Role of Non-pharmacological Pain Treatments in Safe and Effective Opioid Tapering in Chronic Pain

背景：长期阿片类药物治疗的严重不良后果和有限益处的风险证据 (LTOT)推动退伍军人管理局建议LTOT缩减或在福利不再时停止使用 利大于弊。然而，LTOT缩减也可能带来危害风险。意义：这项研究针对的是 迫切需要清楚地展示LTOT缩减风险和具体的退伍军人事务部要求评估 非药物性疼痛治疗，包括补充和综合卫生服务(NPM/CIH)。这个 该项目的目标是评估NPM/CIH的使用在安全和临床上有意义的作用 为患有慢性疼痛的退伍军人减少LTOT方案。与两个主要因素相关的结果变化 将对各个时期--整个保健系统和新冠肺炎的实施情况--进行评估。 创新和影响：与以患者为中心的护理和文化办公室持续合作 关于转型(OPCC和CT)，这项研究将扩大正在进行的NPM/CIH评估的范围，包括 与物质依赖和成瘾有关的结果。与药房福利管理合作 服务的退伍军人管理局药物安全中心(MedSafe)，根据新的飞行员数据，我们的团队将成为 首先，应用一种新的方法来优化LTOT锥度的测定，以改进锥度的分析。 相关结果。这项研究将为解决多模式缩减方法的临床指南提供信息。 具体目标是：(1)用LTOT描述退伍军人获得和利用NPM/CIH的情况， 考虑到VHA全健康护理体系和新冠肺炎实施的影响；(2) 比较有无NPM/CIH的LTOT退伍军人使用阿片类药物的有效性和安全性；(3) 评估丁丙诺啡对NPM/CIH对预后的调节作用。我们假设使用 NPM/CIH将与更高的有效率和安全性相关，丁丙诺啡的使用将 NPM/CIH对这些结果的积极影响更大。 方法：该项目将确定2016-2020年间约200,000人的回顾队列 退伍军人在≥接受LTOT54个退伍军人医院的30毫克吗啡当量日剂量(MEDD)。 利用退伍军人健康管理局(VHA)电子健康记录数据，退伍军人对 将对VHA和社区内的NPM/CIH进行评估。应用退伍军人管理局开发的一种新方法 MedSafe使用公司数据仓库中的VHA电子药房数据，我们将开发模型 在目标期内减少阿片类药物的数量。使用准实验方法，退伍军人将被分配到 NPM/CIH治疗或不治疗取决于他们观察到的服务利用情况。倾向分数匹配将 平衡因非随机分配而产生的基线差异。在多水平模型中，阿片类药物逐渐减少的结果 将作为NPM/CIH使用的一个函数进行建模。缩减效力的主要结果将是 实现≥处方阿片类药物剂量减少基线mg Medd的50%的退伍军人比例 在疼痛强度没有恶化的情况下维持六个月以上。逐渐减少的安全性将以 退伍军人经历任何严重不良事件(SAE)的比例，允许缩减所有价值， 包括没有缩减和剂量增加。SAE将包括住院、急诊科就诊、阿片类药物 吸毒过量，新的精神健康障碍，新的阿片类药物或其他物质使用障碍，自杀未遂，以及所有- 导致死亡。模型将评估丁丙诺啡治疗阿片类药物对NPM/CIH影响的缓和 逐渐减少和治疗慢性疼痛。二级模型将评估NPM/CIH对LTOT相关方面的影响 年龄、种族/民族和性别对NPM/CIH效应的影响和差异。后续步骤/实施： 业务合作伙伴和经验丰富的参与小组将指导对结果的解释并促进 传播和翻译到实践。结果将为实施研究提供信息，以支持扩大规模 维持有效的疼痛管理做法，促进安全有效的阿片类药物减少。

Background: Evidence of risks for serious adverse outcomes and limited benefit of long-term opioid therapy (LTOT) have driven VA recommendations for LTOT tapering or discontinuation when benefits no longer outweigh harms. However, LTOT tapering may also pose risks of harm. Significance: The study addresses a critical need for clear demonstration of LTOT tapering risks and a specific VA call for evaluation of nonpharmacological pain treatments including complementary and integrative health services (NPM/CIH). The goals of this project are to assess the role of NPM/CIH use in effecting safe and clinically meaningful reductions in LTOT regimens for Veterans with chronic pain. Changes in outcomes associated with two major periods -- the implementation of the Whole Health System of care (WHS) and COVID-19 – will be assessed. Innovation and Impact: In ongoing partnership with the Office of Patient-Centered Care and Cultural Transformation (OPCC&CT), the study will broaden the scope of ongoing NPM/CIH evaluation to include outcomes related to substance dependence and addiction. Partnering with Pharmacy Benefits Management Services’ VA Center for Medication Safety (MedSAFE), informed by new pilot data, our team will be one of the first to apply a novel method to optimize determination of LTOT tapering to improve analyses of tapering- related outcomes. The study will inform clinical guidelines addressing multimodal approaches to tapering. Specific Aims are to (1) Characterize NPM/CIH access and utilization among Veterans with LTOT, considering the impact of implementation of the VHA Whole Health System of Care and COVID-19; (2) Compare the effectiveness and safety of opioid tapering for Veterans with LTOT with and without NPM/CIH; (3) Assess the moderating effect of buprenorphine on NPM/CIH effects on outcomes. We hypothesize that use of NPM/CIH will be associated with higher rates of effectiveness and safety, and that use of buprenorphine will be associated with more positive effects of NPM/CIH on these outcomes. Methodology: The project will identify a retrospective cohort between 2016-2020 of approximately 200,000 Veterans receiving LTOT at ≥ 30 mg morphine equivalent daily dose (MEDD) across 54 VA facilities. Leveraging Veterans Health Administration (VHA) electronic health record data, Veterans’ utilization of NPM/CIH within VHA and in the community will be assessed. Applying a novel method developed by VA MedSAFE using VHA electronic pharmacy data within the Corporate Data Warehouse, we will develop models of opioid tapering within the target period. Using quasi-experimental methods, Veterans will be “assigned” to NPM/CIH treatment or no treatment based on their observed service utilization. Propensity score matching will balance baseline differences due to nonrandom assignment. In multilevel models, opioid tapering outcomes will be modeled as a function of NPM/CIH use. The primary tapering effectiveness outcome will be the proportion of Veterans achieving a reduction in prescribed opioid dose of ≥50% of baseline mg MEDD, maintained over six months in the absence of worsened pain intensity. Tapering safety will be measured as the proportion of Veterans experiencing any serious adverse event (SAE), allowing tapering to take all values, including no taper and dose increases. SAE will include hospitalization, emergency department visit, opioid overdose, new mental health disorder, new opioid or other substance use disorder, suicide attempt, and all- cause mortality. Models will assess moderation of NPM/CIH effects by buprenorphine treatment for opioid tapering and for chronic pain. Secondary models will assess the effect of NPM/CIH on LTOT-related side effects and differences in NPM/CIH effect by age, race/ethnicity and gender. Next Steps/Implementation: Operational partners and a Veteran engagement panel will guide interpretation of results and promote dissemination and translation to practice. Results will inform an implementation study to support the scale-up and sustainment of effective practices for pain management and facilitating safe and effective opioid reduction.