Effectiveness of a Rescue Medication in Preventing Opioid Overdose in Veterans

救援药物在预防退伍军人阿片类药物过量方面的有效性

• 批准号: 9757711
• 负责人: Elizabeth M. Oliva
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9757711
• 关键词: Acute; Address; Area; Assessment tool; Calendar; Cessation of life; Characteristics; Communities; Country; Data; Decision Making; Department of Defense; Education; Effectiveness; Epidemic; Evaluation; Funding; Goals; Health; Healthcare Systems; Heroin; Heroin Users; Individual; Intervention; Knowledge; Leadership; Logistic Regressions; Medical center; Mental Health; Mental Health Services; Methods; Modeling; Naloxone; Opioid; Opioid Analgesics; Opioid Antagonist; Outcome; Overdose; Patient Care; Patients; Persons; Pharmaceutical Preparations; Policy Maker; Probability; Public Health; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Recording of previous events; Reporting; Research; Risk; Risk Assessment; Selection Bias; Services; Structural Models; Time; Training; Training and Education; United States; Veterans; Weight; base; behavioral health; care systems; cohort; community setting; cost; data warehouse; effectiveness evaluation; health care settings; indexing; innovation; interest; meetings; mortality; operation; opioid misuse; opioid overdose; opioid use disorder; overdose risk; patient population; patient subsets; patients who use opioids; pharmacy benefit; prescription opioid; prevent; programs; sound; statistics; tool

Background: In Spring 2014 the VA launched a national Opioid Overdose Education and Naloxone Distribution (OEND) program with the support of the VA Under Secretary for Health1. In launching VA's OEND initiative, the Under Secretary for Health acknowledged that most of the evidence to date surrounds OEND targeting community-dwelling persons with documented opioid use disorders or opioid misuse rather than all patients receiving opioid analgesics in a health care system. The VA OEND program was the first to target two distinct patient populations: (1) patients with opioid use disorders and (2) patients prescribed opioid analgesics. As of May 22, 2016 VA facilities have dispensed just over 27,000 naloxone kits to Veterans with every VA facility participating in naloxone distribution (VA Naloxone Kit Distribution Report). As the first large health care system in the United States to implement OEND, there is a great deal that can be learned from VA in terms of whether current recommendations for OEND implementation are sound and/or whether they should be tailored to specific subsets of patients. To address concerns about the effectiveness of OEND in health care settings, an evaluation of OEND is necessary to examine whether it reduces opioid overdose as intended for at-risk patients prescribed opioid analgesics and patients with opioid use disorders. Objectives: The proposed study will pursue the following objectives: Objective 1: Characterize naloxone distribution within VA and patient-, prescriber-, and setting-related factors associated with distribution. Objective 2: Assess whether naloxone distribution to at-risk Veterans compared to similar at-risk Veterans who did not receive naloxone is associated with reduced fatal and non-fatal opioid overdose. Theoretical Framework: The Reach, Effectiveness, Adoption, Implementation, and Maintenance—RE-AIM— framework will guide our study. This framework considers both individual- (e.g., patient) and institutional-level (e.g., setting) factors when evaluating the impact of interventions. Methods: We will identify a cohort of patients from Fiscal Year 2014 Quarter 3 (FY2014 Q3; the start of the national OEND program) through FY2017 Q1 (end of calendar year 2016) comprising at-risk patient populations: (1) patients with opioid use disorders and (2) at-risk patients prescribed opioid analgesics. Objective 1: For the identified cohort, we will obtain data from the VA Corporate Data Warehouse (CDW) and provide descriptive statistics on the characteristics of patients who receive naloxone, prescribers who prescribe naloxone, and settings in which naloxone is prescribed. We will also use mixed-effects logistic regression models to identify patient-, prescriber-, and setting-level differences between patients who do and do not receive naloxone. Objective 2: Our primary analysis will use marginal structural models (MSMs) to examine the effect of naloxone distribution for two main sets of outcomes: (1) Fatal opioid overdose—unintentional, intentional, and combined and (2) Non-fatal opioid overdose—unintentional, intentional, and combined. MSMs are a method for controlling for selection bias by using inverse probability of treatment weights which follow many of the same principles as propensity score analysis. Uncommon observations (persons who get the unexpected treatment) get greater weight, and common observations get less weight. All at-risk patients will be included in our analyses and we will obtain fatal overdose outcomes from the VA/Department of Defense (DoD) National Death Index and non-fatal overdose outcomes from CDW. Summary: The VA is leading the nation with regards to health care system-based implementation of naloxone distribution. The proposed study will characterize implementation of this innovative program and assess whether naloxone distribution is meeting its intended goal of reducing opioid overdose among at-risk Veterans.

