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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

EMPOWER：评估通过基于网络的电子健康自我管理计划减少接受阿片类药物治疗的慢性疼痛患者吗啡当量剂量的能力：随机多站点临床

基本信息

批准号：
10174898
负责人：
T John WINHUSEN
金额：
$ 41.37万
依托单位：
UNIVERSITY OF CINCINNATI
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-01 至 2023-06-30
项目状态：
已结题

项目摘要

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.

项目摘要-摘要：慢性非癌性疼痛的治疗主要由初级保健医生负责，由于医疗系统的限制，完全依赖于长期阿片类药物治疗（LOT）。根据不良结果和有效性的证据不足的LOT，疾病预防控制中心最近开发旨在减少患者使用LOT和吗啡等效剂量（MED）的建议收到很多。然而，大多数接受LOT的人报告说，阿片类药物是显着的这对控制他们的疼痛是有益的，甚至是至关重要的。使问题更加复杂的是，药物治疗对许多患者，特别是在农村和较低的社会经济社区，由于保险报销结构和疼痛服务的可用性有限。测试的重要性 NIDA的新战略计划中指出了减少MED的连续疗法，评估可扩展的干预措施，从而更有可能被使用。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，干预可以大大增加获得疼痛治疗的机会。一个基于网络的慢性疼痛项目，慢性疼痛管理计划（简称为电子健康），包括多个学习中心，培训技能例如认知重建、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。学习活动可以在4- 一个月的订阅期，费用为25美元/月。两项先前的随机对照试验的结果随机对照试验（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，他们需要在一个更大的随机对照试验和患者正在接受治疗的初级保健，其中大多数慢性疼痛患者得到治疗。本项目的具体目标是：1）进行随机对照试验将电子健康+与常规治疗（TAU）进行比较。400例患者接受≥20 mg/天MED治疗对于两个医疗保健系统之一的初级保健实践中的慢性疼痛，将以1：1的比例随机分配 TAU或TAU+电子健康（E-health+）。TAU将包括来自初级保健医生的LOT; MED和将通过电子健康记录（EHR）跟踪医生就诊情况。TAU将进一步表征使用慢性病护理评估，评估实践中使用六种鼓励高质量护理的战略。参与者将在基线时完成评估， 4-电子健康治疗期间和治疗后6个月。2)测试我们的电子健康概念模型变化的机制，包括假设的调解人（即，疼痛自我效能，因应策略，知识关于疼痛/阿片类药物治疗和压力）和调节剂（神经认知功能：执行功能和言语功能）学习能力）的电子健康的影响，减少MED和疼痛强度。