Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy - Yale Resource Center (MIRHIQL-YRC)

多层次干预措施可减少长期阿片类药物治疗患者的伤害并提高其生活质量 - 耶鲁大学资源中心 (MIRHIQL-YRC)

• 批准号: 10722768
• 负责人: WILLIAM C BECKER
• 金额: $ 462.63万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722768
• 关键词: Address; Adult; Adverse effects; American; Award; Behavior; Benefits and Risks; Bioethics; Biometry; Caring; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinic; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Cohort Studies; Collaborations; Communities; Companions; Complex; Consensus; Delphi Study; Dose; Elements; Feeling; Goals; Guidelines; Harm Reduction; Helping to End Addiction Long-term; Individual; Intervention; Intervention Trial; Knowledge; Leadership; Left; Long-Term Effects; Measurement; Methods; Modeling; Morbidity - disease rate; Opioid; Outcome; Pain; Pain Clinics; Pain management; Pain quality; Patient Care; Patients; Persons; Population; Positioning Attribute; Prospective, cohort study; Provider; Psychometrics; Public Health; Publishing; Qualifying; Quality of Care; Quality of life; Randomized; Recommendation; Recording of previous events; Reporting; Research; Resource Sharing; Resources; Risk; Risk Assessment; Screening procedure; Structure; Syndrome; Time; Translating; Veterans; Vulnerable Populations; addiction; adverse outcome; associated symptom; chronic pain; chronic pain management; clinical decision-making; clinical practice; daily functioning; data harmonization; early experience; experience; high risk; implementation trial; improved; innovation; mortality; multidisciplinary; non-opioid analgesic; novel; novel diagnostics; opioid tapering; opioid therapy; opioid use disorder; opioid withdrawal; pain relief; pain self-management; patient oriented; patient population; prescription opioid; prescription opioid addiction; screening; skills; tool

Even after significant reductions in long-term opioid therapy (LTOT) prescribing for chronic pain nationally, approximately 13 million US adults receive LTOT, putting them at risk for an array of harms often without adequate benefit. Due to the often unfavorable risk-benefit profile of LTOT, current consensus guidelines promote 1) continuous re-assessment of risk and benefit of LTOT and 2) reduction or discontinuation of LTOT while supporting pain self-management strategies and non-opioid pain care when benefit no longer outweighs harm. However, the guidelines lack crucial details--such as how to assess risk vs. benefit--hampering quality improvement efforts. Clinical research has been slowed by lack of consensus related to important questions such as: what is the threshold for determining that harm outweighs benefit in LTOT?, Should there be a new diagnostic entity to characterize the clinical scenario of harm outweighing benefit?, and, if so, What are its distinguishing characteristics? These research and clinical gaps translate into potentially poor quality pain care for patients on LTOT, including low efficacy and heightened risk in a vulnerable population. In accordance with RFA-DA-23-042, we propose the establishment of the Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy – Yale Resource Center (MIRHIQL-YRC) to address the national opioid public health crisis via a focus on the oft-overlooked population of patients on LTOT for whom risk may outweigh benefit but who do not have opioid use disorder. We propose an integrated, multi- level structure of the MIRHIQL-YRC modeled after our high-functioning IMPOWR-YOU Research Center, with a Community Steering Committee (CSC) at the hub and several smaller, agile workgroups focusing on specific tasks but moving forward in a highly inter-related fashion. The CSC's impact will be bolstered by the presence of partners historically left out of consensus-building projects: persons with lived experience and frontline clinicians, groups for whom it is crucial the tools and other products developed are patient-centered, non- stigmatizing, feasible and practical. Via this structure, the MIRHIQL-YRC, governed by the CSC, will pursue four objectives: (1) Facilitating, through a variety of mechanisms detailed herein, the successful execution of the companion MIRHIQL network R01 clinical trials; (2) Creating a risk-benefit decision tool to assist providers in determining when opioids should be continued as prescribed, tapered, or tapered and discontinued; (3) Creating a clinical definition, identifying associated symptoms/behaviors, and generating a screening assessment for individuals on LTOT for whom harms outweigh the benefits; and (4) Validating the clinical definition, associated symptoms/behaviors, and screening assessment in an independent prospective cohort study. Our multi-disciplinary team with a long track record of successful collaboration and deep and broad expertise in chronic pain and opioid management is exceptionally well-positioned to meet these objectives.

即使在全国范围内用于治疗慢性疼痛的长期阿片类药物治疗（LTOT）大幅减少之后， 大约 1300 万美国成年人接受了 LTOT，他们面临着遭受一系列伤害的风险，而这些伤害往往没有得到 由于 LTOT 的风险收益状况通常不利，目前的共识指南 促进 1) 持续重新评估 LTOT 的风险和效益，以及 2) 减少或终止 LTOT 同时在益处不再大于时支持疼痛自我管理策略和非阿片类疼痛护理 然而，该指南缺乏关键细节，例如如何评估风险与收益，从而影响了质量。 由于缺乏与重要问题相关的共识，临床研究的进展已经放缓。 例如：确定 LTOT 弊大于利的阈值是多少？、是否应该有新的 诊断实体来描述危害大于益处的临床情况？如果是的话，它是什么 这些研究和临床差距可能导致疼痛护理质量低下？ 对于接受 LTOT 的患者，包括弱势群体的低疗效和沉重的风险。 RFA-DA-23-042，我们建议建立多层次干预措施以减少危害和改善 长期阿片类药物治疗患者的生活质量 – 耶鲁大学资源中心 (MIRHIQL-YRC) 解决 通过关注经常被忽视的 LTOT 患者群体来应对全国阿片类药物公共卫生危机 对于那些风险可能大于益处但没有阿片类药物使用障碍的人，我们提出了一种综合的、多方面的治疗方案。 MIRHIQL-YRC 的层次结构以我们的高功能 IMPOWR-YOU 研究中心为模型， 位于中心的社区指导委员会 (CSC) 和几个专注于特定领域的较小的敏捷工作组 任务，但以高度相互关联的方式向前推进 CSC 的影响力将因存在而得到增强。 历史上被排除在建立共识项目之外的合作伙伴：具有生活经验和前线人员 战士，对他们来说至关重要的是开发的工具和其他产品以患者为中心，非 通过这种结构，由 CSC 管理的 MIRHIQL-YRC 将追求无耻的、可行的和实用的。 四个目标： (1) 通过本文详述的各种机制，促进成功执行 配套的 MIRHIQL 网络 R01 临床试验；(2) 创建风险收益决策工具来协助提供者 确定何时应按处方继续使用阿片类药物、逐渐减少或逐渐减少并停用 (3) 创建临床定义，识别相关症状/行为，并进行筛查 对 LTOT 弊大于利的个人进行评估；以及 (4) 验证临床； 独立前瞻性队列中的定义、相关症状/行为和筛查评估 我们的多学科团队拥有长期的成功合作记录以及深入而广泛的研究。 慢性疼痛和阿片类药物管理方面的专业知识非常适合实现这些目标。