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

优化退伍军人终末期肾病的疼痛管理 (OPERA-Vets)：平衡阿片类药物的利弊

• 批准号: 10668961
• 负责人: MELISSA WACHTERMAN
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10668961
• 关键词: Address; Adverse effects; Adverse event; Affect; Analgesics; Area; Back; Caring; Clinical; Collaborations; Communities; Community Healthcare; Complex; Data; Data Sources; Delirium; Development; Dialysis procedure; Disseminated Malignant Neoplasm; Distress; End stage renal failure; Ethics; Face; Frequencies; Future; Goals; Guidelines; Health Priorities; Healthcare; Interruption; Intervention; Interview; Kidney; Life Expectancy; Link; Measures; Medicare; Methodology; Methods; Nonpharmacologic Therapy; Opioid; Outcome; Overdose; Pain; Pain management; Pain quality; Palliative Care; Patients; Pharmaceutical Preparations; Policies; Population; Practice Guidelines; Practice Management; Public Health; Recommendation; Research; Research Design; Risk; Risk Reduction; Safety; Series; Serious Adverse Event; Structure; Symptoms; Testing; Time; Time Series Analysis; Veterans; Vulnerable Populations; Work; advanced disease; care fragmentation; clinical care; design; experience; falls; high risk population; implementation strategy; improved; innovation; insight; member; military veteran; non-opioid analgesic; novel; opioid epidemic; opioid misuse; opioid overdose; opioid policy; opioid use; pharmacy benefit; policy implication; prescription opioid; programs; trend; uptake

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.

背景：在过去的十年中，VA 实施了阿片类药物政策，最著名的是 2013 年阿片类药物安全 该倡议旨在解决日益严重的阿片类药物危机。随着钟摆已经远离阿片类药物 处方时，一些病情严重的患者可能会出现意想不到的情况 后果，包括不受控制的疼痛，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。该项目研究了这些政策对患有终末期肾病的退伍军人的潜在影响 疾病（ESRD），大约有 35,000 名退伍军人，对他们来说，要权衡以下疾病的益处和危害： 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，而且 疼痛负担，与患有转移性癌症的退伍军人相当，但常常被低估。他们在 与阿片类药物相关的严重不良事件（SAE；例如阿片类药物过量）的风险增加。但与其他相比 对于患有重病的人群，他们可以依靠的非阿片类镇痛药物较少，并且可能面临 非药物疼痛管理策略的障碍。此外，大多数患有 ESRD 的退伍军人都接受 根据 VA 社区护理或医疗保险在社区进行透析，使他们面临潜在的风险 护理碎片化对阿片类药物的安全性和疼痛控制产生不利影响。 意义/影响：了解 VA 举措对提高人群阿片类药物安全性的影响 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 为退伍军人提供缓解痛苦症状的护理。这里提出的工作是响应 退伍军人管理局卫生部副部长的首要任务是改善疼痛管理和止痛药物的安全性。 创新：拟议的研究是第一个检查阿片类药物安全举措和处方影响的研究 针对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 无法从任何其他国家数据源获得。使用序贯解释性混合方法研究 旨在对当代背景下疼痛管理的定量和定性发现进行三角测量 阿片类药物政策是对阿片类药物研究领域的一项新颖贡献。 具体目标：1) 检查疼痛管理策略、阿片类药物相关的 SAE 和疼痛控制方面的变化 2010 年至 2018 年患有 ESRD 的退伍军人中； 2) 通过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）2010 年至 2018 年； 3）征求退伍军人的观点和经验 与 ESRD 以及护理他们的临床医生在 VA 阿片类药物安全性的背景下进行疼痛管理相关的工作 旨在为政策和实践提供信息的举措。 方法：该研究采用序贯解释性混合方法设计。的数量部分 该研究（目标 1 和 2）包括 2010 年至 2018 年间所有退伍军人管理局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，随着时间的推移，总体上以及透析设置相关的严重不良反应和疼痛。我们随后将 对患有 ESRD 的退伍军人和照顾 ESRD 患者的 VA 临床医生进行半结构化访谈 确定改进 VA 疼痛管理政策和实践的机会（目标 3）。 实施/后续步骤：我们将与我们的运营合作伙伴顾问委员会合作，以确保我们的 研究将为有关如何最佳地协调阿片类药物安全举措和疼痛管理的政策提供信息 满足患有 ESRD 和患有其他严重疾病的退伍军人的需求的指南。我们将合作 与董事会一起制定“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。该路线图很可能适用于其他重病退伍军人群体。