Fluoroquinolone Restriction for the Prevention of C. difficile Infection (CDI)_the FIRST Trial.

氟喹诺酮类药物限制用于预防艰难梭菌感染 (CDI)_FIRST 试验。

• 批准号: 9753142
• 负责人: NASIA SAFDAR
• 金额: $ 49.04万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753142
• 关键词: Fluoroquinolone; Restriction; Prevention; C.; difficile

Abstract Each year, Clostridium difficile infection (CDI) affects 453,000 Americans, causes 29,000 deaths, and leads to an estimated $4.8 billion in excess costs in acute care hospitals within the US. Effective infection control measures and antibiotic stewardship (AS) are fundamental to sustained control of CDI in healthcare settings. There is an urgent need to identify and implement AS strategies that specifically target CDI by focusing on reducing use of antibiotics highly associated with increased risk of CDI, such as fluoroquinolones (FQ). Preprescription authorization (PPA) and postprescription review with feedback are two core AS strategies. However, it is unclear 1) which AS strategies are most effective in reducing CDI specifically and 2) how to implement AS strategies effectively. Without addressing these critical gaps, CDI prevention will continue to lag. The objective of the proposed study is to evaluate the effectiveness and implementation of a FQ PPA as an AS strategy to target and prevent CDI, promote appropriate antibiotic use, and reduce the transmission of resistant bacteria. This will contribute to the long-term goal of reducing the burden of CDI, which is an essential step in improving the safety and quality of healthcare. FQ PPA is a particularly promising AS strategy to reduce CDI. Although FQs are one of the most frequently utilized classes of antibiotics in inpatient acute care facilities and are closely associated with risk for CDI, FQ usage has not been the focus of control efforts in endemic settings in the US. The proposed study will use an effectiveness-implementation hybrid type 2 design to simultaneously evaluate the efficacy of an FQ PPA intervention to reduce CDI as well as the key considerations for implementing such an intervention successfully. Intensive care units in acute care hospitals throughout Wisconsin will participate in this stepped wedge cluster randomized controlled trial. The specific aims for the proposed study are to: 1) determine the impact of a FQ PPA on hospital-onset and healthcare-associated CDI rates and other clinical outcomes compared with usual care; and 2) evaluate the implementation of FQ PPA using a systems engineering approach. For aim 1, electronic health record data will be used to evaluate the impact of the FQ PPA on hospital-onset and healthcare-associated CDI, as well as other important clinical outcomes. For aim 2, surveys and interviews with healthcare providers will be used to evaluate the contextual, implementation, and work system factors that contribute to successful implementation of a FQ PPA intervention. In addition to addressing an urgent need to identify effective AS strategies, this study will provide a framework to implement and evaluate other interventions for HAI prevention. Regardless of the results, the proposed study will generate data, tools and methods with widespread applicability for AS initiatives in healthcare-associated infection prevention.

抽象的 每年，艰难梭菌感染（CDI）会影响453,000名美国人，导致29,000人死亡，并导致 估计在美国急诊医院的急诊医院的超额费用估计为48亿美元。有效的感染控制 措施和抗生素管理（AS）是医疗环境中CDI持续控制的基础。 迫切需要识别和实施作为专门针对CDI的策略 减少与CDI风险增加的抗生素的使用，例如氟喹诺酮类（FQ）。 用反馈的预分量授权（PPA）和预定后审查是两个核心作为策略。 但是，目前尚不清楚1）哪些策略在减少CDI方面最有效，以及2）如何 有效地实施策略。在没有解决这些关键差距的情况下，CDI预防将继续落后。 拟议研究的目的是评估FQ PPA的有效性和实施 靶向和预防CDI，促进适当的抗生素使用并减少抗性的传播的策略 细菌。这将有助于减轻CDI负担的长期目标，这是重要的一步 提高医疗保健的安全性和质量。 FQ PPA是减少CDI的策略特别有希望的。 尽管FQ是住院急性护理设施中最常使用的抗生素类别之一 与CDI的风险密切相关，FQ使用并不是地方性环境中控制努力的重点 在美国。拟议的研究将同时使用有效性的杂种2型设计来同时 评估FQ PPA干预以减少CDI的功效以及关键考虑因素 成功实施这种干预措施。整个急诊医院的重症监护病房 威斯康星州将参加此阶梯楔形群集随机对照试验。具体目标 拟议的研究是：1）确定FQ PPA对医院发作和医疗保健相关的CDI的影响 与通常的护理相比，比率和其他临床结果； 2）评估FQ PPA的实施 使用系统工程方法。对于AIM 1，电子健康记录数据将用于评估 FQ PPA对医院发作和医疗保健相关的CDI以及其他重要临床的影响 结果。对于AIM 2，将使用调查和对医疗保健提供者的访谈来评估上下文， 实施以及有助于成功实施FQ PPA的工作系统因素 干涉。除了解决迫切需要确定有效为策略的需求之外，本研究还将提供 实施和评估预防HAI的其他干预措施的框架。无论结果如何 拟议的研究将生成具有广泛适用性的数据，工具和方法 医疗保健相关的感染预防。