Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Trial Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30,000
- 主要终点
- Total antibiotic use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermountain Healthcare acute care hospital with < 200 licensed beds
- •No formal antibiotic stewardship program in place
排除标准
- •All Intermountain Healthcare specialty hospitals, regardless of bed size
研究组 & 干预措施
Program 2
This arm increases antibiotic stewardship education and interventions. Program 2 hospitals performed audit and feedback of pre-specified antibiotics and implemented locally controlled restrictions.
干预措施: Program 2 (Behavioral)
Program 1
Implementation of a basic antibiotic stewardship program focusing on education, access to Infectious Diseases physicians, and availability of antibiotic use data.
干预措施: Program 1 (Behavioral)
Program 3
This arm was the most intensive antibiotic stewardship intervention. It included signficant audit and feedback, ID controlled restrictions, and ID review of designated culture/lab results.
干预措施: Program 3 (Behavioral)
结局指标
主要结局
Total antibiotic use
时间窗: 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.
次要结局
- 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).)
研究者
Eddie Stenehjem
Associate Professor of Medicine
Intermountain Health Care, Inc.