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

伊利诺伊大学芝加哥分校血液透析阿片类处方药物 (HOPE) 临床中心

• 批准号: 9900385
• 负责人: Ardith Z Doorenbos
• 金额: $ 284.54万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-24 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9900385
• 关键词: Acupuncture Therapy; Address; Affect; Age; Analgesics; Buprenorphine; Cessation of life; Characteristics; Chicago; Chronic; Clinical; Comorbidity; Country; Data Collection; Dialysis patients; Discipline of Nursing; Dose; Effectiveness; End stage renal failure; Enrollment; General Population; Health; Hemodialysis; High Prevalence; Hospitalization; Hybrids; Illinois; Impaired cognition; Individual; Intervention; Interview; Kidney Diseases; Needles; Nephrology; Opiate Addiction; Opioid; Outcome; Overdose; Pain; Pain interference; Pain management; Patients; Pharmaceutical Preparations; Pharmacology; Population; Population Intervention; Practice Management; Provider; Psychiatry; Quality of life; Randomized; Reporting; Research; Research Design; Severities; Structure; Therapeutic; Therapeutic Intervention; Time; Translating; United States; United States National Institutes of Health; Universities; adaptive intervention; addiction; adverse outcome; anxiety symptoms; base; chronic pain; depressive symptoms; design; effective therapy; effectiveness trial; experience; fall risk; implementation research; implementation science; improved; improved outcome; innovation; intervention participants; multidisciplinary; novel strategies; opioid epidemic; opioid use; pain reduction; pain relief; pain symptom; prescription opioid; randomized trial; recruit; response; secondary outcome; sex; treatment strategy; trial design

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.

项目概要/摘要 接受慢性血液透析 (HD) 的终末期肾病患者受到以下因素的影响尤为严重： 阿片类药物流行。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。 此外，该人群中阿片类药物的使用与多种不良后果有关。 包括增加跌倒、认知受损、住院和死亡的风险。 认识到超过一半的 HD 患者在日常生活中经历中度至重度疼痛至关重要 定期进行治疗，这些患者的疼痛控制并不令人满意，而且缺乏严格的控制。 现有证据可以减少阿片类药物依赖，并指导 HD 患者慢性疼痛的治疗。 尽管丁丙诺啡已被发现可有效减少一般情况下的阿片类药物依赖 此外，尚未对 HD 患者的疼痛管理研究进行系统评估。 HD 患者主要关注药物治疗，但报告结果不一致。 鉴于相当多的患者，迫切需要优先考虑对这一人群进行非药物治疗 这些患者的药物负担和许多镇痛药治疗窗口缩小的目的。 这项研究旨在评估减少 HD 患者阿片类药物使用和疼痛的新策略。 检查非药物疗法（接受与承诺疗法 [ACT] 和针灸）的效果 对正在接受长期阿片类药物治疗的 HD 患者进行药物（丁丙诺啡）干预（>90 天/年）由于慢性疼痛和/或高度疼痛干扰（>3 个月持续时间） 该研究将招募 720 名 HD。 我们建议使用 5 个美国血液透析阿片类药物处方努力联盟临床中心的患者。 序贯定量多重分配随机试验 (SMART) 设计，并添加定性 实施研究部分，以便我们可以在响应的同时评估适应性干预措施 本研究的具体目的是： (1) 确定 ACT 的有效性和 与对照条件相比，针刺在减少 HD 患者阿片类药物剂量和改善疼痛方面的作用 (2) 确定改善结果的最佳适应性干预序列； (3) 探索年龄、性别和 合并症是干预反应的潜在调节因素；(4) 描述促进因素； 通过深入、半结构化的个人访谈来了解实施干预措施的障碍 拟议的研究具有减少阿片类药物使用和干预的巨大潜力。 该提案的优点包括：a) 创新研究。 设计；b) 多学科团队在肾脏疾病、疼痛管理、 c) 建立促进获取的合作伙伴关系 大量慢性阿片类药物使用率很高的 HD 患者，以及 d) 研究小组的 在 NIH 资助的大型计划中招募和保留肾病患者方面有着良好的记录。