Preventing Opioid Overdose Mortality in the United States

我们建议由一位新的早期调查人员进行R01研究，以寻求理解和改进 在注射器服务计划(SSP)中实施纳洛酮以降低阿片类药物过量死亡率 美国。从2000年到2014年，年龄调整后的阿片类药物过量死亡率上升了近200%， 从2014年到2015年又增长了16%。这些数据表明，阿片类药物过量流行继续 在美国激增。纳洛酮是一种逆转阿片类药物的循证生物医学干预 过量，有效预防阿片类药物过量死亡。研究小组已经开发了一种实现 纳洛酮在包括SSP在内的各种设置中的实施手册。然而，只有15%的美国县拥有 最高的过量死亡率水平有一个以社区为基础的纳洛酮计划。 此外，只有56%的SSP--实施这种干预的最佳场所之一--有 已实施纳洛酮。对纳洛酮在SSP中的释放位置的细微差别的理解 实施过程的各个阶段--从探索和准备到实施和持续 (EPIS)-对集中干预努力至关重要。最近的一项系统审查得出结论，仅传播 这是必要的，但往往不足以推动预期的干预措施的通过。因此，有一个 迫切需要从经验上确定能够在传播后显著改进的执行战略 接近了。一种这样的策略--外部促进--在医疗环境中证明了有效性，但 还没有研究在实验中测试它在改善社区生物医学干预服务方面的作用。 基于SSP等组织。我们提出了外部促进干预，显示出改善 在艾滋病毒服务环境中实施，以确定纳洛酮的障碍和需求，并促进其启动 在SSP内交付。目标1是描述美国SSP在勘探、准备、实施、 以及提供纳洛酮干预的维持连续体。目标2是测试以下项目的有效性 外部促进以提高纳洛酮干预在EPIS连续体中的进展 美国SSP与单独传播实施手册进行了比较。为了实现目标1，我们将 对全美所有SSP(N=275)进行横断面研究。为了达到目标2，我们将 使用以下武器进行随机对照试验：(1)分发实施手册 和外部便利，为期12个月(试验性ARM)和(2)分发执行手册 仅限(控制臂)。所有尚未实施纳洛酮并有兴趣参与的SSP(估计N=100) 将以1：1的比例随机分配到学习臂。纳洛酮在EPIS中的研究进展 随机化12个月后，将通过调查对连续性进行评估。这些努力加在一起，可以改善 为过量用药高危人群提供纳洛酮，从而改善我国对阿片类药物的反应 吸毒过量流行。

We propose an R01 study by a new, early stage investigator that seeks to understand and improve naloxone implementation within syringe service programs (SSPs) to reduce opioid overdose mortality in the United States. The age-adjusted opioid overdose mortality rate rose nearly 200% from 2000 to 2014 and increased another 16% from 2014 to 2015. These data indicate that the opioid overdose epidemic continues to surge in the United States. Naloxone is an evidence-based biomedical intervention that reverses opioid overdose, effectively preventing opioid overdose mortality. The study team has developed an implementation manual for naloxone implementation in various settings including SSPs. Yet, only 15% of U.S. counties with the highest overdose mortality levels have a community-based, naloxone program operating within them. Furthermore, only 56% of SSPs, one of the best venues through which to implement this intervention, have implemented naloxone. A nuanced understanding of where naloxone delivery within SSPs falls along the four phases of the implementation process—from Exploration and Preparation to Implementation and Sustainment (EPIS)—is critical to focus intervention efforts. A recent systematic review concluded that dissemination alone is necessary but often insufficient to advance the desired adoption of interventions. There is, therefore, an urgent need to empirically identify implementation strategies that can significantly improve upon dissemination approaches. One such strategy—external facilitation—has demonstrated effectiveness in medical settings, but no research has experimentally tested its use to improve delivery of a biomedical intervention in community- based organizations such as SSPs. We propose an external facilitation intervention, shown to improve implementation in HIV service settings, to identify barriers to and needs for and facilitate start-up of naloxone delivery within SSPs. Aim 1 is to characterize U.S. SSPs along the exploration, preparation, implementation, and sustainment continuum for delivering the naloxone intervention. Aim 2 is to test the effectiveness of external facilitation to improve the advancement of the naloxone intervention along the EPIS continuum among U.S. SSPs compared with dissemination of the implementation manual alone. To achieve Aim 1, we will conduct a cross-sectional study with all SSPs (N=275) throughout the United States. To achieve Aim 2, we will conduct a randomized controlled trial with the following arms: (1) dissemination of an implementation manual and external facilitation for 12 months (experimental arm) and (2) dissemination of an implementation manual only (control arm). All SSPs not yet implementing naloxone and interested in participating (estimated N = 100) will be randomly assigned in a 1:1 ratio to the study arms. Advancement of naloxone along the EPIS continuum will be assessed via surveys 12 months post randomization. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.