Group-Based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care

慢性腰痛（cLBP）是在初级保健环境中治疗的最常见的疾病之一，但 许多患者的治疗仍然不令人满意。阿片类药物危机凸显了 用有效的治疗方法缓解患者的cLBP，包括循证的非药物方法。 正念对于治疗cLBP是有效的，但仍然没有得到充分利用，因为它没有被定期编织 进入门诊临床环境。基于正念的减压（MBSR）现在被推荐为 美国医师学会对cLBP的初始治疗。下一个必要的步骤是做一个务实的 临床试验（PCT），目的是告知决策者该计划如何在现实生活中发挥作用 临床环境及其对结果的影响。我们提出了一个名为“最佳”的计划的PCT （优化疼痛治疗在医疗环境中使用正念）。它将与三个 医疗保健系统（HCS）站点（Boston Medical Center，MA，UPMC，Pittsburgh，PA，and皮埃蒙特健康 服务，与北卡罗来纳州，查佩尔山大学合作）。我们的首要目标是确定 在通常的护理情况下，这种干预的影响。该项目的基本原理是告知关键 决策者如何将非药物治疗纳入常规护理，以及这种治疗的影响 关键成果的方案。UG 3阶段的具体目标如下：目标1：规划和测试 在前12个月的完整PCT之前，在3-HCS研究中心实施正念临床疼痛计划OPTIMUM， 项目的几个月。在合作实验室的指导下，将达到明确定义的里程碑 协调中心。UH 3阶段的具体目标是：目标2。为了整合和测试一个基于证据的 正念临床疼痛计划，OPTIMUM，用于初级保健环境中的cLBP患者。四- 将150名年龄≥ 18岁的cLBP患者随机分配至1）OPTIMUM（n=225）+ PCP治疗组 护理;或2）五氯苯酚产后护理（n=225）。主要假设：OPTIMUM中的患者将显著 与PCP尿道护理相比，在完成计划时以及6个月和12个月后减轻疼痛。 假设2：OPTIMUM患者的身体和心理状况将显着改善 与PCP产后护理相比，PCP产后护理在方案完成时以及6个月和12个月后发挥作用。 假设3：OPTIMUM组的患者不太可能开始，更可能减少或停止 cLBP的阿片类药物处方与PCP患者护理中的阿片类药物处方相比。目标3.评价使用 电子健康记录中记录的患者的医疗保健资源。假设：患者 OPTIMUM将减少急诊就诊、住院治疗、影像学检查（CT/MRI）， 比PCP常规护理更少的程序（注射，手术）。目标4。评价五氯苯酚并进行现场使用， 对OPTIMUM的满意度和集成度。在初级保健中提供团体正念疼痛计划 是创新的，我们希望它将提高质量，并与cLBP护理满意度。

Chronic low back pain (cLBP) is one of the most common conditions treated in the primary care setting, yet treatment remains unsatisfactory for many patients. The opioid crisis has underscored the urgency of alleviating patients' cLBP with effective therapies, including evidence-based nonpharmacologic approaches. Mindfulness is effective for the treatment of cLBP yet remains underutilized as it has not been regularly woven into the outpatient clinical setting. Mindfulness-based Stress Reduction (MBSR) is now recommended by the American College of Physicians for initial treatment of cLBP. The next necessary step is to do a pragmatic clinical trial (PCT) with the goal of informing decision makers how this program can work in a real-life clinical setting and its impact on outcomes. We propose a PCT of this program titled “OPTIMUM” (Optimizing Pain Treatment In Medical settings Using Mindfulness). It will be conducted with three health care system (HCS) sites (Boston Medical Center, MA, UPMC, Pittsburgh, PA, and Piedmont Health Services, in partnership with the University of North Carolina, Chapel Hill). Our primary goal is to determine the impact of this intervention under usual care circumstances. The rationale for this project is to inform key decision-makers how nonpharmacologic treatment can be integrated into routine care and the impact of this program on key outcomes. The specific aims UG3 Phase are the following: Aim 1: To plan and test a mindfulness clinical pain program, OPTIMUM, in the 3-HCS sites prior to the full PCT during the first 12- months of the project. Clearly defined milestones will be reached with guidance from the Collaboratory Coordinating Center. The specific aims UH3 Phase are: Aim 2. To integrate and test an evidence-based mindfulness clinical pain program, OPTIMUM, for patients with cLBP in the primary care setting. Four- hundred-fifty persons with cLBP ≥ 18 years of age will be randomized to 1) OPTIMUM (n=225) + PCP Usual Care; or 2) PCP Usual Care (n=225). Primary Hypothesis: patients in OPTIMUM will have significantly reduced pain at completion of the program and 6- and 12-months later, as compared to PCP Usual Care. Hypothesis 2: patients in OPTIMUM will have significantly improved physical and psychological function at completion of the program and 6- and 12-months later, as compared to PCP Usual Care. Hypothesis 3: patients in OPTIMUM will be less likely to start and more likely to reduce or stop an opioid prescription for cLBP as compared to those in PCP Usual Care. Aim 3. To evaluate use of healthcare resources by patients as documented in the electronic health record. Hypothesis: patients in OPTIMUM will have fewer emergency department visits, fewer hospitalizations, fewer imaging (CT/MRI), and fewer procedures (injections, surgery) than PCP usual care. Aim 4. To evaluate PCP and practice site use of, satisfaction with, and integration of OPTIMUM. Delivering a group mindfulness pain program in primary care is innovative and we expect it will increase the quality of, and satisfaction with cLBP care.