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

背景：在过去的十年中，VA实施了阿片类药物政策，最值得注意的是2013年阿片类药物安全性 该倡议旨在解决迅速发展的阿片类药物危机。随着钟摆从阿片类药物转向 开处方时，一些患有严重疾病的患者可能会发生意外 后果，包括不受控制的疼痛，即使其他人可能避免了潜在的并发症， 阿片类药物使用该项目研究了这些政策对终末期肾病退伍军人的潜在影响。 疾病（ESRD），大约35，000退伍军人的人口，他们平衡的好处和危害 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， 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 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。与其他相比， 严重疾病的人群，他们有更少的非阿片类镇痛药的替代品可以依靠，并可能面临 非药物疼痛管理策略的障碍。此外，大多数ESRD退伍军人接受 在VA社区护理或医疗保险下的社区透析，使他们暴露于潜在的 护理碎片化对阿片类药物安全性和疼痛控制的不利影响。 意义/影响：了解VA举措对改善人群阿片类药物安全性的影响 对患有严重疾病的退伍军人的水平是至关重要的VA的承诺，以确保这些脆弱的 退伍军人得到了缓解痛苦症状的护理。这里提出的工作是响应 VA卫生部副部长的优先事项是改善疼痛管理和止痛药的安全性。 创新：这项拟议的研究是第一个研究阿片类药物安全措施和处方的影响的研究。 对一群重病退伍军人的指导方针。它利用VA数据，包括丰富的疼痛控制措施 从任何其他国家数据来源无法获得。使用序贯解释性混合方法研究 设计三角形定量和定性研究结果疼痛管理的背景下，当代 阿片类药物政策是对阿片类药物研究领域的新贡献。 具体目的：1）检查疼痛管理策略、阿片类药物相关SAE和疼痛控制的变化 2010-2018年ESRD退伍军人中; 2）按透析设置比较阿片类药物相关SAE的变化 (VA，VA-社区护理，医疗保险）从2010年至2018年; 3）引出退伍军人的观点和经验 在VA阿片类药物安全性的背景下，ESRD患者和护理他们的临床医生与疼痛管理相关 为政策和实践提供信息。 方法：本研究采用序贯解释性混合方法设计。的定量部分 该研究（目标1和2）包括2010年至2018年期间所有VA中接受透析的退伍军人。我们将 对关联的VA、Medicare和USRDS数据进行中断时间序列分析，以检查是否 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），阿片类药物- 自2013年OSI以来，总体和按透析设置列出的相关严重不良反应和疼痛。然后我们将 与ESRD退伍军人和照顾ESRD患者的VA临床医生进行半结构化访谈， 确定VA疼痛管理政策和实践的改进机会（目标3）。 实施/后续步骤：我们将与业务合作伙伴咨询委员会合作，确保我们的 研究将为政策提供有关如何最佳调整阿片类药物安全措施和疼痛管理的信息 指导方针，以满足退伍军人与ESRD和那些与其他严重疾病的需要。我们将合作 与董事会一起制定一个“路线图”，总结我们的主要发现，确定对政策的影响， 临床护理，并确定未来临床和政策干预的优先事项，旨在优化疼痛控制， 患有ESRD的退伍军人。这一路线图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.