PATIENT SAFETY RESEARCH DURING NEONATAL CARE (R21)

 描述(申请人提供)：不良药物事件(ADE)每年伤害数百万患者，并给社会造成数十亿美元的损失。一种强大的安全文化被联系在一起 在重症监护病房环境中提供高质量的结果。与成年人相比，新生儿重症监护病房(NICU)中的婴儿患ADE的风险更高。在这种环境下，缺乏将实践和成果联系起来的多中心研究。需要一项大型研究来澄清实践和结果之间的联系，为前瞻性的、多中心的药物安全实践实施项目做准备。这项建议的中心目标是将具体的用药安全做法与具有国家代表性的电子病历(EMR)的短期不良事件和长期不良临床结果联系起来。史密斯博士将利用美国NICU中25%的婴儿的现有数据集来实现这一目标。通过与儿科医疗集团(Pediatrix Medical Group)的合作，他将使用一种全面的库存工具来评估NICU中的基线用药安全实践、ADE报告、ADE应对策略和ADE结果。然后，他将把这些数据与更广泛的Pediatrix EMR联系起来，以评估安全做法、短期不良事件和长期不良临床结果(包括死亡率和住院时间)之间的关系。该提案将：1)首次全面了解美国NICU在ADE预防和应对措施方面的差异；2)首次在多中心层面界定药物安全措施、ADE和临床结果之间的正负关联。如果这项提议成功，我们将确定可以广泛实施的最佳做法，以改善这一弱势群体的结果。

 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.