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 倡议，旨在解决Brgeoning阿片类药物危机。随着钟摆远离阿片类药物 开处方，有些患有严重疾病的患者可能会经历意外 后果，包括不受控制的疼痛，即使其他人也可能避免了潜在的并发症 Opioid使用。该项目研究了这些政策对具有终端肾脏的退伍军人的潜在影响 疾病（ESRD），大约有35,000名退伍军人的人口平衡 阿片类药物可能特别挑战。这些退伍军人的预期寿命非常有限，很大 疼痛伯嫩，与转移性癌症的退伍军人相当，但经常被低估。他们在 阿片类药物相关的严重不良事件的风险增加（SAE；例如阿片类药物过量）。与其他 认真地说，他们的非阿片类镇痛替代品很少可以倒退，可能会面对 非药物疼痛管理策略的障碍。而且，大多数ESRD的退伍军人都接受 在VA社区护理或Medicare下，社区中的透析，将其暴露于潜力 护理破碎对阿片类药物安全和疼痛控制的不利影响。 意义/影响：了解VA计划改善阿片类药物安全的影响 对患有严重疾病的退伍军人的水平对于VA的承诺至关重要 提供了退伍军人的护理，以挽救令人痛苦的症状。这里提出的工作对 弗吉尼亚州的卫生秘书是改善疼痛管理和止痛药安全性的优先事项。 创新：拟议的研究是第一个研究阿片类药物安全计划和处方的影响 一群认真的退伍军人指南。它利用VA数据，其中包括丰富的疼痛控制度量 任何其他国家数据源都无法获得。使用顺序挖掘的混合方法研究 在当代的背景下进行三角测量的定量和定性发现 阿片类药物政策是对阿片类药物研究领域的新颖贡献。 具体目的：1）检查疼痛管理策略的变化，与阿片类药物相关的SAE和疼痛控制 在2010年至2018年的ESRD的退伍军人中； 2）通过设置透析来比较阿片类药物相关的SAE的变化 （VA，VA-Community Care，Medicare）2010- 2018年； 3）引起退伍军人的观点和经验 在VA阿片类药物安全的背景下，ESRD和关心与疼痛管理有关的临床医生 为了告知政策和实践的举措。 方法论：研究员工是顺序利用混合方法设计。定量部分 这项研究（目标1和2）包括2010年至2018年间所有VAS的透析的退伍军人。我们将 对链接的VA，Medicare和USRDS数据进行中断的时间序列分析，以检查是否是否检查 ESRD的退伍军人在疼痛疗法（阿片类药物，非阿片类药物，非药物），阿片类药物的疼痛疗法上有变化 自2013年OSI以来，随着时间的推移，相关的严重不利和疼痛，整体和通过透析的设置。然后我们会 与ESRD和VA临床医生对退伍军人进行半结构化访谈，他们关心ESRD患者 确定改善VA疼痛管理政策和实践的机会（AIM 3）。 实施/下一步：我们将与我们的顾问委员会合作，以确保我们的 研究将向政策提供有关如何最佳调整Ooid安全计划和疼痛管理的信息 满足ESRD和其他严重疾病的退伍军人需求的准则。我们将合作 董事会开发一个“路线图”，将总结我们的关键发现，确定对政策的影响和 临床护理，并确定未来的临床和政策干预措施的优先级，旨在优化疼痛控制 ESRD的退伍军人。该路线图可能会适用于其他认真的老兵团体。