背景：2014年春季，退伍军人管理局启动了全国阿片类药物过量教育和纳洛酮 分发（OEND）计划与退伍军人事务部副部长卫生1的支持。在启动VA的OEND时， 卫生部副部长承认，迄今为止，大多数证据都围绕着开放教育结束计划 针对有记录的类阿片使用障碍或类阿片滥用的社区居民， 在卫生保健系统中接受阿片类镇痛药的患者。VA OEND计划是第一个针对两个 不同的患者人群：（1）阿片类药物使用障碍患者和（2）处方阿片类镇痛药的患者。 截至2016年5月22日，VA设施已向每个VA的退伍军人分发了超过27，000个纳洛酮套件 参与纳洛酮分销的机构（VA纳洛酮套件分销报告）。作为第一个大型医疗保健 系统在美国实施OEND，有很多可以从VA方面学习， 目前关于实施开放式终端的建议是否合理和/或是否应加以调整 对特定的患者子集。为了解决对OEND在医疗保健环境中的有效性的担忧， 有必要对OEND进行评价，以检查其是否能减少阿片类药物过量， 处方阿片类镇痛药的患者和阿片类药物使用障碍患者。 目标：拟议研究将追求以下目标： 目的1：描述纳洛酮在VA内的分布以及患者、处方者和设置相关性 与分布有关的因素。 目的2：评估纳洛酮是否分布到风险退伍军人相比，类似的风险 未接受纳洛酮的退伍军人与减少致命性和非致命性阿片类药物过量有关。 理论框架：可及性、有效性、采用、实施和维护 框架将指导我们的研究。该框架考虑了个人（例如，患者）和机构一级 (e.g.,在评估干预措施的影响时，应考虑到环境因素。 方法：我们将从2014财年第3季度（2014财年第3季度; 国家OEND计划），包括高危患者 人群：（1）阿片类药物使用障碍患者和（2）处方阿片类镇痛药的高危患者。 目标1：对于确定的队列，我们将从VA公司数据仓库（CDW）获取数据， 提供关于接受纳洛酮治疗的患者、开处方的处方者 而其中的“舍”，就是“舍”的意思。我们还将使用混合效应logistic回归 模型，以识别患者、处方者和设置水平之间的差异 接受纳洛酮。 目的2：我们的初步分析将使用边缘结构模型（MSM）来检查纳洛酮的作用 两组主要结果的分布：（1）致死性阿片类药物过量-无意、有意和合并 和（2）非致命性阿片类药物过量-无意的，故意的，和组合。MSM是一种方法， 通过使用治疗权重的逆概率来控制选择偏差， 倾向评分分析的原则。不常见的观察结果（接受非预期治疗的患者） 得到更大的权重，而普通观测得到的权重较小。所有有风险的患者都将被纳入我们的 分析，我们将获得致命的过量结果从VA/国防部（DoD）国家 CDW的死亡指数和非致死性过量结局。 总结：VA在基于医疗保健系统的纳洛酮实施方面处于全国领先地位 分布拟议的研究将描述这一创新计划的实施情况，并评估 纳洛酮的分布是否达到了减少高危退伍军人中阿片类药物过量的预期目标。