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临床试验/NCT03749434
NCT03749434已完成不适用

Understanding and Addressing Variations in Healthcare-associated Infections (HAIs) After Durable Ventricular Assist Device Therapy

University of Michigan1 个研究点 分布在 1 个国家目标入组 34,958 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34,958
试验地点
1
主要终点
Number of patients who have developed a healthcare-associated infection within 90 days following a ventricular assist device (VAD) implant

研究概览

简要总结

Substantial center variability exists in healthcare-associated infection (HAI) rates following durable ventricular assist device (VAD) implantation for patients with advanced heart failure. Preliminary evidence suggests that this variability may be related to process (e.g., pre-operative intranasal mupirocin), provider (e.g., surgeon technique, physician teamwork), device, (e.g., centrifugal vs. axial flow), and center specific (e.g., infection prevention strategies and resources) factors. The investigators will undertake a mixed methods study to: (1) identify determinants of center-level variability in HAI rates, (2) develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates, and (3) develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

详细描述

Durable ventricular assist devices (VADs) provide long-term mechanical circulatory support as a bridge to cardiac transplantation or as permanent therapy, and have the potential to benefit more than 250K patients with advanced heart failure (HF) refractory to guideline-directed medical therapy. Upwards of six out of every 10 VAD patients develop a healthcare-associated infection (HAI) following implant. Broader adoption of durable VAD therapy is hindered by HAIs given their association with mortality (5.6-fold increased risk of 1-year mortality) and healthcare expenditures ($264K - $869K per patient).

Most studies evaluating HAIs in the setting of VAD therapy have been limited to post-hoc analyses of small trials, or single center experiences. While some argue that centers with lower HAI rates select healthier patients, others counter that improved practices (e.g., standardizing empirical and targeted antimicrobial therapy) or enhanced provider teamwork are more predictive of improved outcomes. While evidence-based HAI prevention guidelines and implementation tools (e.g., checklists) exist, these approaches are not comprehensive (e.g., neglecting device-specific determinants) or customizable to local context, thus limiting usability, adoption, and likelihood of significant effectiveness for preventing HAIs. Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation. The investigators' long-term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation. The objective of this proposal is to identify prevention recommendations for the most significant HAIs after VAD implantation. To achieve this objective, the investigators will undertake a mixed methods study of adult patients receiving VADs in the U.S. from 2009 - 2017 and develop a modular toolkit of evidence-based recommendations. To determine best practices for preventing HAIs, the investigators will examine center-level differences in HAI rates to identify strategies used by centers with low rates, and barriers to lowering HAI rates among centers with high rates. The investigators will use a novel dataset including administrative claims and detailed clinical data, along with in-depth center surveys, to address the following aims: (i) identify determinants of center-level variability in HAI rates, (ii) develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates, and (iii) develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

These studies will have a positive impact on clinical practice by identifying targets for an interventional study. Moreover, the mixed methods approach will serve as a model for evaluating and improving clinical care more broadly - especially in the setting of complex surgical procedures.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Female and Male adult patients 18 and over who have received a FDA-approved, durable ventricular assist device implant from 2008 onwards

排除标准

  • 未提供

结局指标

主要结局

Number of patients who have developed a healthcare-associated infection within 90 days following a ventricular assist device (VAD) implant

时间窗: 90 days following a VAD implant

Any healthcare-associated infection within 90 days following a VAD implant

次要结局

  • Type of healthcare-associated infection(90 days following a VAD implant)

研究者

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

Dr. Donald Likosky

Richard and Norma Sarns Research Professor of Cardiac Surgery

University of Michigan

研究点 (1)

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