Optimizing Pain Management in End-Stage Renal Disease Among Veterans (OPERA-Vets):Balancing Benefits and Harms of Opioids

背景：在过去十年中，退伍军人事务部实施了阿片类药物政策，最引人注目的是2013年的阿片类药物安全 倡议，旨在解决迅速增长的阿片类药物危机。随着钟摆从阿片类药物摇摆而来 在开处方时，一些严重疾病的患者可能会经历意外的情况 后果，包括无法控制的疼痛，即使其他人可能已经避免了潜在的并发症 阿片类药物的使用。本项目研究这些政策对终末期肾病退伍军人的潜在影响。 疾病(ESRD)，约有35,000名退伍军人，他们权衡了 阿片类药物可能特别具有挑战性。这些退伍军人的预期寿命非常有限，而且 疼痛负担，与患有转移性癌症的退伍军人相当，但往往被低估。他们在那里 阿片类药物相关严重不良事件(SAE；例如阿片类药物过量)的风险增加。然而，与其他 病情严重的人群，他们可依赖的非阿片类止痛药替代品较少，可能面临 非药物性疼痛管理策略的障碍。此外，大多数患有终末期肾病的退伍军人会收到 在退伍军人管理局社区护理或医疗保险下的社区透析，使他们暴露在潜在的 护理碎片化对阿片类药物安全和疼痛控制的不利影响。 意义/影响：了解退伍军人管理局改善阿片类药物在人群中安全的倡议的影响 对患有严重疾病的退伍军人的水平对于退伍军人管理局确保这些弱势群体的承诺至关重要 退伍军人得到的护理可以缓解令人痛苦的症状。这里提出的工作是对 弗吉尼亚州卫生部副部长的首要任务是改善疼痛管理和止痛药的安全性。 创新：拟议中的研究是第一次检查阿片类药物安全倡议和处方的影响 关于一群重病退伍军人的指导方针。它利用VA数据，其中包括丰富的疼痛控制措施 不能从任何其他国家数据来源获得。序贯解释性混合方法研究的使用 设计在当代背景下对疼痛管理的定量和定性结果进行三角测量 阿片类药物政策是对阿片类药物研究领域的新贡献。 具体目标：1)检查疼痛管理策略、与阿片类药物相关的SAE和疼痛控制的变化 2010-2018年患有终末期肾病的退伍军人中；2)比较不同透析设置对阿片类药物相关SAE的影响 (弗吉尼亚州、弗吉尼亚州-社区护理、医疗保险)2010-2018年；3)引出退伍军人的观点和经历 与ESRD和护理他们的临床医生一起在VA阿片类药物安全的背景下进行疼痛管理 倡议，以便为政策和实践提供信息。 研究方法：本研究采用顺序解释性混合方法设计。的数量部分 这项研究(目标1和2)包括2010至2018年间所有退伍军人接受透析的所有退伍军人。我们会 对关联的VA、Medicare和USRDS数据执行中断的时间序列分析，以检查 患有ESRD的退伍军人在疼痛治疗(阿片类药物、非阿片类药物、非药物类药物)、阿片类药物- 自2013年OSI以来，随着时间的推移，总体上和通过透析设置，出现了相关的严重不良反应和疼痛。到时候我们会的 对患有ESRD和VA的退伍军人进行半结构化访谈，这些医生照顾ESRD患者 确定改善退伍军人病痛管理政策和实践的机会(目标3)。 实施/下一步：我们将与我们的业务合作伙伴咨询委员会合作，确保我们的 研究将向政策提供关于如何最佳地将阿片类药物安全倡议与疼痛管理相结合的信息 指导方针，以满足患有终末期肾病和其他严重疾病的退伍军人的需求。我们将合作 与董事会共同制定一份“路线图”，总结我们的主要发现，确定对政策和 临床护理，并确定未来旨在优化疼痛控制的临床和政策干预的优先事项 患有终末期肾病的退伍军人。这一路线图很可能适用于其他重病退伍军人群体。

Background: Over the past decade, VA has implemented opioid policies, most notably the 2013 Opioid Safety Initiative, designed to address the burgeoning opioid crisis. As the pendulum has swung away from opioid prescribing, it is possible that some patients with serious illness may have experienced unintended consequences, including uncontrolled pain, even while others may have avoided potential complications of opioid use. This project examines the potential impact of these policies on Veterans with end-stage renal disease (ESRD), a population of approximately 35,000 Veterans for whom balancing the benefits and harms of opioids may be particularly challenging. These Veterans have very limited life expectancy and a substantial pain burden, comparable to Veterans with metastatic cancer, but often under-appreciated. They are at increased risk of opioid-related serious adverse events (SAE; e.g. opioid overdose). Yet compared with other seriously-ill populations, they have fewer non-opioid analgesic alternatives to fall back on and may face barriers to non-pharmacologic pain management strategies. Moreover, most Veterans with ESRD receive dialysis in the community either under VA Community Care or Medicare, exposing them to the potential adverse impact of care fragmentation on opioid safety and pain control. Significance/Impact: Understanding the impact of VA initiatives to improve opioid safety at the population level on Veterans with serious illness is critical to the VA’s commitment to ensure that these vulnerable Veterans are provided care that relieves distressing symptoms. The work proposed here is responsive to the VA Under Secretary for Health’s priority to improve pain management and the safety of pain medications. Innovation: The proposed study is the first to examine the impact of opioid safety initiatives and prescribing guidelines on a group of seriously-ill Veterans. It leverages VA data that include rich measures of pain control unavailable from any other national data source. The use of a sequential explanatory mixed-methods study design to triangulate quantitative and qualitative findings on pain management in the context of contemporary opioid policy is a novel contribution to the field of opioid research. Specific Aims: 1) Examine changes in pain management strategies, opioid-related SAE, and pain control among Veterans with ESRD from 2010-2018; 2) Compare changes in opioid-related SAE by setting of dialysis (VA, VA-Community Care, Medicare) from 2010-2018; 3) Elicit the perspectives and experiences of Veterans with ESRD and the clinicians who care for them related to pain management in the context of VA opioid safety initiatives in order to inform policy and practice. Methodology: The study employs a sequential explanatory mixed-methods design. The quantitative portion of the study (Aims 1 and 2) includes Veterans on dialysis across all VAs between 2010 and 2018. We will conduct an interrupted time series analysis of linked VA, Medicare, and USRDS data to examine whether Veterans with ESRD have had changes in pain therapies (opioids, non-opioids, non-pharmacologic), opioid- related serious adverse, and pain, overall and by setting of dialysis, over time since the 2013 OSI. We will then conduct semi-structured interviews with Veterans with ESRD and VA clinicians who care for ESRD patients to identify opportunities for improvement in VA pain management policy and practice (Aim 3). Implementation/Next Steps: We will work with our Advisory Board of operational partners, to ensure that our research will inform policy about how to optimally align opioid safety initiatives and pain management guidelines to meet the needs of Veterans with ESRD and those with other serious illnesses. We will collaborate with the Board to develop a ‘roadmap” that will summarize our key findings, identify implications for policy and clinical care, and identify priorities for future clinical and policy intervention intended to optimize pain control for Veterans with ESRD. This roadmap can likely be adapted for other groups of seriously-ill Veterans.