Effectiveness of a Rescue Medication in Preventing Opioid Overdose in 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 在退伍军人事务部卫生部副部长的支持下实施分销(OEND)计划。在推出退伍军人管理局的OEND时 关于这一倡议，卫生部副部长承认，到目前为止，大多数证据都围绕着新陈代谢综合征 针对有记录的阿片类药物使用障碍或阿片类药物滥用的社区居民，而不是所有 在卫生保健系统中接受阿片类镇痛剂治疗的患者。VA OEND计划是第一个针对两个人的计划 不同的患者群体：(1)阿片类药物使用障碍患者和(2)使用阿片类止痛药的患者。 截至2016年5月22日，退伍军人管理局向退伍军人分发了略高于27,000个纳洛酮试剂盒 参与纳洛酮分配的机构(VA纳洛酮试剂盒分配报告)。作为第一个大型医疗保健 在美国实施OEND系统，在以下方面可以从退伍军人管理局学到很多东西 目前实施OEND的建议是否合理和/或是否应该量身定做 到特定的患者亚群。为了解决人们对OEND在卫生保健环境中的有效性的担忧， 有必要对OEND进行评估，以检查它是否像高危人群预期的那样减少阿片类药物过量 患者开阿片类止痛药和阿片类药物使用障碍患者。 目标：拟议的研究将追求以下目标： 目标1：研究纳洛酮在退伍军人中的分布以及与患者、处方者和环境相关的情况 与分配相关的因素。 目标2：评估纳洛酮在高危退伍军人和类似高危退伍军人中的分布 没有接受纳洛酮的退伍军人与致命和非致命阿片类药物过量的减少有关。 理论框架：覆盖范围、有效性、采用、实施和维护-RE-AIM- 框架将指导我们的研究。这一框架同时考虑了个人(例如，患者)和机构层面 评估干预措施影响时的(例如，环境)因素。 方法：我们将确定2014财年第三季度(2014财年第三季度； 国家OEND计划)至2017财年第一季度(2016日历年末)，包括高危患者 人群：(1)阿片类药物使用障碍患者和(2)高危患者使用阿片类止痛药。 目标1：对于已确定的队列，我们将从退伍军人事务部数据仓库(CDW)和 提供关于接受纳洛酮的患者的特征的描述性统计数据，处方人员 纳洛酮，以及处方纳洛酮的设置。我们还将使用混合效应Logistic回归 确定患者、处方者和设置水平差异的模型 接受纳洛酮治疗。 目标2：我们的初步分析将使用边际结构模型(MSM)来检验纳洛酮的作用 两组主要结果的分布：(1)致命性阿片类药物过量--无意、故意和联合 和(2)非致命性阿片类药物过量--无意、故意和联合使用。MSM是一种 通过使用遵循许多相同的处理权重的逆概率来控制选择偏差 作为倾向性得分分析的原则。不寻常的观察(接受意外治疗的人) 获得更大的权重，而常见的观察结果获得更少的权重。所有高危患者都将包括在我们的 分析，我们将从退伍军人事务部/国防部(DoD)国家获得致命的过量结果 死亡指数和CDW的非致命性过量结果。 摘要：退伍军人管理局在基于医疗系统的纳洛酮实施方面处于全国领先地位 分发。拟议的研究将描述这一创新方案的实施情况，并评估 纳洛酮的分配是否达到了减少有风险的退伍军人中阿片类药物过量的预期目标。

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.