Options for Pain Management using Nonpharmacological Strategies (OPTIONS)

使用非药物策略的疼痛管理选项（选项）

• 批准号: 10534972
• 负责人: Marianne Matthias
• 金额: --
• 依托单位: RLR VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-01 至 2026-10-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10534972
• 关键词: Address; Adherence; Affect; Area; Behavior; Belief; Chronic; Cognitive Therapy; Communities; Complement; Complementary Health; Control Groups; Decision Aid; Effectiveness; Ensure; Fostering; Future; Goals; Guidelines; Hybrids; Individual; Integrative Medicine; Intervention; Interview; Investments; Life; Life Style; Light; Maintenance; Methodology; Modality; Motivation; Opioid; Outcome; Pain; Pain interference; Pain management; Patient-Centered Care; Patients; Pharmaceutical Preparations; Policies; Provider; Qualitative Methods; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Recovery; Reporting; Research; Research Design; Risk; Sampling; Self Efficacy; Site; System; Testing; Time; Variant; Veterans; Waiting Lists; Work; addiction; arm; behavioral health; chronic musculoskeletal pain; chronic pain; chronic pain management; effectiveness testing; effectiveness/implementation trial; evidence base; future implementation; group intervention; health related quality of life; hybrid type 1 study; implementation barriers; implementation evaluation; implementation facilitation; implementation facilitators; improved; innovation; intervention effect; motivational enhancement therapy; multimodality; novel; opioid tapering; pain-related disability; patient engagement; patient oriented; patient-level barriers; prescription opioid; primary care provider; primary endpoint; primary outcome; psychologic; response; secondary outcome; success; system-level barriers; tool; uptake; whole health

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.

背景：针对阿片类药物相关危害和支持非药物治疗的证据 (NPT) 对于慢性疼痛，VHA 优先考虑多模式疼痛治疗方法，包括证据- 基于 NPT。然而，《不扩散核武器条约》一直没有得到充分利用，退伍军人层面的障碍在很大程度上仍然存在 未解决。选项（使用非药物策略的疼痛管理选项）重点关注 通过以下方式克服退伍军人级别的 NPT 使用和遵守障碍：1) 帮助患者的决策援助 了解和比较 NPT 选项并找到最适合他们的目标和生活方式的 NPT，以及 2) 使用动机性访谈来培养自我效能感的教练，帮助退伍军人与他们的人讨论 NPT 提供者，并建立患者通过 NPT 控制疼痛的信心。 意义：OPTIONS 通过关注行为健康直接响应 HSR&D 的阿片类药物征集 以及退伍军人参与非药物治疗。 OPTIONS 还支持 2016 年综合版 《成瘾与康复法案》和许多退伍军人事务部指令都侧重于提高 NPT 的可用性。 创新/影响：尽管有越来越多的证据证明《不扩散核武器条约》的有效性，但明显缺乏研究 旨在克服患者层面使用 NPT 的障碍。这是阻碍疼痛管理的关键差距 以及减少对阿片类药物依赖的目标。 OPTIONS 是第一项使用量身定制的、以患者为中心的研究 解决患者接受和遵守 NPT 障碍的方法。因此，OPTIONS 提供 这是对 VA 全系统旨在促进《不扩散核武器条约》的努力的重要补充，并有助于确保 VA 对这些举措的大量投资可以增加 NPT 的使用并改善退伍军人的成果。 我们与 VA 疼痛管理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 教练来促进 OPTIONS 的实施（如果是） 积极尝试——进一步增强该提案的影响力。 具体目标： 目标 1：测试 OPTIONS 干预对疼痛干扰（主要结果）的影响 患有慢性疼痛的退伍军人。 目标 2：测试 OPTIONS 干预措施对 NPT 使用和次要结果（健康相关质量）的影响 生活、心理功能、患者激活）。 目标 3：确定实施选项干预的促进因素和障碍。 方法：这项混合 1 类研究将测试有效性，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被随机分配接受干预（为期 10 周） 使用动机性访谈和关于 NPT 的 OPTIONS 决策辅助进行辅导）或等待名单控制组。 我们将检查基线以及 3、6 和 9 个月的结果。在目标 3 中，我们将使用定性方法 通过对一部分干预措施的访谈来了解未来实施的促进因素和障碍 退伍军人和 PCP 的患者接受了 OPTIONS 干预。 实施/后续步骤：在取得积极结果之前，我们的下一步将是多站点混合 2 型 有效性实施试验，我们将评估实施情况，同时继续测试 效力。我们将与我们的运营合作伙伴合作，利用以下方式实施 OPTIONS 干预措施： 现有的整体健康教练，从而有助于确保可持续性。此外，目标 3 的发现， 该报告审查了实施的障碍和促进因素，将有助于指导后续步骤。