A cluster randomized stepped-wedge trial to de-implement unnecessary post-operative antibiotics in children: the optimizing perioperative antibiotic in children (OPerAtiC) trial.
A cluster randomized stepped-wedge trial to de-implement unnecessary post-operative antibiotics in children: the optimizing perioperative antibiotic in children (OPerAtiC) trial.
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DOI：
10.1186/s13012-021-01096-1
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发表时间：
2021-03-19
期刊：
影响因子：
--
通讯作者：
Newland JG
中科院分区：
文献类型：
--
作者：
Malone S;McKay VR;Krucylak C;Powell BJ;Liu J;Terrill C;Saito JM;Rangel SJ;Newland JG
抗生素耐药性感染已成为一场公共卫生危机，这是由抗生素的不适当使用造成的。在美国，抗生素管理计划（ASP）已经建立，并被监管机构要求帮助解决抗生素耐药性问题。在被认为感染风险低的手术病例中，术后抗生素的使用是儿童中抗生素过度使用的一个领域。领先的公共卫生组织达成共识，制定了在低风险手术中消除术后抗生素的指南。然而，在这种情况下取消这些不适当抗生素的最佳策略尚不清楚。将在9家美国儿童医院进行一项为期3年的阶梯式楔形分组随机试验，以评估两种取消实施策略（订单集变更和促进培训）对低风险（即，清洁和清洁-污染）外科病例。促进培训将扩大订单集的变化，并将涉及与抗生素管理团队为期2天的研讨会。此次培训将由一名实施科学家专家（VRM）和一名具有抗生素管理专业知识的儿科传染病医生（JGN）领导。主要临床结局将是接受不必要的术后抗生素的手术病例的百分比。次要临床结局将包括手术部位感染率和艰难梭菌感染率，这是抗生素使用的常见不良后果。每月在每家医院进行半结构化访谈，评估两项战略的实施过程。主要实施结果是渗透率，渗透率定义为研究期间每家医院更改或开发的订单集数量。其他实施结果将包括ASP团队成员在实施过程中对每项战略的可接受性、适当性和可行性的评估。这项研究将提供关于两种潜在策略的影响的重要信息，以在评估重要的临床结果的同时，消除儿童术后不必要的抗生素使用。随着越来越多的不必要的医疗做法被发现，需要严格评估取消执行战略，包括便利化战略。沿着这项研究，需要其他严格设计的研究评估额外的战略，以进一步推进新兴的领域去执行。NCT 04366440。2020年4月28日注册，https://clinicaltrials.gov/ct2/show/NCT04366440。在线版本包含补充材料，可通过10.1186/s13012-021-01096-1获取。
Antibiotic-resistant infections have become a public health crisis that is driven by the inappropriate use of antibiotics. In the USA, antibiotic stewardship programs (ASP) have been established and are required by regulatory agencies to help combat the problem of antibiotic resistance. Post-operative antibiotic use in surgical cases deemed low-risk for infection is an area with significant overuse of antibiotics in children. Consensus among leading public health organizations has led to guidelines eliminating post-operative antibiotics in low-risk surgeries. However, the best strategies to de-implement these inappropriate antibiotics in this setting are unknown. A 3-year stepped wedge cluster randomized trial will be conducted at nine US Children’s Hospitals to assess the impact of two de-implementation strategies, order set change and facilitation training, on inappropriate post-operative antibiotic prescribing in low risk (i.e., clean and clean-contaminated) surgical cases. The facilitation training will amplify order set changes and will involve a 2-day workshop with antibiotic stewardship teams. This training will be led by an implementation scientist expert (VRM) and a pediatric infectious diseases physician with antibiotic stewardship expertise (JGN). The primary clinical outcome will be the percentage of surgical cases receiving unnecessary post-operative antibiotics. Secondary clinical outcomes will include the rate of surgical site infections and the rate of Clostridioides difficile infections, a common negative consequence of antibiotic use. Monthly semi-structured interviews at each hospital will assess the implementation process of the two strategies. The primary implementation outcome is penetration, which will be defined as the number of order sets changed or developed by each hospital during the study. Additional implementation outcomes will include the ASP team members’ assessment of the acceptability, appropriateness, and feasibility of each strategy while they are being implemented. This study will provide important information on the impact of two potential strategies to de-implement unnecessary post-operative antibiotic use in children while assessing important clinical outcomes. As more unnecessary medical practices are identified, de-implementation strategies, including facilitation, need to be rigorously evaluated. Along with this study, other rigorously designed studies evaluating additional strategies are needed to further advance the burgeoning field of de-implementation. NCT04366440. Registered April 28, 2020, https://clinicaltrials.gov/ct2/show/NCT04366440. The online version contains supplementary material available at 10.1186/s13012-021-01096-1.
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