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.项目摘要 这个疼痛管理合作实验室示范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模式，强调非药物疼痛自我管理， 减轻疼痛症状，改善退伍军人的整体功能和生活质量。的目的 UG 3/UH 3建议是开发和试验将用于支持务实的 两种结构不同的疼痛护理提供方法的实施有效性试验， 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 患有中度至重度慢性疼痛的VA医疗保健机构（无论是否接受慢性阿片类药物治疗）将 随机接受强化整体健康团队（WHT）与不太强化的常规护理初级 护理小组教育（PC-GE）方法。所有登记的退伍军人将被跟踪12个月。在制备 对于试验，2年UG 3阶段的具体目标包括：UG 3目标1：使用基于证据的 实施框架，以进行形成性评价，让4VA的试验利益相关者参与 招募研究中心，征求对特定试验组成部分的反馈，并确定试验的障碍和促进因素 目标2：利用利益攸关方的投入，调整、试行和完善 成功实施的务实试验，包括：非药物多模式疼痛自我， 针对患者和提供者的管理教育、床旁数据收集应用程序、患者报告 对整体健康干预、腕戴式活动监测器和网络/移动的应用程序敏感的措施， 支持活动和疼痛的体内监测，并提供疼痛自我管理的工具。假设 为了过渡到为期4年的试验UH 3阶段，我们将实施在UG 3阶段改进的这些组件。在UH 3 目标1：我们将进行一项为期12个月的务实有效性试验，以测试中度至中度 随机接受全健康团队（WHT）干预的严重慢性疼痛患者比 接受初级保健小组教育（PC-GE）的患者：H1：疼痛严重程度改善， 干预、功能和生活质量（主要结局）; H2：减少使用高风险疼痛 药物，包括阿片类药物，或高风险组合（次要）; H3：参与更多的非药物治疗， 药物性疼痛管理活动（次要）; H4：共病心理健康状况改善 症状，包括睡眠问题和自杀倾向。UH 3目标2是进行过程评估和预算 对执行两项干预措施的影响进行分析，以支持制定一项 用于扩展和传播的实施工具包。此UG 3/UH 3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， 基础设施，支持退伍军人和军事服务人员的非药物疼痛管理。

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.