Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Function and Quality of Life in Veterans

7.项目总结摘要 此疼痛管理协作实验室演示项目的总体目标是实施一个新的 慢性疼痛护理的整体健康范式，强调非药物疼痛自我管理 减少疼痛症状，改善退伍军人的整体功能和生活质量。这样做的目的是 UG3/UH3建议是开发和试点组件，将用于支持一个务实的 两种结构不同的疼痛护理提供方法的实施-效果试验， 全面性和强度。在试验阶段，来自4个不同地理位置的600多名退伍军人 有中度到重度慢性疼痛的退伍军人管理局卫生保健设施(无论慢性阿片类药物治疗)将 随机接受强化整体卫生团队(WHT)与非强化普通初级护理 关爱团体教育(PC-GE)方法。所有注册的退伍军人将被跟踪12个月。正在准备中 对于试验，为期2年的UG3阶段的具体目标包括：UG3目标1：使用以证据为基础的 实施框架，以进行形成性评估，让4VA的试验利益相关者参与进来 注册网站，征求对特定试验组件的反馈，并确定试验的障碍和促进者 实施和UG3目标2：使用利益攸关方的意见来调整、试点和完善关键组件 成功实施的务实试验包括：非药理学多模式疼痛自评 针对患者和提供者的管理教育、护理点数据收集应用程序、患者报告 对整体健康干预、手腕活动监测器和网络/移动应用程序敏感的措施 支持活体监测活动和疼痛，并为疼痛自我管理提供工具。假设 过渡到为期4年的UH3试验阶段，我们将在UG3阶段实施这些改进的组件。在UH3中 目标1我们将进行为期12个月的务实有效性试验，以测试中度至 严重慢性疼痛随机接受整体健康团队(WHT)干预的可能性比 接受初级护理团体教育(PC-GE)的人：H1：体验更好的疼痛严重程度和 干预、功能和生活质量(主要结果)；H2：减少高风险疼痛的使用 药物，包括阿片类药物，或高风险组合(次要)；H3：参与更多的非 药理疼痛管理活动(次级)；H4：体验改善共病心理健康 症状，包括睡眠问题和自杀。UH3目标2是进行流程评估和预算 两项干预措施的实施影响分析 用于扩展和传播的实施工具包。UG3/UH3疼痛管理合作实验室的结果 示范项目将有助于NIH/VA/DoD倡议的总体使命，即建立国家级 支持退伍军人和军人非药理性疼痛管理的基础设施。

7. PROJECT SUMARY ABSTRACT The overarching goal of this Pain Management Collaboratory Demonstration project is to implement a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacologic pain self-management that reduces pain symptoms and improves overall functioning and quality of life in veterans. The objective of this UG3/UH3 proposal is to develop and pilot components that will be used to support a pragmatic implementation-effectiveness trial of two pain care delivery approaches that differ in structure, comprehensiveness, and intensity. During the trial phase, over 600 veterans across 4 geographically diverse VA health care facilities with moderate to severe chronic pain (irrespective of chronic opioid therapy) will be randomized to receive an intensive Whole Health Team (WHT) versus a less intensive usual care Primary Care Group Education (PC-GE) approach. All enrolled veterans will be followed for 12 months. In preparation for the trial, specific aims of the 2-year UG3 phase include: UG3 Aim 1: to use an evidence-based implementation framework to conduct a formative evaluation that engages trial stakeholders at the 4 VA enrolling sites, solicits feedback on specific trial components, and identifies barriers to and facilitators of trial implementation, and UG3 Aim 2: to use stakeholder input to adapt, pilot and refine key components for the successful implementation of the pragmatic trial including: non-pharmacologic multi-modal pain self- management education for patients and providers, point-of-care data collection applications, patient reported measures sensitive to whole health interventions, wrist-worn activity monitors, and web/mobile applications to support in vivo monitoring of activity and pain and to provide tools for pain self-management. Assuming transition to the 4-year trial UH3 phase, we will implement these components refined in the UG3 phase. In UH3 Aim 1 we will conduct a 12-month pragmatic effectiveness trial to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: H1: Experience improved pain severity and interference, functioning and quality of life (primary outcome); H2: Decrease use of higher risk pain medications, including opioids, or high risk combinations (secondary); H3: Engage in a greater number of non- pharmacological pain management activities (secondary); H4: Experience improved comorbid mental health symptoms, including sleep problems and suicidality. UH3 Aim 2 is to conduct a process evaluation and budget impact analysis of the implementation of the two interventions to support the development of an implementation toolkit for scaling and dissemination. Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.