Pain Reduction and Opioid MedIcation Safety in ESRD (PROMISE) study

摘要 超过一半的终末期肾病(ESRD)患者接受血液透析(HD) 与健康相关的生活质量差有关的衰弱疼痛增加 住院和死亡率。通常，他们的痛苦管理不善，效率低下。另外 这些患者中阿片类药物的高使用率增加了他们住院和 死亡率。年拟议的止痛和阿片类药物安全的总体目标 ESRD(Promise)研究旨在提高HD患者阿片类药物使用和疼痛控制的安全性 使用I型有效性-实施混合设计的患者。在这个多点随机的 血液透析阿片类药物处方(HOPE)对560例HD患者的对照试验 ，我们将使用2x2析因设计来检验两个独立的9- 月循证干预：1)阿片类药物缩减管理(OTM)，2) 行为疼痛管理(BPM)。OTM干预由协作性护理组成 护士护理经理与病人、初级保健医生密切合作的模式 (PCP)和透析团队开发和管理个性化的止痛药方法 优化，重点是阿片类药物逐渐减少或在所有患者术后过渡到丁丙诺啡 与患者和初级保健医生达成一致意见。BPM结合了两个基于证据的 治疗-接受和承诺疗法(ACT)治疗疼痛和认知行为 治疗(CBT)同时存在的抑郁/焦虑(如果存在)，并通过 高清期间的远程医疗。未分配给OTM或BPM的控制条件将是常见的 护理，并有权在12个月结束时接受ACT。我们将研究 OTM(与无OTM，目标1)和BPM(与无BPM，目标2)在9个月内的有效性 减少阿片类药物的使用(主要结果)和改善疼痛严重程度(次要结果) 慢性阿片类药物治疗的HD患者。实施目标将利用多样化的 患者、提供者和组织设置希望联合体评估过程 多个利益攸关方的成果(目标3)。我们的研究结合了新的工具和 用于减少阿片类药物相关发病率、解决阿片类药物流行、减轻 HD患者，除了提供洞察力以告知将这些干预措施整合到 透析实践和政策。

Abstract More than half of end-stage renal disease (ESRD) patients on hemodialysis (HD) report debilitating pain, which is associated with poor health-related quality of life, increased hospitalizations and mortality. Often, their pain is managed poorly and ineffectively. Additionally the high prevalence of opioid use in these patients increases their risk of hospitalizations and mortality. The overall goal of the proposed Pain Reduction and Opioid Medication Safety in ESRD (PROMISE) study is to improve safety of opioid use and pain management in HD patients using a Type I effectiveness-implementation hybrid design. In this multi-site randomized controlled trial of 560 HD patients from the Hemodialysis Opioid Prescription Effort (HOPE) Consortium, we will use a 2x2 factorial design to examine the effectiveness of two separate 9- month evidence-based interventions: 1) Opioid Tapering Management (OTM), and 2) Behavioral Pain Management (BPM). The OTM intervention consists of a collaborative care model in which a nurse care manager works closely with patients, primary care physicians (PCPs) and dialysis teams to develop and manage an individualized approach for analgesic optimization with focus on opioid tapering or transition to buprenorphine in all patients after consensual agreement with patient and PCP. The BPM combines two evidence based treatments - Acceptance and Commitment Therapy (ACT) for pain and Cognitive Behavioral Therapy (CBT) for co-existing depression/anxiety (when present) and is delivered via telemedicine during HD. The control condition not assigned to either OTM or BPM will be usual care and have the option to receive ACT at the end of 12 months. We will examine the effectiveness of OTM (versus no OTM, Aim 1) and BPM (versus no BPM, Aim 2) over 9-months for reducing opioid use (primary outcome) and improving pain severity (secondary outcome) in HD patients on chronic opioids. The implementation goal will take advantage of the diverse patient, provider and organizational settings in the HOPE Consortium to evaluate process outcomes for from multiple stakeholders (Aim 3). Our study combines novel tools and resources to decrease opioid related morbidity, address the opioid epidemic, alleviate pain for HD patients, in addition to providing insights to inform integration of these interventions into dialysis practice and policy.