Options for Pain Management using Nonpharmacological Strategies (OPTIONS)

背景：对阿片类药物相关危害的反应和支持非药物治疗的证据 (NPTS)对于慢性疼痛，VHA优先考虑多种疼痛治疗方法，其中包括证据- 基于NPT的。然而，非正规技术一直未得到充分利用，老兵级别的障碍仍然很大。 未寻址。选项(使用非药物策略进行疼痛管理的选项)是重点 克服使用和遵守NPT的老兵级别的障碍，1)帮助患者做出决定 了解和比较《不扩散核武器条约》选项，找出最符合其目标和生活方式的NPT，以及2)a) 使用激励性访谈来培养自我效能感的教练，让退伍军人准备好与他们的 并建立患者的信心，以应对非手术治疗带来的痛苦。 意义：OPTIONS通过关注行为健康直接回应HSR&D的阿片类药物恳求 以及退伍军人参与非药物治疗。选项还支持2016年全面 《成瘾和康复法案》和许多退伍军人管理局指令侧重于增加非专利药品的可用性。 创新/影响：尽管有越来越多的证据表明非营利组织的有效性，但明显缺乏研究 旨在克服患者层面对《不扩散条约》使用的障碍。这是一个阻碍疼痛管理的严重缺口。 以及减少对阿片类药物依赖的目标。OPTIONS是第一个使用定制的、以患者为中心的研究 解决患者层面吸收和遵守非专利技术的障碍的方法。因此，Options提供了 对退伍军人管理局旨在促进非营利组织的全系统努力的重要补充，并有助于确保退伍军人管理局的 对这些倡议的大量投资导致更多地使用非正规技术，并改善退伍军人的成果。 我们与退伍军人管理局和以患者为中心的护理和文化办公室的合作伙伴关系 转型将通过利用现有的Whole Health指导来促进选项的实施，如果是 积极尝试--进一步增强这一提议的影响。 具体目标：目标1：测试选项干预对疼痛干预的效果(主要结果) 患有慢性疼痛的退伍军人。 目标2：测试备选方案干预措施对《不扩散核武器条约》使用和二次成果的影响(与健康有关的质量 生命、心理功能、病人活力)。 目标3：确定实施备选干预措施的促进者和障碍。 方法：此混合类型1研究将测试有效性，同时检查实施促进者和 障碍。296名患有慢性肌肉骨骼疼痛的退伍军人将随机接受干预(10周 使用激励性面试和NPT上的选项决策辅助进行指导)或到等待名单控制臂。 我们将在基线、3个月、6个月和9个月检查结果。在目标3中，我们将使用定性方法来 通过访谈了解未来实施的促进者和障碍 退伍军人和接受OPTIONS干预的PCP患者。 实施/下一步：在等待积极结果之前，我们的下一步将是多站点混合类型2 有效性-实施试验，在此试验中，我们将评估实施情况，同时继续测试 有效性。我们将与运营合作伙伴合作，通过以下方式实施选项干预 现有的Whole Health教练，从而帮助确保可持续性。此外，来自目标3的调查结果， 其中审查了执行方面的障碍和促进者，将有助于指导这些下一步行动。

Background: In response to opioid-related harms and evidence supporting nonpharmacological treatments (NPTs) for chronic pain, VHA has prioritized multimodal pain treatment approaches that include evidence- based NPTs. However, NPTs are persistently underutilized, and Veteran-level barriers remain largely unaddressed. OPTIONS (Options for Pain management using Nonpharmacological Strategies) is focused on overcoming Veteran-level barriers to NPT use and adherence with 1) a decision aid to help patients understand and compare NPT options and find NPTs that work best with their goals and lifestyle, and 2) a coach who uses motivational interviewing to foster self-efficacy, prepare Veterans to discuss NPTs with their providers, and build patients’ confidence to manage their pain with NPTs. Significance: OPTIONS is directly responsive to HSR&D’s Opioid Solicitation by focusing on behavioral health and engagement of Veterans in non-medication treatments. OPTIONS also supports the 2016 Comprehensive Addiction and Recovery Act and numerous VA directives focused on increasing availability of NPTs. Innovation/Impact: Despite mounting evidence on the effectiveness of NPTs, there is a distinct lack of research aimed at overcoming patient-level barriers to NPT use. This is a critical gap that impedes pain management and the goal of reducing reliance on opioids. OPTIONS is the first study to use a tailored, patient-centered approach to address patient-level barriers to uptake of and adherence to NPTs. As such, OPTIONS provides an important complement to VA’s system-wide efforts aimed at promoting NPTs and helps ensure that VA’s substantial investment in these initiatives leads to increased use of NPTs and improved Veteran outcomes. Our partnership with VA Pain Management and the Office of Patient-Centered Care and Cultural Transformation will facilitate implementation of OPTIONS by leveraging existing Whole Health coaches if it is a positive trial—further enhancing the impact of this proposal. Specific Aims: Aim 1: Test the OPTIONS intervention’s effects on pain interference (primary outcome) among Veterans with chronic pain. Aim 2: Test the OPTIONS intervention’s effects on NPT use and secondary outcomes (health-related quality of life, psychological functioning, patient activation). Aim 3: Identify facilitators and barriers to implementing the OPTIONS intervention. Methodology: This Hybrid Type 1 study will test effectiveness while examining implementation facilitators and barriers. 296 Veterans with chronic musculoskeletal pain will be randomized to the intervention (10 weeks of coaching using motivational interviewing and the OPTIONS decision aid on NPTs) or to a waitlist control arm. We will examine outcomes at baseline and 3, 6 and 9 months. In Aim 3, we will use qualitative methods to understand facilitators and barriers to future implementation via interviews with a subset of intervention Veterans and with PCPs whose patients received the OPTIONS intervention. Implementation/Next Steps: Pending positive results, our next step will be a multi-site hybrid type 2 effectiveness-implementation trial, in which we will evaluate for implementation while continuing to test for effectiveness. We will work with our operational partners to implement the OPTIONS intervention using existing Whole Health Coaches, thereby helping to ensure sustainability. In addition, findings from Aim 3, which examines barriers and facilitators to implementation, will help to guide these next steps.