Video-Telecare Collaborative Pain Management to Improve Function and Reduce Opioid Risk in Patients with End Stage Renal Disease Receiving Hemodialysis

项目摘要/摘要 接受血液透析(HD)的终末期肾病(ESRD)患者通常会经历慢性疼痛， 导致接受长期阿片类药物治疗(LTOT)的人数不成比例。由于一般情况下 LTOT的不利风险-收益概况，当前的共识指南促进1)持续重新评估 阿片类药物的益处和风险以及2)在促进疼痛自我管理的同时减少或停止LTOT 当益处不再大于伤害时，策略和非阿片类疼痛护理。最优LTOT的研究 逐渐减少的策略已经落后于临床需要，服用HD的患者可能特别容易受到 由临床惰性引起的问题。我们的团队已经开发了基于证据的干预措施来解决 LTOT缩减的临床惰性。首先，合作阿片类药物重新评估方案(CORP)包括 药剂师-医生团队，对患者经历的情况进行深入评估和管理 与安全性或有效性或阿片类药物有关的问题，提供丁丙诺啡的轮换，丁丙诺啡是一种部分MU阿片受体 激动剂，作为一种非常有前途的缩减策略。公司可以使用视频远程医疗进行虚拟交付。 合作疼痛教育和自我管理(COPES)是一项认知-行为疗法(CBT)计划 通过远程医疗提供改善疼痛干扰的服务，这是共识推荐的最优先疼痛 结果衡量标准。虽然Corp和COPE是既定的干预措施，但是否提供轮换到 丁丙诺啡作为Corp(Corp-B)的一部分提供给所有患者，以及是否所有尝试缩减的患者都将 为接受HD的患者量身定做的COPES的益处(COPES-HD)是重要的未研究问题， 将这项工作借给顺序、多分配随机试验(SMART)设计，允许适应 在病人护理的关键决策点根据先验反应标准进行的干预。我们建议 适应公司和应对接受HD和LTOT的患者，并以务实的方式测试其有效性 随机化的聪明。最初的随机化将是比较公司支持的缩减与(公司-B)和 不使用丁丙诺啡轮换对LTOT剂量减少和疼痛的6个月综合结果的影响 回应。对初始治疗的反应将在随机化后的3-8周内进行评估；未能做到的人 符合先验标准的响应将立即切换到另一个ARM并随机到 无论是否使用COPES-HD进行增强，应答者将继续进行初始治疗，并被随机分配到 使用COPES进行增强-高清或非高清。这一创新的设计将使我们能够确定八个 适应性治疗策略导致6个月阿片类药物剂量和疼痛干扰的最大减少。这个 这一提议的新颖方面包括：1)使用智能设计，2)结合以疼痛为重点的 药剂师/医生团队使用远程医疗和丁丙诺啡，3)CBT对阿片类药物的增强试验 逐渐减少，以及4)实用的设计。这项研究是由一个经历过疼痛、肾脏和成瘾的团队进行的 研究人员希望找到一种有效的策略来解决接受HD的患者的LTOT问题。

Project Summary/Abstract Patients with end-stage renal disease (ESRD) receiving hemodialysis (HD) commonly experience chronic pain, resulting in a disproportionate number receiving long-term opioid therapy (LTOT). Due to the generally unfavorable risk-benefit profile of LTOT, current consensus guidelines promote 1) continuous re-assessment of benefit and risk of opioids and 2) reduction or discontinuation of LTOT while boosting pain self-management strategies and non-opioid pain care when benefit no longer outweighs harm. Research on optimal LTOT tapering strategies has lagged behind clinical need and patients on HD may be especially vulnerable to the problems resulting from clinical inertia. Our team has developed evidence-based interventions addressing clinical inertia in LTOT tapering. First, the Collaborative Opioid Reassessment Program (CORP) consists of a pharmacist-physician team that performs in-depth assessment and management of patients experiencing issues related to safety or efficacy or opioids, offering rotation to buprenorphine, a partial mu opioid receptor agonist, as a highly promising taper strategy. CORP can be delivered virtually using video-telehealth. Cooperative Pain Education and Self-Management (COPES) is a cognitive-behavioral therapy (CBT) program delivered via telehealth that improves pain interference, the consensus-recommended highest priority pain outcome measure. While CORP and COPES are established interventions, whether to provide rotation to buprenorphine to all patients as part of CORP (CORP-B) and whether all patients attempting a taper would benefit from COPES tailored for patients receiving HD (COPES-HD) are important unstudied questions, lending this work to a sequential, multiple assignment randomized trial (SMART) design that allows adaption of the intervention at critical decision points in a patient's care based on a priori response criteria. We propose to adapt CORP and COPES for patients receiving HD and LTOT and to test their effectiveness in a pragmatic randomized SMART. Initial randomization will be to compare CORP-supported taper with (CORP-B) and without (CORP) buprenorphine rotation on the 6-month composite outcome of LTOT dose reduction and pain response. Response to initial treatment will be assessed in weeks 3-8 post randomization; those who fail to meet a priori criteria for response will be immediately switched to the other arm and randomized to augmentation with COPES-HD or not, responders will remain on their initial treatment and be randomized to augmentation with COPES-HD or not. This innovative design will allow us to determine which of the eight adaptive treatment strategies leads to the greatest reduction in 6-month opioid dose and pain interference. The novel aspects of this proposal include: 1) the use of a SMART design, 2) the combination of a pain-focused pharmacist/physician team using telehealth and buprenorphine, 3) a test of CBT augmentation to opioid tapering, and 4) a pragmatic design. This study, conducted by a team of experienced pain, renal and addiction researchers, holds promise of identifying an effective strategy for addressing LTOT in patients receiving HD.