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

不必要的抗生素使用是对公共卫生和每个病人的威胁。减少不必要 使用或抗生素管理对于现在和将来保持抗生素的有效性至关重要 代最近的国家授权强调了建立抗生素管理的重要性 在医院和疗养院的计划，但我们不知道最好的方式来实施抗生素 在现实世界条件下进行广泛的管理。无症状菌尿（ASB），一种 患者的膀胱内有细菌定植，但没有任何泌尿系统症状，这是非常常见的情况 在住院病人和疗养院的居民。ASB经常与尿路感染（UTI）混淆， 但ASB与UTI不同，临床上无意义，不应使用抗生素治疗。不必要的筛查 ASB的治疗是医院和疗养院不必要使用抗生素的主要驱动因素。我们 制定了有效的干预措施，以实施循证抗生素管理指南， ASB通过连续的研究项目。我们现在建议使用这一工具来评估 两个大规模实施战略，一个虚拟学习协作（具有小组学习机会） 与技术援助相比（应要求提供个性化支持）。这两个实现 策略被广泛使用，但它们的有效性相互比较的随机对照试验， 罕见.在本试验中，我们将测试两种实施策略并观察临床结果。我们将 将提供医院和疗养院护理的VA医院随机分配到两个实施方案之一 战略布局VA医院将与VA抗菌药物管理工作组合作招募 （ASTF），一个致力于在所有VA工厂扩大抗生素管理活动的组织。我们立足 我们的学习健康周期计划，在其中我们与一个社区共享有关尿培养订单和抗生素使用的数据， 使每个医院人员都能掌握相关知识，从而减少尿培养订单和天数 抗生素，行为改变导致性能提高。我们的五年计划 大约20-25家医院通过一个周期的变化，同时建设能力，周期后继续 项目结束。这项工作将通过三个目标进行：（目标1）评估 实施. (Aim 2）比较虚拟学习协作与技术援助， 实施策略在一个集群随机试验。主要结果是在交付过程中花费的分钟数 但是我们也将通过减少尿培养和抗生素的使用来评估有效性。我们 将通过定性和定量分析，探讨利益攸关方对实施战略的满意度和可持续性 方法. (Aim 3）是透过预算影响评估推行策略的成本影响 分析.通过这项试验，我们将增加有关使用大规模实施战略的知识， 使抗生素管理计划在现实世界中取得成功。

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.