跳至主要内容
临床试验/NCT04815369
NCT04815369撤回不适用

Evaluating UTI Diagnosis in Nursing Homes

Pathnostics1 个研究点 分布在 1 个国家目标入组 40,000 人开始时间: 2021年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Pathnostics
入组人数
40,000
试验地点
1
主要终点
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events.

研究概览

简要总结

This prospective, multicenter, comparative cohort observational study is to determine whether the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of UTI patients with poor outcomes.

详细描述

The objective of this study is to determine if prospective data, collected over 12 months from over 200 nursing homes, will show that the use of Guidance® UTI Clinical Pathway is more effective than the Traditional Clinical Pathways for urine testing in UTI diagnosis in Nursing Homes. Guidance® UTI Clinical Pathway provides standardized infrastructure for specimen collection, and result dissemination via assigned report point person to verify receipt of actionable data. The pathway also includes several in-services on molecular testing for UTI, Pooled Antibiotic Susceptibility Testing, and polymicrobial infections to help providers better understand test methodology. Standardizing a Clinical Care Pathway for testing and reporting of clinical results approach may lead to a reduction in empiric broad spectrum antibiotic use and in turn better health-related outcomes for patients. Such efficiency in clinical decision making at the time of initial presentation may lead to improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab diagnosis. The study will be observing the implementation of the Guidance® UTI Clinical Pathway and comparing it to traditional clinical care pathways from facility-level data entered into the National Healthcare Safety Network for its LTCF (Long Term Care Facilities) Component.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events.

时间窗: 12 Months

Examine the proportion of patients with UTI-related adverse events requiring emergency hospital services over the course the study with a composite measure of the number of UTI related ED visits and/or subsequent hospitalizations and/or sepsis events.

次要结局

  • Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use.(30 Days)
  • Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management .(12 Months)
  • Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.(30 Days)

研究者

发起方
Pathnostics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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