Improving the Safety of Treatment for Hospitalized Patients with Alcohol Withdrawal Syndrome

项目总结/摘要 背景该提案的目标是改善酒精住院患者的预后 戒断综合征（AWS）。AWS在医院很常见，如果没有适当的管理，可能是致命的; 然而，AWS的治疗也有危险的副作用。次优治疗（持续躁动或 过度镇静）导致不良事件（例如，使用物理约束或机械通风）， 可能是可以避免的，但从未被研究过。此外，作为一线治疗的两种药物 治疗住院患者的AWS-苯二氮卓类药物和苯巴比妥-从来没有被严格比较， 住院病人。这两种治疗方法都是由临床医生自行决定的指南推荐的，但他们的 相对安全性仍然未知。候选人泰莎·斯蒂尔博士是一名重症监护医生， 国家专家小组制定一项全面的研究议程，以改善严重AWS的护理。 建议的K23建立在这个基础上，她以前的研究，显示了目前的治疗方法有很大的变化 住院AWS。RESEARCH.首先，Steel博士将研究住院医生如何以及为什么选择 使用苯二氮卓类药物与苯巴比妥治疗住院AWS，使用访谈和实施 理解供应商行为的科学框架。其次，她将评估不良事件的风险 (e.g.,使用身体约束）与苯二氮卓类药物和苯巴比妥相关， 住院患者，使用来自电子健康记录（EHR）的真实世界数据。这些研究将提供信息， 她的第三个目标是设计和试验一个实用的随机试验，嵌入医院护理，比较 苯二氮卓类药物与苯巴比妥的比较。试点将作为一个基础， 确定性多中心随机试验（Steel博士计划的R 01），以确定最安全的一线治疗， 住院AWS。职业发展。Steel博士的目标是成为一名创新的临床研究人员， 改善酒精使用障碍住院患者的预后。作为一名 作为一名独立的医生科学家，拟议中的K23奖提供了以下方面的基本培训：（1）定性研究 方法，（2）使用EHR数据的先进分析策略，以及（3）嵌入式 实用的临床试验斯蒂尔博士将在华盛顿大学（UW）进行她的研究， Katharine布拉德利博士是使用EHR数据进行混合方法研究的专家， 包括务实的审判。她将由Nicholas约翰逊博士共同指导，提供与以下方面相关的专业知识： 在医院环境中进行的临床试验和使用EHR的方法学专家Kevin Hallgren博士 用于临床AUD研究的数据。公共卫生影响。拟议的职业发展奖将 支持早期职业调查人员进行研究，以改善AWS的管理， 在美国，每年有3000名患者因该问题住院。

PROJECT SUMMARY/ABSTRACT BACKGROUND. The goal of this proposal is to improve outcomes for hospitalized patients with Alcohol Withdrawal Syndrome (AWS). AWS is common in hospitals and can be fatal without appropriate management; however, treatments for AWS also have dangerous side effects. Suboptimal treatment (persistent agitation or oversedation) leads to adverse events (e.g., use of physical restraints or mechanical ventilation), which are potentially avoidable but have never been studied. Moreover, the two types of medications used as first-line therapy for inpatient AWS—benzodiazepines and phenobarbital—have never been rigorously compared in hospitalized patients. Both treatments are recommended by guidelines at the discretion of clinicians, yet their comparative safety remains unknown. CANDIDATE. Dr. Tessa Steel is a critical care physician who co-led a national panel of experts to develop a comprehensive research agenda for improving the care of severe AWS. The proposed K23 builds on this foundation and her prior studies, showing wide variation in current treatments for inpatient AWS. RESEARCH. First, Dr. Steel will investigate how and why inpatient physicians choose to treat inpatient AWS with benzodiazepines versus phenobarbital, using interviews and an implementation science framework for understanding provider behavior. Second, she will evaluate the risk of adverse events (e.g., use of physical restraints) associated with benzodiazepines versus phenobarbital in diverse groups of hospitalized patients, using real-world data from electronic health records (EHRs). These studies will inform her third aim—to design and pilot a pragmatic randomized trial, embedded in hospital care, comparing benzodiazepines to phenobarbital for hospitalized patients with AWS. The pilot will serve as groundwork for a definitive multi-center randomized trial (Dr. Steel’s planned R01) to determine the safest first-line therapy for inpatient AWS. CAREER DEVELOPMENT. Dr. Steel’s goal is to be an innovative clinical researcher who improves outcomes for hospitalized patients with alcohol use disorder. To launch her career as an independent physician scientist, the proposed K23 award provides essential training in (1) qualitative research methods, (2) advanced analytic strategies for using EHR data, and (3) the design and conduct of embedded pragmatic clinical trials. Dr. Steel will conduct her research at the University of Washington (UW) under the primary mentorship of Dr. Katharine Bradley, who is an expert in mixed methods research using EHR data, including pragmatic trials. She will be co-mentored by Dr. Nicholas Johnson, providing expertise related to clinical trials conducted in hospital settings and Dr. Kevin Hallgren, a methodologic expert on the use of EHR data for clinical AUD research. PUBLIC HEALTH IMPACT. The proposed career development award will support an early-career investigator conducting research to improve management of AWS for the ~2 million patients hospitalized with this problem per year in the United States.