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

针对慢性疼痛的定制非药物治疗服务：测试可扩展且务实的方法

• 批准号: 10264127
• 负责人: LYNN L. DeBAR
• 金额: $ 387.22万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10264127
• 关键词: Address; Adoption; Adult; Affect; American; Anxiety; Behavior Therapy; Body Weight decreased; Caring; Clinical; Clinical Data; Cognitive Therapy; Communities; Comparative Effectiveness Research; Complex; Consent; Coping Skills; Cost Analysis; Data; Disease; Economic Burden; Electronic Health Record; Ensure; Evaluation; Healthcare; Healthcare Systems; Information Technology; Infrastructure; Intervention; Intervention Studies; Life; Measures; Mediator of activation protein; Medically Underserved Area; Mental Depression; Mental disorders; Methods; Modality; Modeling; Moods; Motivation; Opioid; Outcome; Pain; Pain management; Participant; Patient Recruitments; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Population; Primary Care Physician; Primary Health Care; Problem Solving; Procedures; Public Health; Quality of life; Randomized; Risk; Role; Rural Population; Self Efficacy; Self Management; Services; Severities; Sleep; Specialist; Substance abuse problem; System; Telephone; Testing; Time; Training; Work; arm; base; behavioral health; care systems; chronic pain; clinical practice; comorbidity; comparative effectiveness trial; cost; data infrastructure; data quality; effective therapy; effectiveness evaluation; effectiveness outcome; evidence base; health care service organization; health care service utilization; improved; improved outcome; incremental cost-effectiveness; intervention effect; medically underserved; medically underserved population; online intervention; opioid epidemic; opioid therapy; opioid use; pain catastrophizing; pain model; pain reduction; patient population; performance site; practice setting; prescription opioid; primary endpoint; primary outcome; programs; recruit; rural underserved; secondary outcome; sleep quality; telehealth; telephone coaching; theories; tobacco cessation intervention; treatment as usual; underserved rural area; urban area

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.

概括 高影响的慢性疼痛是持续性的，限制了十分之一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) 已被广泛接受、有效且不 依赖阿片类药物等药物。大多数接受过 CBT-CP 培训的专业人员都在城市地区，因此需要 这些服务适用于医疗服务不足的地区和农村地区。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： 通过既定的在线方式 PainTRAINER 程序和通过电话使用PainTRAINER 组件。与平常护理进行比较 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 的可用性，特别是对于受阿片类药物危机影响的社区。我们的目标： 1、 规划阶段，完善识别和招募患者的策略，最终确定干预程序，以及 确保数据基础设施和质量。 2、确定线上和线下有效性的主要结果 电话 CBT-CP 评估患者的疼痛严重程度和次要结果，包括抑郁、睡眠、质量 电子健康记录中的生命和与疼痛相关的医疗保健利用。我们将检查患者并 减轻疼痛严重程度的系统因素以及基于理论的调解因素（例如灾难化）的作用 和自我效能感；以及进行形成性和总结性评估，以：理解、描述和 解释干预措施的采用、实施和可持续性的障碍和促进因素。 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 人口是患有严重慢性疼痛的成年人，他们在四个不同的医疗系统之一中接受护理。 符合条件且同意的参与者将被随机分配接受两种 PainTRAINER 干预措施之一或常规干预措施 关心。干预措施将是每周 8 次、每次 45 分钟的在线计划或远程医疗式电话会议 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。纵向数据的回归模型允许 评估时间和随机分组之间的相互作用将用于估计干预效果 12 个月时的主要终点 该项目涉及国家优先事项，包括确定有效、 用于疼痛管理的低成本、低风险护理模式，特别是用于自我管理的行为治疗 易于实施和传播。如果有效，在线和电话 PainTRAINER CBT-CP 有可能在全国范围内传播，类似于针对戒烟和体重的电话干预 损失，以减轻慢性疼痛的个人和经济负担。