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

提高住院酒精戒断综合症患者的治疗安全性

基本信息

批准号：
10706543
负责人：
Tessa Lynne Steel
金额：
$ 18.8万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-20 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10706543
关键词：
Academic Medical Centers Adverse effects Adverse event Affect Age Agitation Alcohol withdrawal syndrome Automobile Driving Belief Benzodiazepines Caring Clinical Clinical Data Community Hospitals Conduct Clinical Trials County Critical Care Dangerousness Data Delirium Disease Dose Electronic Health Record Equipoise Feedback Foundations Goals Group Hospitalization Guidelines Health Personnel Health system Hospitalization Hospitals Impaired cognition Inpatients Interview Investigation K-Series Research Career Programs Knowledge Measures Mechanical ventilation Medical center Medical emergency Medicine Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Methodology Myocardial Infarction Patients Pharmaceutical Preparations Phenobarbital Physical Restraint Physicians Practice Guidelines Pragmatic clinical trial Procedures Process Provider Public Health Qualitative Research Randomized Randomized, Controlled Trials Recommendation Research Research Methodology Research Personnel Retrospective cohort Risk Safety Scientist Severity of illness Steel Structure Testing Theoretical Domains framework Training Treatment Protocols United States Universities Variant Ventilatory Depression Washington Work advanced analytics adverse event risk alcohol abuse therapy alcohol use disorder arm career career development comparative safety design electronic health data high risk hospital care implementation framework improved improved outcome innovation intervention refinement medical specialties medication safety mortality multidisciplinary patient subsets pragmatic randomized trial pragmatic trial provider behavior provider factors randomized trial response safety net side effect training opportunity trauma centers treatment effect

项目摘要

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.

项目摘要/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Steel博士将在华盛顿大学（UW）进行研究 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。