A Cluster Randomized Trial of Two Implementation Strategies to Disseminate a Successful Antibiotic Stewardship Intervention

两种实施策略的整群随机试验，以传播成功的抗生素管理干预措施

• 批准号: 10410258
• 负责人: BARBARA Wells TRAUTNER
• 金额: $ 49.91万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10410258
• 关键词: Cluster; Randomized; Trial; Two; Implementation

Unnecessary antibiotic use is a threat to public health and to each individual patient. Reducing unnecessary use, or antibiotic stewardship, is essential to preserving the effectiveness of antibiotics now and for future generations. Recent national mandates underscore the importance of establishing antibiotic stewardship programs in hospitals and nursing homes, but we do not know the best way to implement antibiotic stewardship on a wide scale and under real-world conditions. Asymptomatic bacteriuria (ASB), a condition in which the patient has bacteria colonizing the bladder without any urinary symptoms, is very common condition in hospitalized patients and nursing home residents. ASB is often confused with urinary tract infection (UTI), but ASB, unlike UTI, is clinically insignificant and should not be treated with antibiotics. Unnecessary screening for and treatment of ASB is a major driver of unnecessary antibiotic use in hospitals and nursing homes. We have developed an effective intervention to implement evidence-based antibiotic stewardship guidelines for ASB through successive research projects. We now propose to use this tool to assess the relative merits of two large-scale implementation strategies, a virtual learning collaborative (with group learning opportunities) compared to technical assistance (individualized support available on request). These two implementation strategies are widely used, but randomized, controlled trials of their effectiveness compared to each other are rare. In this trial we will test the two implementation strategies and observe clinical outcomes. We will randomize VA hospitals that provide both hospital and nursing home care to one of the two implementation strategies. VA hospitals will be recruited in partnership with the VA Antimicrobial Stewardship Task Force (ASTF), an organization dedicated to expanding antibiotic stewardship activities across all VA sites. We base our plans on a learning health cycle, in which we share data about urine culture orders and antibiotic use with a lead person at each hospital to generate knowledge, which leads to fewer urine culture orders and fewer days of antibiotics, and behavior change leads to improved performance. Our five-year project will take approximately 20-25 hospitals through one cycle of change, while building capacity for cycles to continue after the project ends. The work will occur through three aims: (Aim 1) Assess context and resources for implementation. (Aim 2) Compare a virtual learning collaborative versus technical assistance as implementation strategies in a cluster randomized trial. The primary outcome is minutes spent in delivery of the intervention, but we will also assess effectiveness through decreased urine cultures and antibiotic use. We will explore stakeholder satisfaction with and sustainability of implementation strategies through qualitative methods. (Aim 3) is to assess the cost implications of the implementation strategies through budget impact analysis. Through this trial, we will add to knowledge about using wide scale implementation strategies and making antibiotic stewardship programs successful in real-world settings.

不必要的抗生素使用是对公共卫生和每个患者的威胁。减少不必要的 使用或抗生素管理对于现在和将来保留抗生素的有效性至关重要 几代人。最近的国家授权强调了建立抗生素管理的重要性 医院和疗养院的计划，但我们不知道实施抗生素的最佳方法 在大规模和现实情况下的管理。无症状细菌（ASB），一种条件 患者患有细菌在没有任何泌尿症状的情况下定居膀胱，是非常普遍的状况 在住院的患者和疗养院居民中。 ASB通常与尿路感染（UTI）相混淆， 但是与UTI不同的ASB在临床上是微不足道的，不应用抗生素治疗。不必要的筛选 对于ASB的治疗和治疗是医院和疗养院中不必要的抗生素使用的主要驱动力。我们 已经开发了有效的干预措施来实施基于证据的抗生素管理指南 通过连续的研究项目ASB。现在，我们建议使用此工具来评估 两种大规模实施策略，一种虚拟学习协作（具有小组学习机会） 与技术援助相比（根据要求提供个性化支持）。这两个实现 策略被广泛使用，但相比的随机，对照试验是 稀有的。在此试验中，我们将测试两种实施策略并观察临床结果。我们将 随机将VA医院随机提供医院和疗养院护理 策略。 VA医院将与VA抗菌管理工作组合作招募 （ASTF），一个致力于扩大所有VA站点的抗生素管理活动的组织。我们基础 我们关于学习健康周期的计​​划，在该周期中，我们与尿液培养订单和抗生素使用的数据与 每家医院的领导者产生知识，这导致尿液培养订单较少，较少的天数 抗生素和行为变化会改善性能。我们的五年项目将接受 通过一个变化周期，大约20-25家医院，同时建立能力以使周期在 项目结束。这项工作将通过三个目的进行：（目标1）评估上下文和资源 执行。 （目标2）将虚拟学习协作与技术援助进行比较 集群随机试验中的实施策略。主要结果是花在交付 干预措施，但我们还将通过减少尿培养和抗生素使用来评估有效性。我们 将通过定性探索利益相关者对实施策略的满意度和可持续性 方法。 （目标3）是通过预算影响评估实施策略的成本影响 分析。通过这项试验，我们将增加有关使用大规模实施策略的知识和 使抗生素管理计划在现实世界中取得成功。