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

单独 CBT 与丁丙诺啡比较的随机 ESRD 试验（恢复）

• 批准号: 10614763
• 负责人: Daniel Cukor
• 金额: $ 62.14万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10614763
• 关键词: Academic Medical Centers; Acute; Affect; American; American Indians; Area; Black race; Buprenorphine; Clinical Trials; Clinical Trials Design; Communities; Coping Skills; Data; Diabetes Mellitus; Dose; Educational Intervention; Educational Materials; Elderly; Elements; End stage renal failure; Enrollment; Ensure; Fracture; Frequencies; Funding; General Population; Generations; Geography; Goals; Heart failure; Helping to End Addiction Long-term; Hemodialysis; High Prevalence; Hospitalization; Individual; Infrastructure; Intervention; Kidney; Kidney Failure; Latino; Maintenance; Motivation; Multicenter Trials; Musculoskeletal; Neuropathy; New Mexico; New York; Opioid; Pacific Northwest; Pain; Pain interference; Participant; Patients; Persons; Population; Population Heterogeneity; Positioning Attribute; Randomized; Randomized Controlled Clinical Trials; Readiness; Reporting; Research; Research Personnel; Risk; Rural Community; Safety; Site; Subgroup; Symptoms; Tablets; Technology; Testing; Time; Travel; Universities; Validity of Results; Visual; Washington; Work; adverse event risk; chronic pain; chronic pain management; chronic pain patient; clinical center; cultural competence; design; digital; digital health; digital intervention; disability; effective therapy; efficacy testing; ethnic minority; falls; health literacy; high risk; improved; low socioeconomic status; mHealth; metropolitan; mortality; opioid epidemic; outreach; pain reduction; participant enrollment; patient engagement; physically handicapped; prescription opioid; racial and ethnic; racial minority; recruit; remote communities; rural area; skills training; telehealth; trial comparing; trial design; urban area

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.

项目概要/摘要 超过 60% 接受长期血液透析治疗的肾衰竭患者报告因高度疲劳而出现慢性疼痛 普遍的肌肉骨骼和神经病变。迄今为止还没有临床试验测试其功效和作用 控制该人群慢性疼痛的治疗方法的安全性。因此，阿片类药物的处方率 尽管接受维持性血液透析的人数比一般人群高出 2-4 倍 不良事件的风险显着更高。 HEAL 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功效的试验 为接受长期血液透析的患者开药。 HOPE 试验计划招募 640 名参与者 来自由 16 个招募点组成的 8 个临床中心；迄今为止，已有 327 名参与者报名。这 联盟从一开始就成功地吸引了患者，这有助于招募高比例的患者 黑人和拉丁裔参与者。但在招收几个关键群体方面仍存在重大差距。审判正在交付 通过远程医疗进行 PCST 干预；许多患者的动机准备度和技术熟练程度较低 都构成入学障碍。肾衰竭对老年人和患有糖尿病的人影响尤为严重 身体和视力残疾、对移动健康犹豫不决和研究参与度较低的亚群体。 目前的试验基础设施也不允许我们接触美洲印第安人和农村人口 肾衰竭和阿片类药物处方患病率较高的社区、亚群体。弥合这些差距 并确保外部有效的推论，华盛顿大学临床中心（位于新墨西哥州阿尔伯克基， 纽约州纽约市和华盛顿州西雅图市）、科学数据和研究中心 (SDRC) 以及 HOPE 试验患者 咨询小组正在请求补充资金，以提高三个亚组个人的入学率 - (1) 对移动健康犹豫不决的人； (2) 居住在新阿尔伯克基附近农村社区的美洲印第安人 墨西哥; (3) 西雅图附近基萨普半岛和奥林匹克半岛上地理上孤立的社区。 拟议的战略是对 NOSI 的回应，因为我们计划 (1) 制定促进包容性的战略 HOPE 是一项使用数字干预的研究； (2) 开发和传播（数字化）学习材料 适当的健康素养； (3) 拥有具有文化能力的患者协调员，以促进外展活动 美洲印第安人的入学； (4) 为不同旅行的患者提供外展服务并为其提供住宿 诸如偏远社区的需求。重要的是，拟议的工作将实现其目标，而无需 增加初学的负担。 SDRC 将分发教育材料以克服 移动健康对所有 16 个注册网站都犹豫不决。对美洲印第安人社区的外展工作和 基萨普和奥林匹克半岛将使威斯康星大学临床中心能够超越其当前的招生目标 这将有助于弥补其他中心的入学不足。总的来说，这些努力将进一步增强患者 参与并允许试验招募更多样化的参与者群体，以获得更大的外部有效性。