Pain, Opioids, and ESRD risk reduction with Mindfulness and Buprenorphine (POEM-B): A 3-arm multi-site randomized trial in hemodialysis patients

正念和丁丙诺啡可降低疼痛、阿片类药物和 ESRD 风险 (POEM-B)：针对血液透析患者的 3 组多中心随机试验

• 批准号: 9901871
• 负责人: David M Charytan
• 金额: $ 288.33万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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/9901871
• 关键词: Address; Admission activity; Adult; Anxiety; Buprenorphine; Chronic; Clinical; Clinical Trials; Cognitive Therapy; Criminal Justice; Data; Dialysis patients; Dialysis procedure; Doctor of Philosophy; Effectiveness; End stage renal failure; Ethnic Origin; Expenditure; Fracture; Funding; Gender; Health; Hemodialysis; Hospital Mortality; Hospitalization; Inpatients; Intervention; Knowledge; Leadership; Maintenance; Measures; Medicare; Medicine; Mental Depression; Mindfulness Training; Modeling; Naltrexone; Narcotics; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Drug Abuse; National Institute on Alcohol Abuse and Alcoholism; Nephrology; New York; Opioid; Pain; Pain intensity; Pain interference; Pain management; Palliative Care; Patient Care; Patient Education; Patient Self-Report; Patient-Focused Outcomes; Patients; Pattern; Pharmacological Treatment; Pharmacotherapy; Physical Function; Physicians; Population; Practice Guidelines; Primary Health Care; Principal Investigator; Protocols documentation; Provider; Quality of life; Race; Randomized; Research; Research Personnel; Resources; Risk Reduction; Safety; Schools; Site; Social Functioning; Source; Suboxone; Telephone; Testing; Therapeutic Intervention; Time; United States; United States National Institutes of Health; Universities; Vulnerable Populations; Work; addiction; adverse outcome; arm; base; chronic pain; clinical care; clinically significant; collaborative care; collaborative trial; design; experience; high risk; high risk population; hospital admission rate; improved; medical schools; mental function; mental state; mindfulness; mindfulness based cognitive therapy; mindfulness intervention; mortality; mortality risk; non-opioid analgesic; novel; novel therapeutics; open label; opioid use; opioid use disorder; pain self-management; patient population; prescription opioid; preventable death; primary outcome; randomized trial; recruit; response; satisfaction; secondary endpoint; secondary outcome; treatment as usual; waiver

Abstract Despite the expenditure of nearly 6% of Medicare funds on the care of patients with end stage renal disease, quality of life is poor and chronic pain present in the majority of the 511,000 maintenance dialysis patients in the United States. Evidence to guide pain control and the safe use of opioid narcotics in this population is scant, but opioids are nevertheless utilized by the majority of maintenance dialysis patients and are associated with greatly elevated risks of death, hospitalizations, fractures, and mental status changes. In response to the NIDDK HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium (RFA-DK-18-030) and the clear need for data to better guide opioid use in hemodialysis patients, we propose the addition of New York University School (NYU) of Medicine as a HOPE consortium clinical center and the Pain and Opioids in End Stage Renal Disease risk reduction with Mindfulness and Buprenorphine (POEM-B) Trial: a 3-arm multi-site randomized trial. Approximately 600 hemodialysis patients receiving chronic opioids will be randomized across the HOPE consortium to enhanced treatment as usual, buprenorphine therapy, or buprenorphine plus mindfulness-based cognitive therapy intervention delivered by telephone and adapted for pain (MCBT-TP). The principal investigators and the co-Investigators at the NYU clinical center are deeply experienced in working with opioid patient populations and leading high-quality and collaborative NIH clinical trials in the hemodialysis population, mindfulness-based therapies, and opioid medication treatments. Furthermore, a local network including 20 free-standing dialysis units and more than 2900 dialysis patients will allow the NYU clinical center to recruit from a uniquely large source population representative of the diversity of race, ethnicity, gender and dialysis practice patterns across the United States. These investigators and resources will be leveraged to assess the following specific aims: Aim 1—To assess the effectiveness of buprenorphine in reducing chronic opioid use and prescriptions in hemodialysis patients on opioids at baseline, compared with an enhanced treatment as usual intervention and to assess the effectiveness buprenorphine in improving pain intensity, other quality of life measures, and hospitalizations; Aim 2—To assess the incremental effectiveness of a mindfulness-based cognitive therapy intervention delivered by telephone and adapted for pain (MBCT-TP) added to buprenorphine compared to buprenorphine alone on pain-interference with physical, social, and mental functioning, opioid use, pain intensity, other quality of life measures, hospitalizations, and mortality. The POEM-B study addresses a critical knowledge gap and will provide evidence that can be readily implemented into clinical care and that directly improves quality of life and patient-centered outcomes in a growing and high-risk population.

抽象的 尽管近6％的医疗保险基金在终末期肾脏疾病患者的护理方面支出，但 在511,000名维持透析患者中​​，大多数人的生活质量较差，慢性疼痛 美国。指导疼痛控制和在该人群中安全使用阿片类药物的证据很少，但是 然而，大多数维持透析患者都使用阿片类药物，并且与 死亡，住院，骨折和心理状况的变化升高。响应尼德克治愈 倡议：血液透析患者疼痛和阿片类药物使用的综合方法：血液透析阿片类药物 处方工作（希望）财团（RFA-DK-18-030）和清楚的数据需要更好地指导阿片类药物的使用 在血液透析患者中​​，我们建议增加纽约大学学校（NYU）的医学 财团临床中心以及末期肾脏疾病风险降低正念的疼痛和阿片类药物 和丁丙诺啡（Poem-B）试验：3臂多站点随机试验。大约600个血液透析 接受慢性阿片类药物的患者将在整个希望财团中随机分配，以增强治疗 通常，丁丙诺啡治疗或丁丙诺啡以及基于正念的认知疗法干预 通过电话并适应疼痛（MCBT-TP）。纽约大学的主要研究人员和共同研究人员 临床中心在与阿片类药物患者人群和领先的高质量和高质量和 血液透析人群，基于正念的疗法和OOID的合作NIH临床试验 药物治疗。此外，一个本地网络，包括20个独立透析单元，超过 2900名透析患者将允许NYU临床中心从独特的源人群中招募 代表美国各地种族，种族，性别和透析实践模式的多样性。 这些调查人员和资源将被利用以评估以下特定目的：目标1-评估 丁丙诺啡在减少慢性阿片类药物使用和血液透析患者处方的有效性 基线时的烯型蛋白类药物，与往常一样增强治疗并评估有效性 丁丙诺啡在改善疼痛强度，其他生活质量措施和住院治疗方面；目标2 - 评估 通过电话和 与单独的抑制剂相比，适应疼痛（MBCT-TP）在丁丙诺啡中添加到疼痛中吗啡 随着身体，社交和心理功能，阿片类药物的使用，疼痛强度，其他生活质量测量， 住院和死亡率。这首诗-B的研究解决了关键的知识差距，并将提供证据 可以很容易地将其实施到临床护理中，并直接改善生活质量和以患者为中心 人口增长和高风险的结果。