RELAX: Reducing Length of Antibiotics For Children With Ear Infections

项目摘要/摘要： 急性中耳炎(AOM)是儿童最常见的抗生素适应症，占24%。 在所有儿科抗生素处方中，有60%的儿童在3岁前受到影响。对于大多数儿童来说，≥2 患有AOM的年龄，5-7天而不是10天的抗生素已经被证明是足够的，并且 导致较少的不良药物事件，具有类似的失败和复发率。因此，国家指导方针 对于这个年龄段的非严重AOM，建议使用短疗程的抗生素。尽管如此 推荐，≥；94%的2岁儿童开的抗生素比推荐的时间长 这个年龄段的AOM持续时间和超过41%的抗生素暴露天数可能是不必要的。在一个 最近的一项初步研究，将低成本高强度干预与个性化临床医生教育进行了比较 通过同行比较和电子健康记录(EHR)更改处方进行临床医生审核和反馈 对仅有EHR变化的领域进行低强度干预，开出推荐的短抗生素 持续时间显著增加(76%和50%，绝对百分比)。需要进行一项明确的研究 就实施哪些干预措施提出适当建议，同时将资源利用率降至最低。这个 这项研究的总体目标是评估两个低成本方案的有效性和实施结果 不同力度务实干预增加推荐短小抗菌药物处方 2岁及以上儿童的AOM持续时间。一项多中心整群随机对照试验 将使用第二类混合执行效力设计来评估干预措施。高强度的 干预措施包括临床医生教育、个性化临床医生审计和与同行比较的反馈， 而低强度干预将包括临床医生教育 而EHR也发生了变化。总共有46家社区诊所和/或紧急护理中心分布在两个不同的 美国的地理区域将随机接受两种干预措施之一。实用的 将使用稳健的实施和可持续模式来指导实施和范围 将使用有效性采用执行维护框架来评估结果。一种混合的- 将在实施前和评估阶段使用方法方法，并将使用量化 分析、半结构化访谈、焦点小组、调查和成本分析。国家利益攸关方在 美国儿科学会和疾病控制和预防中心将协助 传播调查结果和扩大干预范围。

PROJECT SUMMARY/ABSTRACT: Acute otitis media (AOM) is the most commonly cited indication for antibiotics in children, accounting for 24% of all pediatric antibiotic prescriptions and affecting 60% of children by 3 years of age. For most children ≥ 2 years of age with AOM, 5-7 days, rather than 10 days, of antibiotics have been shown to be sufficient and result in fewer adverse drug events with similar failure and recurrence rates. Thus, national guidelines recommend short durations of antibiotics for non-severe AOM in this age group. Despite these recommendations, >94% of children ≥2 years of age are prescribed longer than recommended antibiotic durations and over 41% of antibiotic exposure days for AOM in this age group are likely unnecessary. In a recent pilot study that compared a low-cost High-intensity intervention with clinician education, individualized clinician audit and feedback with peer comparison and electronic health record (EHR) changes of prescription fields to a Low-intensity intervention with only EHR changes prescribing of recommended short antibiotic durations increased significantly (76% and 50%, absolute percentage). A definite study is needed to make appropriate recommendations on which intervention to implement, while minimizing resource utilization. The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost pragmatic interventions of different intensities to increase prescribing of recommended short antibiotic durations for AOM for children 2 years of age and older. A multi-center cluster randomized controlled trial using a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and EHR changes of prescription fields, whereas the Low-intensity intervention will include clinician education and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct geographic regions in the United States will be randomized to one of the two interventions. The Practical Robust Implementation and Sustainability Model will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance framework will be used to evaluate outcomes. A mixed- methods approach will be used in the pre-implementation and evaluation phases and will utilize quantitative analyses, semi-structured interviews, focus groups, surveys, and cost analyses. National stakeholders at the American Academy of Pediatrics and the Centers for Disease Control and Prevention will assist with dissemination of findings and scaling of interventions.