Cohort Study of Opioids, Pain, and Safety in an era of Changing Policy (COPING)

政策变化时代的阿片类药物、疼痛和安全性队列研究 (COPING)

• 批准号: 9106796
• 负责人: PHILLIP O COFFIN
• 金额: $ 47.94万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9106796
• 关键词: Address; Adult; Affect; Alcohol consumption; Alcohol or Other Drugs use; Behavior assessment; Behavioral; Cause of Death; Cessation of life; Characteristics; Chronic; Clinic; Clinical; Cocaine; Cohort Studies; Comorbidity; Computer Assisted; Data; Dose-Limiting; Drug Monitoring; Drug usage; Electronic Health Record; Enrollment; Epidemic; Equation; Event; Frequencies; Funding; Goals; HIV; Hair; Health; Health Care Quality Indicators; Housing; Hyperalgesia; Incidence; Injury; Intervention; Interview; Lead; Life; Logistics; Measures; Medical; Methamphetamine; Methods; Modeling; Morphine; Naloxone; National Institute of Drug Abuse; Nociception; Opiate Addiction; Opioid; Outcome; Overdose; Pain; Pain Threshold; Pain management; Participant; Pathway interactions; Patients; Pattern; Persons; Pharmaceutical Preparations; Policies; Population; Prevention; Primary Health Care; Probability; Public Health; Quality of Care; Recording of previous events; Recruitment Activity; Registries; Research Personnel; Risk; Risk Factors; Safety; Sampling; San Francisco; Site; Source; Structural Models; Substance Use Disorder; Testing; Time; Toxicology; Treatment outcome; United States; United States National Institutes of Health; Urine; Venous blood sampling; Visit; Weight; Whole Blood; Work; base; cohort; design; experience; follow-up; functional status; milligram; mortality; non-cancer pain; opioid use; patient registry; prescription opioid; programs; public health relevance; public health research; repository; research clinical testing; symposium; trend

 DESCRIPTION (provided by applicant): We propose a time-sensitive cohort study of patients receiving opioid therapy for chronic non-cancer pain (CNCP) in the setting of shifting opioid prescribing policies. The United States, after decades of aggressive prescribing of opioids for CNCP, is now undergoing changes in prescribing policy and practice that is expected to reduce access to opioids for many patients. The primary care clinics of the San Francisco Health Network (SFHN), a network of integrated clinics managed by San Francisco's Department of Public Health (SFDPH), and local payers are also initiating tight restrictions on opioid prescribing in 2015. These changes include dose limits, restrictions on prescribing to persons with substance use disorders (SUDs), and required urine testing, and checks of the prescription drug monitoring program (PDMP). Many of these changes are designed to reduce diversion and are expected to lead to termination of opioid therapy for many patients. The impact of these changes on those already reliant upon opioids is unknown, although anecdotal evidence suggests that some patients initiate or resume illicit opioid use as prescribed opioids are terminated. In addition, there is little understanding of the rate, risk factors and event-level characteristics of opioid overdose among patients receiving opioids for pain. To address these major gaps in public health research, we will establish the Cohort study of Opioids, Pain and safety IN an era of chanGing policy (COPING), which will document changes in pain, functional status, prescribed opioid use and illicit substance use in the setting of shifting availability of prescribed opioids and identify opioid overdose patterns and risks in a population prescribed prescription opioids. We will recruit 400 patients prescribed ≥30 morphine equivalent milligrams of opioids daily for chronic, non-cancer pain, including at least 100 actively using illicit opioid, cocaine or methamphetamine and at least 100 living with HIV, from the SFHN registry of patients on chronic opioids for pain (Pain Management Registry, or "PMR", N=2,879), including patients whose opioids were recently discontinued. COPING participants will be seen every 6 months for phlebotomy; behavioral assessments on opioids, alcohol and drug use, pain control, and overdose events (Aim 1), and HIV treatment outcomes (Aim 4); and clinical evaluations for functional status (Aim 2). Biannual reviews of medical charts and administrative data will be conducted to evaluate incidence of major medical events (Aim 3). We will use generalized estimating equation (GEE) linear, logistic, and multinomial models to estimate and compare trends in behavioral and clinical outcomes and functional status, to prescribed opioids (continued versus reduced/lost access), and overall. We will assess incidence rates of opioid overdose using person-time methods and marginal structural models with stabilized inverse probability of treatment weights to estimate exposure effects for cases with time-dependent confounders that are affected by previous exposures as well as exposures that are affected by previous overdose events.

 描述（由适用提供）：我们提出了接受阿片类非癌症疼痛（CNCP）接受阿片类药物治疗的患者的时间敏感队列研究，以在不断变化的阿片类药物开处方政策的情况下进行。经过数十年来为CNCP的阿片类药物的积极开处方，美国现在正在经历规定政策和实践的变化，预计将减少许多患者获得阿片类药物的机会。旧金山卫生网络（SFHN）的初级保健诊所是由旧金山公共卫生部（SFDPH）管理的综合诊所网络（SFDPH），以及当地付款人以及对阿片类药物处方的严格限制。这些变化是对剂量限制的阿片类药物的严格限制。限制了对药物的使用量的限制。 （PDMP）。这些变化中的许多变化旨在减少转移，并有望导致许多患者终止阿片类药物疗法。这些变化对已经相关的阿片类药物的变化的影响尚不清楚，尽管轶事证据表明，某些患者终止了某些患者启动或恢复非法阿片类药物的使用。此外，对接受阿片类药物疼痛的患者中阿片类药物过量的速率，危险因素和事件级特征几乎没有理解。 To address These major gaps in public health research, we will establish the Cohort study of Opioids, Pain and safety IN an era of chanGing policy (COPING), which will document changes in pain, functional status, prescribed opioid use and illicit substance use in the setting of shifting availability of prescribed opioids and identify opioids overdose patterns and risks in a population prescribed prescription opioids.我们将每天招募400名在慢性，非癌症疼痛的阿片类药物≥30毫克的患者，包括至少100例使用非法阿片类药物，可卡因或甲基苯丙胺的非法药物，至少100例HIV和艾滋病毒，患者的疼痛患者对疼痛的患者进行了疼痛（或疼痛）（或疼痛）的疼痛（或疼痛）（或疼痛）（包括疼痛）的疼痛（或包括疼痛）（或）n.99。阿片类药物最近停产。应对参与者每6个月进行一次静脉切开术；对阿片类药物，酒精和药物使用，疼痛控制和过量事件（AIM 1）和HIV治疗结果的行为评估（AIM 4）；和功能状态的临床评估（AIM 2）。将对医疗图表和行政数据进行双年度审查，以评估重大医疗事件的发生率（AIM 3）。我们将使用广义估计方程（GEE）线性，逻辑和多项式模型来估计和比较行为和临床结果和功能状态的趋势，以开处方的阿片类药物（持续/降低/丢失的访问）和整体。我们将使用人员时间方法和边际结构模型评估阿片类药物过量的发生率，其治疗权重的稳定逆概率可以估计受到以前暴露影响的时间依赖性混杂因素的暴露效果，以及受到先前过量事件影响的暴露。