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，VA 启动了全国阿片类药物过量教育和纳洛酮 在 VA 卫生部副部长的支持下开展 VA 的 OEND 计划 1。 卫生部副部长承认，迄今为止，大多数证据都围绕 OEND 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，而不是所有人 VA OEND 计划是第一个针对在医疗保健系统中接受阿片类镇痛药的患者的计划。 不同的患者群体：(1) 患有阿片类药物使用障碍的患者和 (2) 服用阿片类止痛药的患者。 截至 2016 年 5 月 22 日，退伍军人管理局设施已向每个退伍军人管理局的退伍军人分发了超过 27,000 个纳洛酮套件 参与纳洛酮分发的机构（VA 纳洛酮套件分发报告） 作为第一个大型医疗保健机构。 美国实施 OEND 系统，VA 在这方面有很多值得学习的地方 目前关于 OEND 实施的建议是否合理和/或是否应该进行调整 为了解决对 OEND 在医疗保健环境中有效性的担忧， 有必要对 OEND 进行评估，以检查它是否可以减少阿片类药物过量的风险 服用阿片类镇痛药的患者和患有阿片类药物使用障碍的患者。 目标：拟议的研究将实现以下目标： 目标 1：表征 VA 内纳洛酮的分布以及患者、处方者和环境相关的特征 与分布相关的因素。 目标 2：评估与类似风险退伍军人相比，纳洛酮是否分发给高危退伍军人 未接受纳洛酮的退伍军人与致命和非致命阿片类药物过量服用有关。 理论框架：范围、有效性、采用、实施和维护—RE-AIM— 该框架将指导我们的研究。该框架考虑了个人（例如患者）和机构层面。 评估干预措施影响时的（例如设置）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）到 2017 财年第一季度（2016 日历年年底），包括高危患者 人群：(1) 患有阿片类药物使用障碍的患者和 (2) 服用阿片类止痛药的高危患者。 目标 1：对于确定的队列，我们​​将从 VA 企业数据仓库 (CDW) 获取数据并 提供有关接受纳洛酮的患者、处方者的特征的描述性统计数据 纳洛酮，以及开纳洛酮的情况我们还将使用混合效应逻辑回归。 模型来识别患者、处方者和设置水平的患者之间的差异 接受纳洛酮。 目标 2：我们的主要分析将使用边际结构模型 (MSM) 来检验纳洛酮的效果 两组主要结果的分布：(1) 致命的阿片类药物过量——无意的、有意的和组合的 (2) 非致命性阿片类药物过量——无意、有意和联合使用 MSM。 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 倾向评分分析的原则。 不常见的观察结果（得到意想不到的待遇的人）。 体重增加，而常见观察结果体重减少。所有有风险的患者都将包含在我们的研究中。 分析，我们将从 VA/国防部 (DoD) 国家部门获得致命的服药过量结果 CDW 的死亡指数和非致命过量结果。 摘要：退伍军人管理局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 拟议的研究将描述这一创新计划的实施情况并进行评估。 纳洛酮的分配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。