University of Illinois at Chicago Hemodialysis Opioid Prescription Effort (HOPE) Clinical Center

项目总结/摘要 接受长期血液透析（HD）的终末期肾病患者受以下因素的影响不成比例： 阿片类药物的流行多达三分之二的HD患者接受阿片类药物治疗，比一般患者高出三倍。 人口此外，在这一人群中使用阿片类药物与无数不良后果有关 包括增加福尔斯跌倒、认知受损、住院和死亡的风险。为了解决这个问题， 至关重要的是要认识到，超过一半的HD患者在治疗过程中会出现中度至重度疼痛， 这些患者的疼痛控制并不令人满意。此外，缺乏严格的 存在减少阿片类药物依赖的证据，并指导HD患者慢性疼痛的管理。 尽管已发现丁丙诺啡在一般情况下有效减少阿片类药物依赖， 人群中，尚未在HD患者中进行系统评价。此外，疼痛管理研究 HD患者主要关注药物治疗，报告的结果不一致。但 考虑到相当大的风险，迫切需要优先考虑这一人群的非药物治疗。 这些患者的药物负担以及许多镇痛药的治疗窗较窄。的目的 本研究旨在评估减少HD患者阿片类药物使用和疼痛的新策略。具体来说，我们将 检查非药物（接受和承诺疗法[ACT]和针灸）的效果， 接受慢性阿片类药物治疗的HD患者中的药物（丁丙诺啡）干预（>90 天/年），由于慢性疼痛和/或高疼痛干扰（>3个月持续时间）。本研究将入组720例HD 5家美国血液透析阿片类药物处方努力联盟临床中心的患者。我们建议使用 定量序贯多重分配随机试验（SMART）设计，增加了定性 执行研究部分，以便我们能够评估适应性干预措施，同时应对 患者的特征。本研究的具体目的是：（1）确定ACT的有效性， 与对照组相比，针刺在减少阿片类药物剂量和改善HD患者疼痛方面的作用 患者;（2）确定改善结果的最佳适应性干预序列;（3）探索年龄，性别， 合并症作为干预反应的潜在调节因素;（4）描述促进因素， 使用深入的，半结构化的个人访谈， 干预参与者和提供者。拟议的研究具有减少阿片类药物使用的强大潜力， 改善HD人群的疼痛管理。该建议的优点包括：a）创新研究 设计; B）多学科团队带来了肾脏疾病，疼痛管理， 成瘾精神病学和实施科学; c）建立合作伙伴关系，促进获得 对大量慢性阿片类药物使用率高的HD患者，以及d）研究小组的 在NIH赞助的大型项目中招募和保留肾病患者方面有着良好的记录。

Project Summary/Abstract Patients with end stage renal disease receiving chronic hemodialysis (HD) are disproportionately affected by the opioid epidemic. Up to two-thirds of HD patients receive opioids, three-fold higher than the general population. Moreover, opioid use in this population has been associated with a myriad of adverse outcomes including increased risk of falls, impaired cognition, hospitalization and death. To address this problem, it is of critical importance to recognize that more than one-half of HD patients experience moderate to severe pain on a regular basis, and pain control among these patients is unsatisfactory. Furthermore, a lack of rigorous evidence exists to reduce opioid dependence, and to guide management of chronic pain among HD patients. Although buprenorphine has been found to be effective in reducing opioid dependence in the general population, it has not been systematically evaluated in HD patients. Furthermore, pain management studies in HD patients have largely focused on pharmacologic therapies, reporting inconsistent findings. However, there is an urgent need to prioritize non-pharmacologic treatments for this population in view of the considerable medication burden in these patients and the narrower therapeutic window of many analgesics. The purpose of this study is to evaluate novel strategies to reduce opioid use and pain in HD patients. Specifically, we will examine the effect of non-pharmacologic (Acceptance and Commitment Therapy [ACT] and acupuncture) and pharmacologic (buprenorphine) interventions in HD patients who are receiving chronic opioid medications (>90 days/year) due to chronic pain and/or high pain interference (>3 months duration). The study will enroll 720 HD patients across 5 U.S. Hemodialysis Opioid Prescription Effort Consortium Clinical Centers. We propose to use a quantitative Sequential Multiple Assignment Randomized Trial (SMART) design with an added qualitative implementation research component so that we can evaluate adaptive interventions while responding to patients’ characteristics. The specific aims of this study are to: (1) Determine the effectiveness of ACT and acupuncture as compared to the control condition in reducing opioid dose and improving pain among HD patients; (2) Identify the best adaptive intervention sequence for improved outcomes; (3) Explore age, sex, and comorbidities as potential moderators of the response to the intervention; and (4) Describe facilitators and barriers to the implementation of the intervention using in-depth, semi-structured individual interviews with intervention participants and providers. The proposed study has a strong potential for reducing opioid use and improving pain management in the HD population. Strengths of this proposal include: a) the innovative study design; b) the multidisciplinary team bringing considerable expertise in kidney disease, pain management, addiction psychiatry, and implementation science; c) established collaborative partnerships facilitating access to a large population of HD patients with a high prevalence of chronic opioid use, and d) the research team’s strong track record in recruitment and retention of kidney disease patients in large NIH-sponsored initiatives.