Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches

摘要 高冲击性慢性疼痛是持续性的，限制了十分之一的成年人的生活和工作活动。证据- 基于认知行为的慢性疼痛疗法(CBT-CP)被广泛接受、有效，但并不 依赖阿片类药物等药物。大多数接受CBT-CP培训的专业人员都在城市地区，因此需要 在医疗服务不足和农村地区提供这些服务。我们的三臂比较有效性试验将 严格评估两种低成本、可扩展的CBT-CP交付方式：通过已建立的 PainTRAINER程序和通过电话使用PainTRAINER组件。将与平时的护理进行比较 来自美国慢性疼痛协会的疼痛管理指南。我们的长期目标是 增加CBT-CP的可获得性，特别是对受阿片类药物危机影响的社区。我们的目标：1、在一个 规划阶段，细化战略以识别和招募患者，最终确定干预程序，以及 确保数据基础设施和质量。2、确定网上宣传有效性的初步结果 电话CBT-CP对患者疼痛严重程度和二次结局(包括抑郁、睡眠、质量)的影响 来自电子健康记录的生命、与疼痛相关的医疗保健利用情况。我们会给病人做检查， 减轻疼痛严重程度的系统因素和基于理论的媒介的作用，如灾难 和自我效能感；以及进行形成性和终结性评估：理解、描述和 解释干预措施采用、实施和可持续性方面的障碍和促进者。3、评估 与常规护理相比，在线和电话CBT-CP的成本和增量成本效益。我们的 人群是患有高度影响的慢性疼痛的成年人，他们在四个不同的医疗系统中接受护理。 符合条件的、同意的参与者将随机接受两种PainTRAINER干预之一或通常 关心。干预将是每周8次，45分钟的在线计划或远程医疗风格的电话 由训练有素的行为健康专家进行指导。自我报告的疼痛严重程度和次要结果将 在基线以及3、6和12个月时进行评估。允许纵向数据的回归模型 评估时间和随机化ARM之间的交互作用将用于评估干预效果 在12个月内，该项目的主要终点涉及国家优先事项，包括确定有效、 低成本、低风险的疼痛管理护理模式，特别是自我管理的行为治疗 易于实施和传播的文件。如果有效，在线和电话油漆传送器CBT-CP 有可能在全国范围内传播，类似于电话戒烟和减肥干预 损失，以减轻个人和经济负担的慢性疼痛。

SUMMARY High impact chronic pain is persistent and limits life and work activities for one in ten adults. Evidence- based cognitive-behavioral therapy for chronic pain (CBT-CP) is widely accepted, effective, and does not rely on drugs such as opioids. Most professionals trained in CBT-CP are in urban areas, creating a need for these services in medically underserved and rural areas. Our three-arm comparative effectiveness trial will rigorously evaluate two low-cost, scalable ways to deliver CBT-CP: online via the established PainTRAINER program and by phone using PainTRAINER components. Comparison will be to usual care with a pain-management guide from the American Chronic Pain Association. Our long-term objective is increasing CBT-CP availability, especially for communities affected by the opioid crisis. Our aims: 1, In a planning phase, refine strategies to identify and recruit patients, finalize intervention procedures, and ensure data infrastructure and quality. 2, Determine the primary outcome of effectiveness of online and telephonic CBT-CP on patients' pain severity and secondary outcomes including depression, sleep, quality of life, and pain-related healthcare utilization from the electronic health record. We will examine patient and system factors that reduce pain severity and the role of theory-based mediators such as catastrophizing and self-efficacy; as well as conduct formative and summative evaluations to: understand, describe, and explain barriers and facilitators to intervention adoption, implementation and sustainability. 3, Assess the cost and incremental cost-effectiveness of online and telephonic CBT-CP compared to usual care. Our population is adults with high impact chronic pain who receive care in one four diverse healthcare systems. Eligible, consenting participants will be randomized to one of the two PainTRAINER interventions or usual care. Interventions will be 8 weekly, 45-minute sessions of the online program or telehealth-style phone coaching by trained behavioral health specialists. Self-reported pain severity and secondary outcomes will be assessed at baseline and at 3, 6, and 12 months. Regression models for longitudinal data allowing interactions between assessment time and randomization arm will be used to estimate intervention effects at 12-months, the primary endpoint This project addresses national priorities including identifying effective, low-cost, low-risk care models for pain management, especially behavioral treatments for self-management that are readily implemented and disseminated. If effective, online and telephonic PainTRAINER CBT-CP have the potential to spread nationally, similar to phone interventions for tobacco cessation and weight loss, to reduce the personal and economic burdens of chronic pain.