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 据估计，美国国内急性护理医院的超额成本为48亿美元。有效的感染控制 措施和抗生素管理(AS)是医疗机构持续控制CDI的基础。 迫切需要确定和实施专门针对CDI的战略，将重点放在 减少抗生素的使用与增加CDI的风险高度相关，如氟喹诺酮类药物(FQ)。 处方前授权(PPA)和带反馈的处方后评审是两种核心策略。 然而，尚不清楚1)哪些AS策略在具体减少CDI方面最有效，以及2)如何 有效地实施AS战略。如果不解决这些关键差距，CDI预防将继续滞后。 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，促进适当使用抗生素，减少耐药传播 细菌。这将有助于实现减轻CDI负担的长期目标，这是#年必不可少的一步。 提高医疗保健的安全性和质量。FQ PPA是一种特别有前景的减少CDI的AS策略。 虽然FQS是住院急救机构中最常用的抗生素类别之一，但 与CDI的风险密切相关，在流行环境中，FQ的使用并不是控制努力的重点 在美国。拟议的研究将使用有效性-实施混合类型2设计，以同时 评估FQ PPA干预措施降低CDI的有效性，以及以下关键考虑因素 成功实施这样的干预。急诊医院的重症监护室 威斯康星州将参加这项阶梯式楔形群随机对照试验。该计划的具体目标 建议的研究是：1)确定FQ PPA对医院发病和与医疗保健相关的CDI的影响 与常规护理的比率和其他临床结果进行比较；以及2)评估FQ PPA的实施情况 使用系统工程的方法。对于目标1，将使用电子健康记录数据来评估 FQ PPA对医院发病和医疗保健相关CDI以及其他重要临床疾病的影响 结果。对于目标2，将使用调查和与医疗保健提供者的访谈来评估背景， 实施，以及有助于成功实施FQ PPA的工作系统因素 干预。除了解决确定有效的AS战略的迫切需要外，这项研究还将提供 实施和评估预防禽流感的其他干预措施的框架。无论结果如何， 拟议的研究将产生具有广泛适用性的数据、工具和方法，用于 医疗保健相关感染预防。

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.