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

非药物疼痛治疗在安全有效地逐渐减少慢性疼痛中阿片类药物的作用

• 批准号: 10620195
• 负责人: WILLIAM C BECKER
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10620195
• 关键词: Address; Adverse event; American; Articulation; Benefits and Risks; Buprenorphine; COVID-19; COVID-19 impact; Caring; Centers for Disease Control and Prevention (U.S.); Cessation of life; Characteristics; Clinical; Combined Modality Therapy; Communities; Complementary Health; Data; Deimplementation; Dose; Dropout; Effectiveness; Electronic Health Record; Electronics; Emergency department visit; Equilibrium; Ethnic Origin; Evaluation; Evaluation Reports; Event; Exercise; Face; Feeling suicidal; Formulation; Funding; Gender; Goals; Guidelines; Health Services; Health Services Accessibility; Health Services Research; Healthcare Systems; Hospitalization; Institution; Integrative Medicine; Measures; Mental Health; Mental disorders; Methodology; Methods; Modality; Modeling; Opiate Addiction; Opioid; Outcome; Overdose; Pain; Pain intensity; Pain management; Patient-Centered Care; Patients; Pattern; Perception; Personal Satisfaction; Pharmacy facility; Physiological; Practice Management; Prevention Guidelines; Quasi-experiment; Race; Randomized, Controlled Trials; Recommendation; Recovery; Regimen; Research; Research Design; Retrospective cohort; Retrospective cohort study; Risk; Role; Safety; Sampling; Serious Adverse Event; Services; Site; Substance Addiction; Substance Use Disorder; Suicide attempt; Testing; Translations; United States Department of Veterans Affairs; Veterans; Veterans Health Administration; Withdrawal Symptom; Work; Yoga; addiction; adverse outcome; age effect; buprenorphine treatment; chiropracty; chronic pain; chronic pain management; cohort; comorbidity; compare effectiveness; data warehouse; design; effective therapy; effectiveness outcome; evidence base; experience; health service use; implementation study; improved; innovation; medication safety; milligram; morphine equivalent; mortality; multidisciplinary; multilevel analysis; multimodality; novel; opioid mortality; opioid overdose; opioid tapering; opioid therapy; opioid use; opioid use disorder; pharmacy benefit; physical conditioning; prescription opioid; scale up; secondary analysis; service uptake; service utilization; side effect; sociodemographics; substance use; symposium; treatment effect; treatment services; uptake; whole health

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.

背景：有证据表明长期阿片类药物治疗存在严重不良后果的风险和有限的益处 (LTOT) 已推动 VA 建议在福利不再有效时逐渐减少或终止 LTOT 然而，减少 LTOT 也可能带来危害。意义：该研究解决了一个问题。 迫切需要清楚地证明 LTOT 逐渐减少的风险，并要求具体的 VA 评估 非药物疼痛治疗，包括补充和综合健康服务 (NPM/CIH)。 该项目的目标是评估 NPM/CIH 使用在实现安全和临床意义方面的作用 减少患有慢性疼痛的退伍军人的 LTOT 治疗方案，与两个主要相关的结果发生变化。 整个医疗保健系统 (WHS) 和 COVID-19 的实施情况将受到评估。 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 转型 (OPCC&CT)，该研究将扩大正在进行的 NPM/CIH 评估的范围，包括 与药物依赖和成瘾相关的结果。 退伍军人管理局药物安全中心 (MedSAFE) 根据新的试点数据，我们的团队将成为其中之一 首先应用一种新方法来优化 LTOT 锥度的确定，以改进锥度分析 - 该研究将为解决多模式减量方法的临床指南提供信息。 具体目标是 (1) 描述 LTOT 退伍军人的 NPM/CIH 访问和利用情况， (2) 考虑实施 VHA 整体卫生保健系统和 COVID-19 的影响； 比较使用 LTOT 和不使用 NPM/CIH 的退伍军人逐渐减少阿片类药物的有效性和安全性 (3) 评估丁丙诺啡对 NPM/CIH 对结果影响的调节作用。 NPM/CIH 将与更高的有效性和安全性相关，并且丁丙诺啡的使用将 与 NPM/CIH 对这些结果的更积极影响相关。 方法：该项目将确定 2016 年至 2020 年期间约 200,000 人的回顾性队列 在 54 个 VA 机构中，退伍军人接受 ≥ 30 毫克吗啡当量日剂量 (MEDD) 的 LTOT。 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 将应用 VA 开发的新方法对 VHA 内和社区内的 NPM/CIH 进行评估。 MedSAFE 使用企业数据仓库内的 VHA 电子药房数据，我们将开发模型 使用准实验方法，退伍军人将被“分配”到目标期限内逐渐减少阿片类药物。 根据观察到的服务利用率进行 NPM/CIH 治疗或不治疗。 平衡由于非随机分配而导致的基线差异。在多水平模型中，阿片类药物逐渐减少的结果。 将被建模为 NPM/CIH 使用的函数 主要的逐渐减少有效性结果将是 退伍军人中处方阿片类药物剂量减少≥基线 mg MEDD 50% 的比例， 在没有加剧疼痛强度的情况下维持六个月以上，将测量逐渐减少的安全性。 经历任何严重不良事件 (SAE) 的退伍军人比例，允许逐渐减少所有值， 包括不逐渐减量和增加剂量 SAE 将包括住院、急诊室就诊、阿片类药物。 药物过量、新的精神健康障碍、新的阿片类药物或其他物质使用障碍、自杀企图以及所有 - 模型将评估丁丙诺啡治疗阿片类药物对 NPM/CIH 影响的调节作用。 逐渐减少和慢性疼痛的二级模型将评估 NPM/CIH 对 LTOT 相关侧的影响。 不同年龄、种族/民族和性别的 NPM/CIH 效果和差异 后续步骤/实施： 运营合作伙伴和退伍军人参与小组将指导结果的解释并促进 结果将为支持扩大规模的实施研究提供信息。 维持有效的疼痛管理实践并促进安全有效地减少阿片类药物。