Understanding and Addressing Variation in Healthcare-Associated Infections After Durable Ventricular Assist Device Therapy

项目总结/摘要 耐用的心室辅助装置（VAD）提供长期的机械循环支持，作为 心脏移植或作为永久性治疗，并有可能使超过25万例患者受益， 指南指导的药物治疗难治性晚期心力衰竭（HF）。每10个人中就有6个 VAD患者在植入后发生医疗保健相关感染（HAI）。更广泛地采用耐用 由于HAI与死亡率相关（1年死亡风险增加5.6倍），HAI阻碍了VAD治疗。 死亡率）和医疗保健支出（每位患者26.4万至86.9万美元）。 大多数在VAD治疗背景下评价HAI的研究仅限于对小样本的事后分析。 试验或单中心试验。虽然有些人认为HAI率较低的中心选择更健康的 病人，其他人反驳说，改善的做法（例如，标准化经验性和靶向抗菌剂 治疗）或增强的提供者团队合作更能预测改善的结果。虽然基于证据 HAI预防指南和实施工具（例如，检查表）存在，这些方法不 全面的（例如，忽略设备特定的决定因素）或可定制到本地环境，从而限制了 可用性、采用率和预防HAI的显著有效性的可能性。了解障碍 和促进者在个别中心，以最大限度地采取预防措施将作为 有针对性的战略基础。如果不了解这些情况， 在预防VAD植入后HAI方面的本地采用和最终有效性有限。 我们的长期目标是发展并随后促进循证HAI的广泛采用 永久性VAD植入后的预防措施。本提案的目的是确定预防 VAD植入后最显著HAI的建议。为达致这个目标，我们会 对2009 - 2017年在美国接受VAD的成人患者进行混合方法研究，并制定一项 基于证据的建议模块化工具包。为了确定预防HAI的最佳做法，我们将 检查HAI率的中心水平差异，以确定低HAI率中心使用的策略和障碍 降低高比率中心的HAI比率。我们将使用一个新的数据集，包括行政 索赔和详细的临床数据，沿着深入的中心调查，以解决以下目标：（i）识别 中心一级HAI率变化的决定因素，（ii）全面了解障碍， 促进实现低中心HAI率，以及（iii）开发，迭代增强和传播最佳 用于防止HAI的实践工具包，可适应各种中心环境。 我们的研究将通过确定干预性研究的目标对临床实践产生积极影响。 此外，我们的混合方法方法将作为评估和改善临床护理的模式， 广泛地-特别是在复杂的外科手术中。

Project Summary/Abstract 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. Our 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, we 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, we 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. We 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. Our studies will have a positive impact on clinical practice by identifying targets for an interventional study. Moreover, our mixed methods approach will serve as a model for evaluating and improving clinical care more broadly – especially in the setting of complex surgical procedures.