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临床试验/NCT04053075
NCT04053075已完成不适用

Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response

Harvard Pilgrim Health Care82 个研究点 分布在 1 个国家目标入组 2,905,455 人开始时间: 2019年7月23日最近更新:
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
2,905,455
试验地点
82
主要终点
Cluster Size

研究概览

简要总结

Despite the critical importance of identifying hospital-associated outbreaks as early as possible in order to limit their spread, there are currently no standardized methods for cluster detection. The CLUSTER Trial (Cluster Linkage Using Statistics to Trigger and Evaluate Response) will assess whether a statistically-based automated cluster detection method coupled with a robust response protocol will enable rapid containment of hospital clusters as measured by a reduction in cluster size and duration as compared to routine hospital cluster detection methods coupled with the same response protocol.

Note: that enrolled "subjects" represents 82 individual HCA Healthcare hospitals that have been randomized

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Facility Inclusion Criteria:
  • •All U.S. HCA Healthcare hospitals that provide inpatient care.
  • •Facilities that are reporting to the centralized data warehouse during the study period.

排除标准

  • •Note: unit of randomization is the hospital.

研究组 & 干预措施

Routine cluster detection

Active Comparator

Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.

干预措施: Routine cluster detection (Other)

Enhanced cluster detection

Active Comparator

Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.

干预措施: Enhanced cluster detection (Other)

结局指标

主要结局

Cluster Size

时间窗: 30 months

Cluster size defined as number of cases identified after the initial cluster signal through the last cluster case. NOTE: this outcome is intended for the primary manuscript.

次要结局

  • Cluster Duration(30 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Platt

Professor and Department Chair

Harvard Pilgrim Health Care

研究点 (82)

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