School of Pharmacy, University of Wisconsin, Madison.
School of Medicine and Public Health, University of Wisconsin, Madison.
JAMA Netw Open. 2019 Sep 4;2(9):e199526. doi: 10.1001/jamanetworkopen.2019.9526.
IMPORTANCE: Suspicion of urinary tract infection (UTI) is the major driver of overuse and misuse of antibiotics in nursing homes (NHs). Effects of interventions to improve the recognition and management of UTI in NHs have been mixed, potentially owing to differences in how interventions were implemented in different studies. An improved understanding of how implementation approach influences intervention adoption is needed to achieve wider dissemination of antibiotic stewardship interventions in NHs. OBJECTIVE: To compare the effects of 2 implementation strategies on the adoption and effects of a quality improvement toolkit to enhance recognition and management of UTIs in NHs. DESIGN, SETTING, AND PARTICIPANTS: This cluster-randomized hybrid type 2 effectiveness-implementation clinical trial will be performed over a 6-month baseline (January to June 2019) and 12-month postimplementation period (July 2019 to June 2020). A minimum of 20 Wisconsin NHs with 50 or more beds will be recruited and randomized in block sizes of 2 stratified by rurality (rural vs urban). All residents who are tested and/or treated for UTI in study NHs will be included in the analysis. All study NHs will implement a quality improvement toolkit focused on enhancing the recognition and management of UTIs. Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback. Enhanced implementation is hypothesized to be associated with improvements in adoption of the quality improvement toolkit and clinical outcomes. Primary outcomes of the study will include number of (1) urine cultures per 1000 resident days and (2) antibiotic prescriptions for treatment of suspected UTI per 1000 resident-days. Secondary outcomes of the study will include appropriateness of UTI treatments, treatment length, use of fluoroquinolones, and resident transfers and mortality. A mixed-methods evaluation approach will be used to assess extent and determinants of adoption of the UTI quality improvement toolkit in study NHs. DISCUSSION: Knowledge gained during this study could help inform future efforts to implement antibiotic stewardship and quality improvement interventions in NHs. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03520010.
重要性：在养老院（NH）中，对尿路感染（UTI）的怀疑是过度和滥用抗生素的主要驱动因素。改善 NH 中 UTI 识别和管理的干预措施的效果参差不齐，这可能是由于不同研究中干预措施实施方式的差异所致。为了更广泛地推广 NH 中的抗生素管理干预措施，需要更好地了解实施方法如何影响干预措施的采用。
目的：比较两种实施策略对提高识别和管理 NH 中 UTIs 的质量改进工具包的采用和效果的影响。
设计、设置和参与者：这是一项为期 6 个月的基线期（2019 年 1 月至 6 月）和 12 个月的实施后期（2019 年 7 月至 2020 年 6 月）的集群随机混合 2 型有效性实施临床试验。将招募并随机分配至少 20 家威斯康星州 NH，每家 NH 有 50 张或更多床位，并按农村/城市分为 2 个分层的块大小。所有在研究 NH 中接受 UTI 检测和/或治疗的居民都将纳入分析。所有研究 NH 都将实施一项以提高对 UTIs 的识别和管理为重点的质量改进工具包。设施将根据外部促进（辅导）、协作同行学习和同行比较反馈随机分配到常规或增强的实施方法。假设增强实施与质量改进工具包的采用和临床结果的改善有关。该研究的主要结果将包括：（1）每 1000 名居民天的尿培养物数量和（2）每 1000 名居民天的治疗疑似 UTI 的抗生素处方数量。研究的次要结果将包括 UTI 治疗的适当性、治疗时间、氟喹诺酮类药物的使用以及居民转移和死亡率。将采用混合方法评估方法来评估研究 NH 中 UTI 质量改进工具包的采用程度和决定因素。
讨论：在这项研究中获得的知识可以帮助为未来在 NH 中实施抗生素管理和质量改进干预措施提供信息。
试验注册：ClinicalTrials.gov 标识符：NCT03520010。
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