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.

即使在全国范围内长期阿片类药物治疗（LTOT）处方大幅减少后， 大约有1300万美国成年人接受LTOT，使他们面临一系列伤害的风险， 足够的利益。由于LTOT的风险-获益特征通常不利，目前的共识指南 促进1）持续重新评估LTOT的风险和获益，2）减少或停止LTOT 同时支持疼痛自我管理策略和非阿片类药物疼痛护理，当受益不再超过 伤害然而，该指南缺乏关键的细节-例如如何评估风险与收益-妨碍质量 改进的努力。临床研究由于在重要问题上缺乏共识而进展缓慢 例如：在长期目标转移中，确定损害超过益处的阈值是多少？如果有一个新的 诊断实体来表征伤害超过受益的临床情况，如果是的话， 区别特征？这些研究和临床差距转化为潜在的低质量疼痛护理 对于LTOT患者，包括在弱势人群中疗效低和风险增加。根据 RFA-DA-23-042，我们建议建立多水平干预措施，以减少伤害并改善 长期阿片类药物治疗患者的生活质量-耶鲁资源中心（MIRHIQL-YRC） 通过关注经常被忽视的LTOT患者人群， 风险可能超过受益，但没有阿片类药物使用障碍的人。我们提出了一个综合的、多方面的、 MIRHIQL-YRC的层次结构以我们高功能的IMPOWR-YOU研究中心为模型， 一个位于中心的社区指导委员会（CSC）和几个较小的敏捷工作组，专注于具体的 任务，但在一个高度相互关联的方式前进。CSC的影响力将得到以下因素的支持： 在历史上被排除在建立共识项目之外的伙伴：具有生活经验和第一线的人 临床医生，对他们来说至关重要的是开发的工具和其他产品是以患者为中心的，非 污名化，可行和实用。通过这一结构，由CSC管理的MIRHIQL-YRC将继续 四个目标：（1）通过本文详述的各种机制，促进成功执行 伴随的MIRHIQL网络R 01临床试验;（2）创建风险受益决策工具，以帮助提供者 确定阿片类药物何时应继续按规定、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，并生成筛选 对LTOT患者的评估，其危害大于受益;以及（4）验证临床 独立前瞻性队列的定义、相关症状/行为和筛选评估 study.我们的多学科团队拥有长期的成功合作记录， 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。