Antibiotic Stewardship in Small Hospitals (SCORE)
2017年8月7日 更新者：Eddie Stenehjem、Intermountain Health Care, Inc.
Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Trial Intervention
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
30000
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Program 1
Implementation of a basic antibiotic stewardship program focusing on education, access to Infectious Diseases physicians, and availability of antibiotic use data.
|
Program 1 hospitals received a basic curriculum and tools for implementation of basic antibiotic stewardship interventions.
Hospitals required an indication for every antibiotic order.
A daily email was sent to a designated email account when a patient had been on an antibiotic for >48 hours.
Curriculum included implementing antibiotic time-outs, IV to PO conversion, indications, evaluating for bug-drug mismatches, and recommendations on when to call the Infectious Diseases (ID) hotline.
A daily antibiotic stewardship check list was created.
All materials were provided to all pharmacists and remained on-site.
Clinicians had access to an ID telephone hotline to answer clinical questions.
Pharmacy directors and hospital leadership were provided a monthly, hospital-specific, antibiotic use dashboard.
All pharmacy directors and staff received a monthly newsletter.
|
|
有源比较器：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.
|
Program 2 hospitals received all the interventions of Program 1.
In addition, Program 2 hospitals received more intense antibiotic stewardship education.
Educational topics included audit and feedback, antibiotic de-escalation, the need for antibiotics targeting anaerobic bacteria, antibiotic allergy verification, and antibiotic restrictions.
Pharmacists in Program 2 hospitals reviewed patients on vancomycin, piperacillin/tazobactam, imipenem, meropenem, and cefepime.
For patients receiving one of these antibiotics, pharmacists reviewed the patients' microbiology data to identify opportunities for antibiotic de-escalation, IV to PO conversion, bug-drug mismatches, and/or indications for calling the ID hotline.
Program 2 hospitals also restricted daptomycin, linezolid, imipenem, meropenem, ceftaroline, tigecycline, and all mold active antifungals.
In Program 2 hospitals, the local pharmacy staff pre-authorized restricted antibiotics based on defined criteria.
|
|
有源比较器：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.
|
Program 3 hospitals received all the interventions of Program 1 and Program 2. In addition, pharmacists in program 3 hospitals reviewed an expanded list of antibiotics for audit and feedback.
These antibiotics included: Vancomycin, piperacillin/tazobactam, imipenem, meropenem, cefepime, ertapenem, aminoglycosides, ceftriaxone, and fluoroquinolones.
Program 3 hospitals implemented the same antibiotic restrictions as Program 2 but ID pharmacists controlled pre-authorization of restricted antibiotics.
In addition, an ID physician reviewed pre-specified positive cultures (e.g.
all positive blood cultures, cultures with highly resistant Enterobacteraciae) and contacted providers with recommendations as needed.
ID physician review occurred Monday through Friday and alerts were batched daily at 6am.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total antibiotic use
大体时间：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.
|
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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Broad spectrum antibiotic use
大体时间：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).
|
Evaluated change in broad spectrum antibiotic use between the baseline and intervention periods
|
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).
|
|
Restricted antibiotic use
大体时间：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).
|
Evaluated change in restricted antibiotic use between the baseline and intervention periods
|
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).
|
|
30-day readmission
大体时间：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).
|
Evaluated change in 30 day readmission rates between the baseline and intervention periods
|
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
大体时间：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).
|
Evaluated change in 30 day mortality rates between the baseline and intervention periods
|
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).
|
|
Hospital length of stay
大体时间：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).
|
Evaluated change in hospital length of stay between the baseline and intervention periods
|
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).
|
|
Clostridium difficile
大体时间：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).
|
Evaluated change in Clostridium difficile incidence between the baseline and intervention periods
|
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).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Stenehjem E, Hersh AL, Sheng X, Jones P, Buckel WR, Lloyd JF, Howe S, Evans RS, Greene T, Pavia AT. Antibiotic Use in Small Community Hospitals. Clin Infect Dis. 2016 Nov 15;63(10):1273-1280. doi: 10.1093/cid/ciw588. Epub 2016 Sep 30.
- Stenehjem E, Hersh AL, Buckel WR, Jones P, Sheng X, Evans RS, Burke JP, Lopansri BK, Srivastava R, Greene T, Pavia AT. Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Intervention. Clin Infect Dis. 2018 Aug 1;67(4):525-532. doi: 10.1093/cid/ciy155.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年7月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2017年8月3日
首先提交符合 QC 标准的
2017年8月7日
首次发布 (实际的)
2017年8月10日
研究记录更新
最后更新发布 (实际的)
2017年8月10日
上次提交的符合 QC 标准的更新
2017年8月7日
最后验证
2017年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 1024823
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
N/A.
No individual patient level data available.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Program 1的临床试验
-
University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
-
The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中
-
Ghana Health ServicesKwame Nkrumah University of Science and Technology尚未招聘戒烟 | 减少吸烟 | 吸烟，烟草 | 吸烟行为
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险
-
University of AlbertaUniversity of British Columbia; Provincial Health Services Authority; Glenrose Foundation; Neuro... 和其他合作者完全的