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.

项目摘要提取：慢性非癌疼痛的治疗大大落到了初级保健医生，他们经常由于医疗保健系统的限制仅依赖于长期阿片类药物疗法（LOT）。基于逆境疾病预防控制中心最近开发了后果和有效性的证据旨在减少患者批次使用和吗啡等效剂量（MED）的建议接收地段。但是，大多数收到批次报告的人中的阿片类药物是显着的有益，甚至对管理痛苦至关重要。解决问题的复杂性是对非 - 许多患者的药理学疗法，尤其是在粗糙和较低的社会经济社区中保险报销结构和疼痛服务的可用性有限。测试的重要性 NIDA的新战略计划中注意到了减少药物的辅助疗法，这是评估可扩展的干预措施，因此更有可能使用。慢性疼痛患者是越来越多地使用互联网以获得信息和支持；因此，负担得起且有效的基于网络的干预可能会大大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（称为电子健康），包括多个培训技能的学习中心诸如认知餐厅，情绪调节，目标设定，活动和练习促进，社会支持，放松技术和行为激活。学习活动可以在4-之内完成月份订阅期，其费用为每月25美元。两个先前随机对照试验的结果（RCT）发现电子健康在减轻疼痛和药物使用方面有效。虽然这些结果是有希望的是，他们需要在较大的RCT中复制，并在初级保健中接受治疗，大多数慢性疼痛患者接受治疗。本项目的具体目标是：1）进行RCT 像往常一样将电子卫生+与治疗（TAU）进行比较。四百名患者接受≥20mg/天药物治疗对于在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的比例随机分配到tau或tau Plus E-Health（E-Health+）。 Tau将由初级保健医师组成。医学和医师就诊将通过电子健康记录（EHR）进行跟踪。 Tau将进一步描述使用评估慢性病护理，该护理评估了一种实践使用六个的程度鼓励高质量护理的策略。参与者将在基线上完成评估， 4个月的电子卫生治疗期，治疗后6个月。 2）测试我们电子健康的概念模型变革的机制，包括假设的调解人（即疼痛自我效能感，应对策略，知识关于疼痛/阿片类药物疗法以及压力）和主持人（神经认知功能：执行功能和言语学习能力）电子健康对降低药物和疼痛强度的影响。