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

摘要 每年，艰难梭菌感染（CDI）影响453，000名美国人，导致29，000人死亡，并导致 估计美国急症护理医院的额外费用为48亿美元。有效的感染控制 措施和抗生素管理（AS）是在医疗保健环境中持续控制CDI的基础。 迫切需要确定和实施具体针对CDI的AS战略， 减少使用与CDI风险增加高度相关的抗生素，如氟喹诺酮类（FQ）。 处方前授权（PPA）和处方后审查与反馈是两个核心的AS策略。 然而，目前尚不清楚1）哪些AS策略在降低CDI方面最有效，2）如何 有效实施AS战略。如果不解决这些关键的差距，预防儿童疾病感染的工作将继续滞后。 拟议研究的目的是评估FQ PPA作为AS的有效性和实施情况 针对和预防CDI的战略，促进适当的抗生素使用，并减少耐药菌的传播 细菌这将有助于实现减轻土发委会负担的长期目标， 提高医疗保健的安全性和质量。FQ PPA是一个特别有前途的AS策略，以减少CDI。 尽管FQs是住院急症护理设施中最常用的抗生素类别之一， 与CDI的风险密切相关，FQ的使用尚未成为流行病环境中控制工作的重点 在美国.拟议的研究将使用有效性-实施混合2型设计， 评估FQ PPA干预降低CDI的有效性以及以下关键考虑因素 成功地进行了这样的干预。整个急症护理医院的重症监护室 威斯康星州将参与这项阶梯楔形群随机对照试验。的具体目标， 拟议的研究是：1）确定FQ PPA对医院发作和医疗保健相关CDI的影响 与常规护理相比的比率和其他临床结局; 2）评价FQ PPA的实施情况 使用系统工程方法。对于目标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CDI以及其他重要临床 成果。对于目标2，将使用与医疗保健提供者的调查和访谈来评估背景， 实施和工作系统因素，有助于成功实施FQ PPA 干预除了解决迫切需要确定有效的AS战略，这项研究将提供 实施和评估其他预防HAI干预措施的框架。不管结果如何， 拟议的研究将产生广泛适用于AS倡议的数据、工具和方法， 卫生保健相关的感染预防。

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.