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.

项目概要/摘要背景该提案的目标是改善住院酒精患者的治疗结果。戒断综合症 (AWS) 在医院中很常见，如果没有适当的管理，可能会致命；然而，AWS 的治疗也有危险的副作用（持续的躁动或不理想的治疗）。过度镇静）会导致不良事件（例如，使用身体约束或机械通气），这些不良事件可能可以避免，但从未被研究过，这两种药物被用作一线药物。住院患者 AWS 的治疗方法——苯二氮卓类药物和苯巴比妥——从未在这两种治疗方法均由指南推荐，但患者自行决定。相对安全性仍未知。国家专家小组制定了一项全面的研究议程，以改善严重 AWS 的护理。拟议的 K23 建立在这一基础和她之前的研究之上，显示当前治疗方法存在很大差异首先，Steel 博士将调查住院医生选择的方式和原因。通过访谈和实施，使用苯二氮卓类药物与苯巴比妥治疗住院 AWS 其次，她将评估不良事件的风险。在不同群体中，与苯二氮卓类药物和苯巴比妥相关的（例如，使用身体束缚）这些研究将利用电子健康记录 (EHR) 中的真实数据为住院患者提供信息。她的第三个目标是设计和试点一项实用的随机试验，嵌入医院护理中，比较该试点项目将作为 AWS 住院患者的苯二氮卓类药物与苯巴比妥治疗的基础。确定性多中心随机试验（Steel 博士计划的 R01），以确定最安全的一线治疗住院病人 AWS 的职业发展。 Steel 博士的目标是成为一名创新的临床研究员。改善住院酒精使用障碍患者的治疗结果，开始她的职业生涯。独立医师科学家，拟议的 K23 奖项提供以下方面的基本培训：(1) 定性研究方法，(2) 使用 EHR 数据的高级分析策略，以及 (3) 嵌入式的设计和实施 Steel 博士将在华盛顿大学 (UW) 进行实用的临床试验。凯瑟琳·布拉德利 (Katharine Bradley) 博士是使用 EHR 数据进行混合方法研究的专家，她将由尼古拉斯·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 EHR 使用方法学专家 Kevin Hallgren 博士拟议的职业发展奖将用于临床 AUD 研究的数据。支持早期职业调查员开展研究，以改善 AWS 的管理，造福约 200 万人在美国，每年都有因该问题住院的患者。