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

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 - 管理补充

基本信息

批准号：
10884838
负责人：
LYNN L. DeBAR
金额：
$ 56.68万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
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/10884838
关键词：
Address Adoption Adult Affect American Anxiety Behavior Therapy Body Weight decreased Caring Clinical Cognitive Therapy Communities Comparative Effectiveness Research Consent Cost Analysis Data Economic Burden Eligibility Determination Health system Healthcare Systems Heterogeneity Intervention Life Mediator Medically Underserved Area Mental Depression Mental Health Methods Modeling Mood Disorders Opioid Outcome Pain Pain intensity Pain management Participant Patient Self-Report Patients Persons Pharmaceutical Preparations Pharmacotherapy Physical Function Population Public Health Qualitative Evaluations Quality of life Randomized Residencies Risk Role Rural Rural Population Secondary pain Self Efficacy Self Management Services Severities Site Sleep Sleep disturbances Subgroup System Telephone Testing Time Training Work arm care systems chronic pain chronic pain management comorbidity comparative effectiveness trial comparison intervention contextual factors cost effective therapy effectiveness evaluation evidence base experience impression improved incremental cost-effectiveness intervention effect medically underserved medically underserved population opioid epidemic opioid therapy opioid use pain catastrophizing pain model pain outcome pain reduction primary endpoint primary outcome programs remote delivery rural area rural underserved secondary outcome sex social health determinants success telehealth telephone delivery theories therapy design three-arm study tobacco cessation intervention treatment arm treatment as usual treatment effect treatment response underserved area urban area virtual virtual coach

项目摘要

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: (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program, and 2) a previously developed and tested 8-session on-line CBT- CP based program (painTRAINER). Comparison will be to usual care augmented with a guide to chronic pain management by the American Chronic Pain Association. Our long-term objective is increasing CBT-CP availability, especially for communities affected by the opioid crisis. This study aims to determine the effectiveness of the telephonic CBT-CP and online program on improving patients’ pain severity (primary outcome) as well as their impact on additional outcomes including quality of life, depression, sleep and long- term opioid use. 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 qualitative evaluations to understand, describe, and explain barriers and facilitators to intervention adoption, implementation and sustainability. The cost and incremental cost-effectiveness of the telephonic CBT-CP and online program will also be assessed compared to each other and usual care. Our population is adults with high impact chronic pain who receive care in one of four diverse healthcare systems. Eligible, consenting participants will be randomized to one of the three study arms. 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 3 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 can be readily implemented and disseminated. If effective, these remotely delivered CBT-CP programs 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.

总结高冲击性慢性疼痛是持续性的，并限制了十分之一成年人的生活和工作活动。循证慢性疼痛的认知行为疗法（CBT-CP）被广泛接受，有效，并且不依赖于药物，如阿片类药物。大多数接受CBT-CP培训的专业人员都在城市地区，因此需要这些在医疗服务不足和农村地区提供服务。我们的三组比较有效性试验将严格评估两种低成本，可扩展的方式来提供CBT-CP：（1）8个会议，一对一，专业提供电话/视频CBT-CP计划，以及2）先前开发和测试的8节在线CBT- 基于CP的程序（painTRAINER）。将与常规护理进行比较，并增加慢性疼痛指南美国慢性疼痛协会（American Chronic Pain Association）我们的长期目标是增加CBT-CP 供应，特别是受阿片类危机影响的社区。本研究旨在确定电话CBT-CP和在线程序对改善患者疼痛严重程度的有效性（主要结果）以及它们对其他结果的影响，包括生活质量、抑郁、睡眠和长期术语阿片类药物使用。我们将研究降低疼痛严重程度的患者和系统因素以及理论的作用- 基于中介，如灾难化和自我效能;以及进行定性评估，理解、描述和解释干预措施采用、实施和持续发展电话CBT-CP和在线计划的成本和增量成本效益将也可以与平时的护理进行比较。我们的人口是成年人，在四个不同的医疗保健系统之一接受护理的疼痛。合格的、同意的参与者将随机分配至三个研究组之一。自我报告的疼痛严重程度和次要结局将在基线以及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3时的干预效果月，主要终点。该项目涉及国家优先事项，包括确定有效的、低成本的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，可以很容易地实施和传播。如果有效，这些远程交付的CBT-CP计划在全国范围内推广的潜力，类似于戒烟和减肥的电话干预，减轻慢性疼痛的个人和经济负担。