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临床试验/NCT02874872
NCT02874872已完成不适用

Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

University of Wisconsin, Madison0 个研究点目标入组 2,942 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,942
主要终点
Days of Antibiotic Therapy (DOT)/1000 resident days

研究概览

简要总结

The OASIS Collaborative is an organizational intervention aimed at reducing unnecessary antibiotic use in skilled nursing facilities. The first target of intervention is the tasks carried out by nursing staff after a change in condition and after an antibiotic prescription is initiated. The second target are the management staff who provide feedback to staff. The third target are the administrators who identify and overcome organizational barriers to implementation.

In this study, we will implement two tools that are intended to minimize unnecessary antibiotic use in skilled nursing facilities. The first tool helps skilled nursing facility staff assess risk and communicate with prescribers when residents experience a change in health status that may result in the use of antibiotics. The second tool is used after an antibiotic is prescribed; the tool streamlines reassessment of the patient, and provides prescribers the opportunity to consider stopping unnecessary antibiotic prescriptions, narrowing the spectrum of antibiotic therapy, or shortening the duration of antibiotic therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any nursing home resident who has received antibiotic therapy in any of the 12 participating nursing home facilities.

排除标准

  • Nursing home residents who have not received antibiotic therapy in any of the 12 participating nursing home facilities.

研究组 & 干预措施

OASIS Collaborative

Experimental

The nursing homes in this arm will receive facilitated implementation of two tools aimed at minimizing unnecessary antibiotic use. Facilitated implementation includes coaching of the nursing home staff on use of the tools. In addition, nursing home management will be coached on how to monitor implementation fidelity, antibiotic utilization, and consequences to over- and under-utilization of antibiotics as feedback on the effectiveness of the intervention. Finally, nursing home management will receive coaching on how to develop and implement a sustain plan for the OASIS intervention.

干预措施: OASIS Collaborative (Behavioral)

Control

No Intervention

The nursing homes in this arm will continue care as usual, with no tools or facilitated implementation.

结局指标

主要结局

Days of Antibiotic Therapy (DOT)/1000 resident days

时间窗: up to 12 months

Utilization of antibiotics initiated in the nursing home, defined as the number of days a nursing home resident receives antibiotic therapy. This measure includes antibiotic courses initiated 1) in the nursing home or 2) Emergency Department, if the resident returned to the nursing home without intercurrent hospitalization. This measure excludes antibiotic courses started during a hospital stay and continued in the nursing home after discharge.

Proportion of Antibiotic Starts meeting Loeb Criteria

时间窗: up to 12 months

Defined as the proportion of antibiotic courses started in the nursing home or Emergency department that satisfy the Loeb minimum criteria for initiation of antibiotics. This measure includes antibiotic courses initiated 1) in the nursing home or 2) Emergency Department, if the resident returned to the nursing home without intercurrent hospitalization. This measure excludes antibiotic courses started during a hospital stay and continued in the nursing home after discharge.

次要结局

  • Fluoroquinolone Days of Therapy (FQD)/1000 resident days(up to 12 months pre-implementation and up to 12 months post-implementation)
  • Incidence of C.diff infection/1000 resident days(up to 12 months pre-implementation and up to 12 months post-implementation)
  • Fluoroquinolone resistance(up to 12 months pre-implementation and up to 12 months post-implementation)
  • Positive Enterococcus species(up to 12 months pre-implementation and up to 12 months post-implementation)
  • Positive Candida species(up to 12 months pre-implementation and up to 12 months post-implementation)
  • Incidence of antibiotic starts/1000 resident days(up to 12 months pre-implementation and up to 12 months post-implementation)

研究者

申办方类型
Other
责任方
Sponsor

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