospitals. In 2015, 73% of US hospitals had < 200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days. Limited studies on the effectiveness of antibiotic stewardship implementation have been performed in hospitals with < 200 beds. Antibiotic use rates and selection patterns in these small hospitals are similar to that of large hospitals and the majority of small hospitals lack formal ASP that meet the CDC's core elements. The objective of this real-world implementation study was to assess the effectiveness of three ASP strategies of escalating intensity designed specifically for small hospitals within a vertically integrated healthcare delivery system.

Detailed Description

The investigators designed a clustered randomized controlled intervention to evaluate 3 antibiotic stewardship strategies designed for small hospitals. Each hospital was randomized to one of three ASP interventions with increasing levels of intensity and intervention (Programs 1, 2, 3). The investigators felt that clinical equipoise about the effect of ASPs did not exist and randomizing to a no-intervention group was unacceptable. Antibiotic use was compared within each group before and after the intervention. In keeping with other real-world implementation studies, secondary analyses were planned to include an interrupted time series design to evaluate the impact of each strategy. Randomization of hospitals was stratified based on patient volume. Hospital administration and clinical leadership were not blinded to which ASP program they were randomly assigned to, but there were no public announcements. The intervention started March 2014 and ended June 2015.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
June 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eddie Stenehjem

Associate Professor of Medicine

Intermountain Health Care, Inc.

Eligibility Criteria

Inclusion Criteria

  • Intermountain Healthcare acute care hospital with \< 200 licensed beds
  • No formal antibiotic stewardship program in place

Exclusion Criteria

  • All Intermountain Healthcare specialty hospitals, regardless of bed size

Outcomes

Primary Outcomes

Total antibiotic use

Time Frame: Total antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).

Evaluated change in total antibiotic use between the baseline and intervention periods while accounting for the cluster randomized design.

Secondary Outcomes

  • Broad spectrum antibiotic use(Broad spectrum antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the broad spectrum antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).)
  • 30-day readmission(30-day readmission rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day readmission rate during the 12 month baseline period (Jan 1 through Dec 31 2013).)
  • 30-day mortality(30-day mortality rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day mortality rate during the 12 month baseline period (Jan 1 through Dec 31 2013).)
  • Restricted antibiotic use(Restricted antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the restricted antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).)
  • Clostridium difficile(C. difficile rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the C. difficile rate during the 12 month baseline period (Jan 1 through Dec 31 2013).)
  • Hospital length of stay(Average hospital length of stay during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the average hospital length of stay during the 12 month baseline period (Jan 1 through Dec 31 2013).)

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