Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER)

项目摘要/摘要 超过60%的接受长期血液透析治疗的肾衰竭患者报告说，慢性疼痛来自于高度 普遍存在的肌肉骨骼和神经性疾病。到目前为止，还没有临床试验测试过这种药物的疗效 在这一人群中管理慢性疼痛的治疗的安全性。因此，阿片类药物处方的比率 接受维持性血液透析的人数是普通人群的2-4倍，尽管 发生不良事件的风险显著增加。Hear Initiative HOPE试验是一项随机对照临床试验 旨在测试疼痛应对技能训练(PCST)减少疼痛干扰和阿片类药物的有效性的试验 长期血液透析患者的处方。HOPE试验试图招募640名参与者 来自8个临床中心，由16个注册站点组成；到目前为止，已有327名参与者注册。这个 该联盟从一开始就成功地吸引了患者，这帮助招募了很高比例的 黑人和拉丁裔参与者。但在招收几个关键子群体方面，仍然存在重大差距。这项试验正在奏效 通过远程医疗进行PCST干预；许多患者的动机准备和技术熟练程度较低 假装是招生的障碍。肾衰竭对老年人和患有肾衰竭的人的影响不成比例 身体和视觉障碍，具有高度移动健康犹豫不决和较低研究参与率的亚组。 目前的试验基础设施也不允许我们接触到美国印第安人和农村人口 肾功能衰竭和阿片类药物处方高发的社区、亚组。为了弥合这些差距 并确保外部有效的推断，华盛顿大学临床中心(位于新墨西哥州阿尔伯克基的网站， 纽约和华盛顿州西雅图)、科学数据和研究中心(SDRC)以及HOPE试验患者 咨询小组正在申请补充资金，以增加三个分组的个人的登记人数- (1)那些行动不便的人；(2)生活在纽约州阿尔伯克基附近农村社区的美国印第安人 墨西哥；以及(3)西雅图附近基特萨普半岛和奥利普姆半岛上地理上与世隔绝的社区。 由于我们计划(1)制定促进包容性的战略，因此建议的战略是响应国家战略倡议。 希望是一项使用数字干预的研究；(2)开发和传播(数字)学习材料 适当的健康素养；(3)拥有有文化能力的患者协调员，以促进接触和 招收美国印第安人；以及(4)为不同旅行的患者提供外展服务和住宿 例如偏远社区的需求。重要的是，拟议的工作将在没有 增加了初级学习的负担。国家发改委将发放教育材料，以克服 移动健康对所有16个注册站点犹豫不决。对美国印第安人社区的外展努力和 Kitsap和奥林匹克半岛计划将使华盛顿大学临床中心超过目前的招生目标，并 这将有助于弥补其他中心的入学人数不足。总体而言，这些努力将进一步提高患者的耐心 并允许试验招募更多样化的参与者，以获得更大的外部有效性。

PROJECT SUMMARY/ABSTRACT Over 60% of patients with kidney failure treated with long-term hemodialysis report chronic pain from highly prevalent musculoskeletal and neuropathic conditions. No clinical trial thus far has tested the efficacy and safety of treatments to manage chronic pain in this population. As such, the rate of opioid prescribing for people undergoing maintenance hemodialysis is 2-4 times higher than for the general population despite the significahtly higher risk for adverse events. The HEAL Initiative HOPE trial is a randomized controlled clinical trial designed to test the efficacy of pain coping skills training (PCST) to reduce pain interference and opioid prescribing for patients undergoing long-term hemodialysis. The HOPE trial seeks to enroll 640 participants from eight Clinical Centers composed of 16 enrolling sites; 327 participants have been enrolled to date. The consortium has successfully engaged patients from the outset and this has helped enroll a high proportion of Black and Latino participants. But major gaps remain in enrolling several key sub-groups. The trial is delivering the PCST intervention via telehealth; low motivational readiness and technology proficiency in many patients are posing as barriers to enrollment. Kidney failure disproportionately affects the elderly and those with physical and visual disabilities, sub-groups with high mobile health hesitancy and lower research participation. The current trial infrastructure also does not allow us to reach out to American Indian populations and rural communities, sub-groups with high prevalence of kidney failure and opioid prescribing. To bridge these gaps and ensure externally valid inferences, the University of Washington Clinical Center (sites in Albuquerque, NM, New York, NY, and Seattle, WA), the Scientific Data and Research Center (SDRC), and HOPE Trial Patient Advisory Group are requesting supplemental funds to enhance enrollment of three sub-groups of individuals – (1) those with mobile health hesitancy; (2) American Indians living in rural communities near Albuquerque, New Mexico; and (3) the geographically isolated community on the Kitsap and Olypmic Peninsulas near Seattle. The proposed strategies are responsive to the NOSI as we plan to (1) develop strategies to promote inclusion in HOPE, a study using digital interventions; (2) develop and disseminate study materials that are (digital) health literacy appropriate; (3) have culturally competent patient coordinators to facilitate outreach to and enrollment of American Indians; and (4) provide outreach to and accommodate patients with diverse travel needs such as those in remote communities. Importantly, the proposed work will accomplish its goals without increasing burden to the primary study. The SDRC will disseminate the educational materials to overcome mobile health hesitancy to all the 16 enrolling sites. The outreach efforts to American Indian communities and the Kitsap and Olympic Peninsulas will allow the UW Clinical Center to exceed its current enrollmet targets and this will help offset enrollment shortfalls at other Centers. Collectively, these efforts will further enhance patient engagement and allow the trial to enroll a more diverse population of participants for greater external validity.