Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP-WH)

这个项目解决了对慢性疼痛实施有效的、非阿片类药物干预的重大挑战。 2农村和偏远地区居住的退伍军人的管理。疼痛是一种复杂的生物物理、心理和社会 3(BPS)状况，有越来越多的证据支持几种互补和综合的健康(CIH) 4种方法，可以更全面地解决疼痛问题。虽然退伍军人管理局已经成为推动CIH通过 5在其整个卫生倡议中，仍然存在许多障碍，特别是对农村患者而言。我们的团队与 6多层次的退伍军人利益相关者(包括农村患者)，这是一种创新的基于证据的远程医疗干预措施， 7是在我们团队先前研究的基础上发展起来的。深入农村的退伍军人：运用身心技能治疗疼痛 8全面健康远程健康干预(RAMP-WH)项目战略性地结合了多种基于证据的CIH自我 9解决退伍军人BPS需求和克服现有障碍的管理战略。包括疼痛教育， 10正念、疼痛特定练习和认知行为策略，该计划具有凝聚力和可扩展性。设计 11通过其全国性的全健康系统倡议在退伍军人管理局内实施，它使用退伍军人管理局整体健康(WH) 12名教练作为项目促进者。RAMP-WH是一个为期12周的计划，包括与WH教练进行1对1的培训，随后 13-11个小组会议，包括预先录制的专家指导的教育视频、身心技能培训和练习，以及 14促进了讨论。在筹备阶段(UG3)，我们将开展1)利益攸关方参与活动，包括 15确定和发展新的社区伙伴关系，并使用混合方法从多个层面收集数据 16个利益相关者(n=35-50名患者、社区合作伙伴、退伍军人医疗保健系统负责人和工作人员)，由既定的 17 RE-AIM/PRISM框架，以了解可能影响长期采用的关键因素；以及2)进行 18-40例农村VA慢性疼痛患者评估实施RAMP-WH的可行性(实验干预 19 UH3试验)在招募和参与、干预忠诚度和忠诚度、数据收集和其他关键方面 20个指标。对于UH3阶段，我们将进行随机混合类型2有效性-实施多站点 在退伍军人管理局的农村患者(n=500)中进行的21项RAMP-WH与常规护理的务实临床试验 22系统。UH3目标1将根据初步效果结果评估RAMP-WH的相对效果 在13周和26周时疼痛干预的23%和次要结果，包括阿片类药物的使用和其他建议的治愈 24个结果。在UH3目标2中，我们将与多个级别的利益相关者(来自UG3)迭代合作，以评估 试验中使用的25种干预实施策略，并调整这些策略以在 26全国退伍军人保健系统。这将包括：a)对利益攸关方进行混合方法评估； 27随机试验参与者对与实施相关的障碍和促进者、资源需求和其他RE- 28个AIM/PRISM领域；b)与利益攸关方合作，共同制定更多看似合理的战略，以克服 29实施RAMP-WH；以及c)使用利益攸关方意见提供的模型进行预算影响分析，以 30为未来的决策提供信息。 31

1 This project addresses the significant challenge of implementing effective, non-opioid interventions for chronic pain 2 management in rural and remote dwelling Veteran populations. Pain is a complex biophysical, psychological, and social 3 (BPS) condition and there is a growing evidence base to support several complementary and integrative health (CIH) 4 approaches, which can address pain in a more holistic way. While the VA has become a leader in advancing CIH through 5 its Whole Health Initiative, there remain many barriers, especially for rural patients. Our team has co-developed, with 6 multiple-levels of VA stakeholders (including rural patients), an innovative telehealth evidence-based intervention that 7 builds upon our team's previous research. The Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a 8 Whole Health Telehealth Intervention (RAMP-WH) project strategically coalesces multiple evidence based CIH self- 9 management strategies to address Veterans' BPS needs and overcome existing barriers. Comprised of pain education, 10 mindfulness, pain specific exercises, and cognitive behavioral strategies, the program is cohesive and scalable. Designed 11 to be implemented within the VA through its nationwide Whole Health System initiative, it uses VA Whole Health (WH) 12 coaches as program facilitators. RAMP-WH is a 12-week program including a 1-to-1 session with a WH Coach, followed 13 by 11 group sessions including pre-recorded expert led education videos, mind-body skill training and practice, and 14 facilitated discussions. For the preparatory phase (UG3) we will conduct 1) stakeholder engagement activities including 15 identifying and developing new community partnerships and using mixed methods data collection from multiple levels of 16 stakeholders (n=35-50 patients, community partners, VA healthcare system leaders and staff), guided by the established 17 RE-AIM/PRISM framework, to learn about key factors that can affect long-term adoption; and 2) conduct a pilot study of 18 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP-WH (experimental intervention for 19 the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key 20 metrics. For the UH3 Phase, we will conduct a randomized hybrid type 2 effectiveness-implementation multi-site 21 pragmatic clinical trial of RAMP-WH compared to Usual Care, among rural patients (n=500) in the VA healthcare 22 system. UH3 Aim 1 will assess the relative effectiveness of RAMP-WH in terms of the primary effectiveness outcome 23 of pain interference at 13 and 26 weeks and secondary outcomes including opioid use and other HEAL recommended 24 outcomes. In UH3 Aim 2 we will work iteratively with multiple levels of stakeholders (from UG3) to evaluate 25 intervention implementation strategies used in the trial and adapt these strategies to scale up RAMP-WH within the 26 national VA healthcare system. This will include: a) conducting mixed-methods assessments of stakeholder and 27 randomized trial participant views of implementation-related barriers and facilitators, resource needs, and other RE- 28 AIM/PRISM domains; b) working with stakeholders to co-create additional plausible strategies for overcoming barriers to 29 implementation of RAMP-WH; and c) conducting budget impact analyses using models informed by stakeholder views to 30 inform future decision making. 31