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.

项目总结/摘要 超过60%的接受长期血液透析治疗的肾衰竭患者报告了高度慢性疼痛。 普遍的肌肉骨骼和神经病变。到目前为止，还没有临床试验测试过这种药物的疗效， 治疗慢性疼痛的安全性。因此，阿片类药物处方率 接受维持性血液透析的人比一般人群高2-4倍， 发生不良事件的风险明显更高。HEAL Initiative HOPE试验是一项随机对照临床试验， 一项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疗效的试验 为长期血液透析患者开处方。HOPE试验旨在招募640名参与者 来自由16个入组研究中心组成的8个临床中心;迄今为止已入组327名受试者。的 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 黑人和拉丁裔参与者。但在招收几个关键的次级群体方面仍然存在重大差距。审判正在进行 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 成为入学的障碍肾衰竭不成比例地影响老年人和那些 身体和视力残疾者、对移动的健康问题犹豫不决和参与研究较少的亚群体。 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。 社区、肾衰竭和阿片类药物处方高发的亚组。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（位于阿尔伯克基，NM， 纽约和西雅图，华盛顿州）、科学数据和研究中心（SDRC）和HOPE试验患者 咨询小组要求补充资金，以提高三个小组的个人登记- (1)那些有移动的健康犹豫的人;（2）生活在阿尔伯克基，新 墨西哥;（3）地理上孤立的社区，在基萨普和奥林普米克半岛附近的西雅图。 建议的策略是回应NOSI，因为我们计划（1）制定促进包容的策略 在HOPE中，使用数字干预措施的研究;（2）开发和传播（数字） 适当的卫生知识;（3）有文化能力的病人协调员，以促进外联， 招募美国印第安人;（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，拟议的工作将实现其目标， 增加了主要研究的负担。发改中心会派发教育材料， 所有16个入组研究中心的移动的健康犹豫。对美洲印第安人社区的外联工作， Kitsap和奥林匹克半岛将使华盛顿大学临床中心超过其目前的招生目标， 这将有助于弥补其他中心的招生不足。总的来说，这些努力将进一步提高患者的 参与，并允许试验招募更多样化的参与者人群，以获得更大的外部效度。