Assessing the Safety and Effectiveness of Opioid Tapering in Large Health Systems

评估大型卫生系统中阿片类药物逐渐减少的安全性和有效性

• 批准号: 10089434
• 负责人: Ingrid A Binswanger
• 金额: $ 54.2万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-15 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10089434
• 关键词: Address; Adopted; Adverse effects; Affect; Age; Award; Behavior; Centers for Disease Control and Prevention (U.S.); Chronic; Clinical; Colorado; Complex; Data; Depression and Suicide; Development; Dose; Effectiveness; Electronic Health Record; Ethnic Origin; Fentanyl; Fright; Goals; Guidelines; Health Services; Health behavior; Health system; Heroin; Individual; Information Systems; Lead; Link; Longitudinal cohort; Longitudinal cohort study; Medical; Medical Records; Mental Depression; Mental disorders; Methodology; Methods; Modeling; Opioid; Opioid Analgesics; Outcome; Overdose; Pain; Pain management; Pathway interactions; Patient Outcomes Assessments; Patients; Pattern; Pharmaceutical Preparations; Physicians; Policies; Provider; Race; Research; Risk; Risk Estimate; Risk Factors; Safety; Sample Size; Substance Use Disorder; Suicide; Techniques; United States; Wisconsin; Withdrawal; base; chronic pain; chronic pain patient; cohort; data resource; effectiveness evaluation; epidemiology study; follow-up; health care service utilization; illicit opioid; innovation; novel; opioid epidemic; opioid mortality; opioid overdose; opioid tapering; opioid therapy; opioid use disorder; overdose death; overdose risk; prescription opioid; provider behavior; provider factors; response; rural area; sex; sociodemographics; substance use; suicidal risk; systematic review; urban area

PROJECT ABSTRACT The United States is amidst a rapidly evolving opioid epidemic, with more than 200,000 deaths from opioid pain reliever overdoses since 1999. In 2016, the Centers for Disease Control and Prevention issued guidelines on the management of opioid therapy in chronic pain. These guidelines emphasized tapering opioids among individuals prescribed high-dose opioid therapy or with other overdose risk factors. While physicians are increasingly reducing or discontinuing (tapering) patients prescribed chronic opioid therapy, evidence to support the effectiveness and safety of tapering practices is lacking. While tapering opioids represents a reasonable approach to reduce the risk of overdose, there are also concerns that tapering opioids may lead to increased pain and withdrawal, prompting some individuals to seek illicit opioids such as heroin, paradoxically increasing their risk for overdose. The overall goal of this project is to conduct a longitudinal cohort study to determine the effectiveness and safety of opioid tapering in large health systems. We will leverage a data system (Pathways to Opioid Safety Datalink [POSD]) that contains linked data on more than 2.5 million people in rural and urban areas in Colorado and Wisconsin. Using the POSD data system, we will examine opioid tapering practices in a cohort of approximately 48,000 patients prescribed chronic opioid therapy from 2012 to 2020. We will employ novel analytic techniques to identify distinct tapering practices, such as gradual dose reduction, rapid dose reduction, dose discontinuation followed by re-initiation, and sustained dose discontinuation. We will then determine which patient and provider factors and behaviors are associated with opioid tapering. In the cohort, effectiveness and safety will be examined by comparing clinically important outcomes across tapering practices. Outcomes will include overdose, suicide, opioid use disorder, and health care utilization for pain and withdrawal. Lastly, we will develop and apply novel methods to minimize bias from loss to follow-up and misclassification of exposure and outcomes, including quantitative bias analysis, probabilistic bias analysis, and propensity scores. Our findings will have the potential to influence national clinical guidelines on opioid management. Our proposed research approach also represents a new paradigm for how to rigorously assess important opioid prescribing and substance use outcomes using complex health services data.

项目摘要 美国正处于阿片类药物流行迅速演变的时期，有20多万人死于阿片类药物 自1999年以来止痛药过量。2016年，美国疾病控制和预防中心发布了指导方针 关于阿片类药物治疗慢性疼痛的管理。这些指南强调减少阿片类药物在 开出大剂量阿片类药物治疗或有其他过量风险因素的个人。当医生们 越来越少或停止(逐渐减少)患者开出的慢性阿片类药物治疗，证据 缺乏对缩减做法的有效性和安全性的支持。而逐渐减少阿片类药物代表着 虽然采取合理的方法来减少过量用药的风险，但也有人担心逐渐减少阿片类药物可能会导致 疼痛和戒断增加，促使一些人寻求非法阿片类药物，如海洛因，这是自相矛盾的 增加了他们服药过量的风险。 该项目的总体目标是进行纵向队列研究，以确定有效性和 阿片类药物在大型卫生系统中逐渐减少的安全性。我们将利用数据系统(阿片类药物安全途径 Datalink[POSD])，其中包含年农村和城市地区250多万人的关联数据 科罗拉多州和威斯康星州。使用POSD数据系统，我们将审查一组阿片类药物逐渐减少的做法 从2012年到2020年，大约48,000名患者使用了慢性阿片类药物。我们将采用小说 分析技术，以确定不同的缩减做法，如逐步减少剂量、快速减少剂量、 停药后重新开始，以及持续停药。然后我们将确定 哪些患者和提供者的因素和行为与阿片类药物的逐渐减少有关。在队列中， 有效性和安全性将通过比较临床上重要的结果来检验。 练习。结果将包括服药过量、自杀、阿片类药物使用障碍以及医疗保健对疼痛和 戒烟。最后，我们将开发和应用新的方法，以最大限度地减少从损失到后续和 对暴露和结果的错误分类，包括定量偏差分析、概率偏差分析、 和倾向性得分。 我们的发现将有可能影响国家阿片类药物管理的临床指南。我们的 拟议的研究方法也代表了如何严格评估重要阿片类药物的新范式 使用复杂的卫生服务数据开处方和使用药物的结果。