EMPOWER: Evaluating the ability to reduce Morphine equivalent dose for chronic Pain patients receiving Opioid-therapy through a Web-based E-Health self-management program: a Randomized multi-site Clin

项目摘要-摘要： 慢性非癌症疼痛的治疗在很大程度上落到了初级保健医生的身上，由于 医疗保健系统的限制，完全依赖长期阿片类药物治疗(LOT)。基于不利的 结果和对LOT有效性的不充分证据，疾控中心最近开发了 旨在减少患者使用LOT和吗啡当量剂量(MED)的建议 收货批次。然而，大多数接受抽签人报告说，阿片类药物治疗显著 对控制他们的痛苦是有益的，甚至是关键的。使问题更加复杂的是，很难获得非 为许多患者提供药物治疗，特别是在农村和较低社会经济社区，因为 保险报销结构和有限的疼痛服务。测试的重要性 NIDA的新战略计划中提到了减少MED的辅助疗法，以及 评估可扩展的、因此更有可能使用的干预措施。慢性疼痛患者 越来越多地使用互联网获取信息和支持；因此，一个负担得起、有效的基于Web的 干预可以极大地增加获得疼痛治疗的机会。一个基于网络的慢性疼痛计划， 慢性疼痛管理计划(简称E-Health)包括多个培训技能的学习中心 如认知结构调整、情绪调节、目标设定、活动和锻炼促进、社交 支持、放松技巧和行为激活。学习活动可在4小时内完成- 一个月的订阅期，费用是25美元/月。先前两项随机对照试验的结果 (RCT)发现电子健康在减少疼痛和药物使用方面有效。虽然这些结果是 有希望的是，它们需要在更大的RCT中复制，患者在初级保健中接受治疗，在那里 大多数慢性疼痛患者都得到了治疗。本项目的具体目标是：1)开展区域合作研究 将E-Health+与常规治疗(TAU)进行比较。400例患者接受≥20 mg/d的治疗 对于初级保健中的慢性疼痛，两种医疗保健系统中的一种将以1：1的比例随机进行 TAU或TAU+E-Health(E-Health+)。Tau将包括初级保健医生的抽签；MED和 医生就诊将通过电子健康记录(EHR)进行跟踪。Tau将进一步被描述为 使用慢性病护理评估，该评估评估一个诊所使用六个 鼓励高质量护理的战略。参与者将在基线时完成评估，即 电子健康治疗4个月，治疗后6个月。2)测试我们的电子健康概念模型 变化机制，包括假设的中介因素(即疼痛自我效能、应对策略、知识 关于疼痛/阿片类药物治疗和压力)和调节因子(神经认知功能：执行功能和言语 学习能力)的电子健康的影响，减少MED和疼痛强度。

Project Summary-Abstract: The treatment of chronic non-cancer pain has largely fallen to primary care physicians who often, due to healthcare system constraints, rely exclusively on long-term opioid therapy (LOT). Based on the adverse consequences and inadequate evidence of effectiveness for LOT, the CDC recently developed recommendations designed to decrease the use of LOT and the morphine equivalent dose (MED) for patients receiving LOT. However, the majority of people receiving LOT report that opioid medication is significantly beneficial and even critical to managing their pain. Compounding the problem is poor access to non- pharmacologic therapies for many patients, particularly in rural and lower socioeconomic communities, due to insurance reimbursement structures and limited availability of pain services. The importance of testing adjunctive therapies to reduce MED was noted in NIDA’s new strategic plan as was the importance of evaluating interventions that are scalable and, thus, more likely to be used. Chronic pain patients are increasingly using the internet for information and support; hence an affordable and effective web-based intervention could dramatically increase access to pain treatment. A web-based chronic pain program, the Chronic Pain Management Program (referred to as E-health), includes multiple learning centers that train skills such as cognitive restructuring, emotion regulation, goal setting, activity and exercise promotion, social support, relaxation techniques, and behavioral activation. The learning activities can be completed within a 4- month subscription period, the cost of which is $25/month. The results of two prior randomized controlled trials (RCTs) found E-health to be efficacious in decreasing pain and medication use. While these results are promising, they need to be replicated in a larger RCT and with patients being treated in primary care, where the majority of chronic pain patients are treated. Specific aims for the present project are to: 1) Conduct a RCT comparing E-health+ to treatment as usual (TAU). Four hundred patients being treated with ≥20 mg/day MED for chronic pain at primary care practices within one of two healthcare systems will be randomized in a 1:1 ratio to TAU or to TAU plus E-health (E-health+). TAU will consist of LOT from a primary care physician; MED and physician visits will be tracked through the electronic health record (EHR). TAU will be further characterized using the Assessment of Chronic Illness Care, which assesses the degree to which a practice uses six strategies that encourage high-quality care. Participants will complete assessments at baseline, the end of the 4-month E-health treatment period, and at 6 months post-treatment. 2) Test our conceptual model of E-health’s mechanisms of change, including hypothesized mediators (i.e., pain self-efficacy, coping strategies, knowledge about pain/opioid therapy, and stress) and moderators (neurocognitive function: executive function and verbal learning ability) of E-health’s impact on decreasing MED and pain intensity.