The Hemodialysis Opioid Prescription Effort Consortium

血液透析阿片类药物处方努力联盟

• 批准号: 9902068
• 负责人: GAVIN BART
• 金额: $ 264.79万
• 依托单位: HENNEPIN HEALTHCARE RESEARCH INSTITUTE
• 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/9902068
• 关键词: Accident and Emergency department; Address; Affect; Anxiety; Arthralgia; Behavioral; Bone Pain; Buprenorphine; Caring; Chronic; Cognitive; Comorbidity; Control Groups; Data; Dialysis patients; Dialysis procedure; Dose; Education; Effectiveness; Fracture; Hemodialysis; High Prevalence; Hospitalization; Individual; Intervention; Maintenance; Malignant neoplasm of liver; Medicare; Medication Management; Opioid; Opioid Analgesics; Opioid agonist; Pain; Pain management; Participant; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Population; Quality of life; Randomized; Reporting; Risk; Rotation; Secondary to; Severities; Surveys; Symptoms; Training; active method; adverse event risk; care coordination; chronic pain; chronic pain patient; chronic painful condition; depressive symptoms; experience; falls; functional status; health related quality of life; high risk; improved; intervention program; mental state; mortality; non-opioid analgesic; opioid epidemic; opioid therapy; opioid use; pain self-management; patient oriented; personalized care; prescription opioid; psychosocial; randomized trial; satisfaction; self-management program; successful intervention; treatment arm

PROJECT SUMMARY/ABSTRACT The opioid epidemic has not spared the hemodialysis population. Rates of chronic pain and opioid use are higher among patients treated with hemodialysis than in the general Medicare population and are comparable to rates for individuals with liver cancer. In a survey of symptoms among patients receiving hemodialysis, bone and joint pain was among the most prevalent (approximately 50%) and most bothersome symptoms reported. In addition, pain was associated with lower health-related quality of life and higher likelihood of depressive affect, abbreviated dialysis sessions, emergency department (ED) encounters, hospitalizations, and mortality. Recent studies using Medicare Part D prescription data found that over 60% of dialysis patients received at least one prescription for an opioid medication over the course of 1 year. Unfortunately, this widespread use of opioid medications is not benign; patients receiving opioids are at higher risk of hospitalization or ED encounters for altered mental status, falls, and fractures, and all-cause mortality. Despite the pervasive use of opioid analgesics in the dialysis population and the substantial risks they engender, their efficacy is limited in treating common chronic pain conditions, and most patients receiving long- term opioid therapy continue to experience severe pain and functional limitations. Furthermore, although studies in the general chronic pain population have identified successful interventions to manage pain and improve functional status, few studies have addressed this pressing problem in the dialysis population. Because patients receiving maintenance hemodialysis are encumbered by a unique combination of treatment burden, comorbid conditions, and psychosocial challenges, strategies that may be effective in non-dialysis populations may not provide benefit in the dialysis population. Further, given the diversity and complexity of challenges faced by patients with chronic pain receiving maintenance hemodialysis, individualized care approaches are likely to be especially important in this population. To simultaneously address problems related to chronic pain and opioid use in the U.S. hemodialysis population, we propose to evaluate tailored, patient-centered interventions to manage pain and reduce opioid use. Specifically, we propose to randomly assign patients in a 1:2:2 fashion to one of three groups over a 12- month study period: 1) pain care management (PCM), including collaborative opioid taper support, non-opioid medication management, and care coordination, versus 2) PCM plus an on-line pain self-management program (PSM) that incorporates cognitive behavioral training and is delivered during dialysis sessions, versus 3) control with medication review and education. We also propose to evaluate the effectiveness of offering buprenorphine. We will randomly assign participants in both active treatment arms to being offered buprenorphine rotation versus continued standard opioid taper support without the option of buprenorphine.

项目概要/摘要 阿片类药物的流行也未能幸免于血液透析人群。慢性疼痛和阿片类药物使用率 接受血液透析治疗的患者的患病率高于一般医疗保险人群，并且 与肝癌患者的发病率相当。在一项对接受治疗的患者的症状调查中 血液透析、骨关节疼痛是最常见（约 50%）和最令人烦恼的疼痛之一 报告的症状。此外，疼痛与较低的健康相关生活质量和较高的健康相关生活质量有关。 抑郁影响的可能性、缩短透析时间、急诊室 (ED) 遭遇、 住院率和死亡率。最近使用 Medicare D 部分处方数据进行的研究发现，超过 60% 透析患者在一年内至少接受过一张阿片类药物处方。 不幸的是，阿片类药物的广泛使用并不是良性的。接受阿片类药物治疗的患者比例较高 因精神状态改变、跌倒和骨折以及全因死亡而住院或急诊室的风险。 尽管阿片类镇痛药在透析人群中普遍使用且存在巨大风险 产生，它们在治疗常见慢性疼痛方面的功效有限，并且大多数患者接受长期治疗 长期阿片类药物治疗继续经历严重疼痛和功能限制。此外，虽然 对一般慢性疼痛人群的研究已经确定了控制疼痛和治疗的成功干预措施 改善功能状态，但很少有研究解决透析人群中的这一紧迫问题。 因为接受维持性血液透析的患者受到独特的治疗组合的阻碍 负担、合并症和社会心理挑战，在非透析中可能有效的策略 人群可能无法为透析人群提供益处。此外，考虑到事物的多样性和复杂性 接受维持性血液透析、个体化护理的慢性疼痛患者面临的挑战 方法对于这一人群可能特别重要。 同时解决美国血液透析中与慢性疼痛和阿片类药物使用相关的问题 针对人群，我们建议评估量身定制的、以患者为中心的干预措施，以控制疼痛和减少阿片类药物 使用。具体来说，我们建议以 1:2:2 的方式将患者随机分配到 12 组中的三组之一 月研究期：1) 疼痛护理管理 (PCM)，包括协作阿片类药物逐渐减量支持、非阿片类药物 药物管理和护理协调，对比 2) PCM 加上在线疼痛自我管理 计划（PSM）包含认知行为训练并在透析过程中进行，而不是 3）通过药物审查和教育进行控制。我们还建议评估产品的有效性 丁丙诺啡。我们将随机分配两个积极治疗组的参与者 丁丙诺啡轮换与持续标准阿片类药物逐渐减量支持（不选择丁丙诺啡）的比较。