PATIENT SAFETY RESEARCH DURING NEONATAL CARE (R21)

 药物不良事件（ADE）每年伤害数百万患者，并使社会损失数十亿美元。强大的安全文化与 在重症监护室环境中获得高质量的结果。新生儿重症监护室（NICU）中的婴儿与成人相比，发生ADE的风险更高。缺乏在这种环境下将实践和结果联系起来的多中心研究。需要进行一项大型研究，以澄清实践与结果之间的关联，为前瞻性、多中心药物安全实践实施项目做准备。该提案的中心目标是将特定的药物安全实践与具有全国代表性的电子病历（EMR）中的短期不良事件和长期不良临床结局联系起来。史密斯博士将通过使用来自美国25%的新生儿重症监护室婴儿的现有数据集来实现这一目标。通过与Pediatrix医疗集团（由美国276个NICU组成，包括900名儿科医生）的合作，他将使用全面的库存工具来评估NICU的基线药物安全实践，ADE报告，ADE应对策略和ADE结果。然后，他将这些数据与更广泛的Pediatrix EMR联系起来，以评估安全实践、短期不良事件和长期不良临床结局（包括死亡率和住院时间）之间的关联。这项建议将：1）首次全面了解美国NICU在ADE预防和应对实践方面的差异，2）首次在多中心水平上定义药物安全实践、ADE和临床结局之间的积极和消极关联。如果这一建议获得成功，我们将确定可广泛实施的最佳做法，以改善这一弱势群体的成果。

 DESCRIPTION (provided by applicant): Adverse drug events (ADEs) injure millions of patients and cost society billions of dollars each year. A strong culture of safety has been linked with quality outcomes across Intensive Care Unit environments. Infants in the neonatal intensive care unit (NICU) are at even higher risk of ADEs compared to adults. Multi-center research linking practices and outcomes in this environment is lacking. A large study is needed to clarify the associations between practices and outcomes in preparation for a prospective, multi-center medication safety practice implementation project. The central objective of this proposal is to link specific medication safety practices with short-term adverse events and long-term adverse clinical outcomes from a nationally representative electronic medical record (EMR). Dr. Smith will accomplish this objective by using an existing dataset from 25% of the infants admitted to a NICU in the United States. Through a partnership with the Pediatrix Medical Group, composed of 276 NICUs in the U.S. encompassing 900 neonatologists, he will use a comprehensive inventory tool to assess baseline medication safety practices, ADE reporting, ADE response strategies, and ADE outcomes across NICUs. He will then link these data with the broader Pediatrix EMR to evaluate associations between safety practices, short-term adverse event and long-term adverse clinical outcomes including mortality and length of stay. This proposal will: 1) provide the first comprehensive understanding of how U.S. NICUs vary in their ADE prevention and response practices and 2) define for the first time both positive and negative associations between medication safety practices, ADEs, and clinical outcomes at the multi-center level. If this proposal is successful, we will identify best-practices that can be broadly implemented to improve outcomes in this vulnerable population.