Chronic Pain Management and Patient-Centered Outcomes Following Discontinuation of Long-Term Opioid Therapy

停止长期阿片类药物治疗后的慢性疼痛管理和以患者为中心的结果

• 批准号: 10308452
• 负责人: Travis Ian Lovejoy
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-11-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10308452
• 关键词: Accounting; Acute; Address; Administrator; Attention; Caring; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinical; Communities; Community Networks; Data; Data Analyses; Dose; Electronic Health Record; Enrollment; Ethnic Origin; Feeling suicidal; Female; Gender; Goals; Guidelines; Heroin; Hospitals; Intervention; Interview; Mental Health; Methodology; Methods; Modality; Opioid; Outcome; Pain; Pain Clinics; Pain intensity; Pain interference; Pain management; Patient Monitoring; Patient-Centered Care; Patient-Focused Outcomes; Patients; Pharmacy facility; Population; Primary Health Care; Process; Prospective cohort study; Qualitative Methods; Quality of life; Race; Reporting; Resources; Safety; Sampling; Secondary pain; Severities; Structure; Suicide attempt; Surveys; Symptoms; Telephone; Testing; Time; Veterans; Volition; base; chronic pain management; chronic pain patient; cohort; design; empowered; ethnic minority; evidence base; experience; follow-up; health care service utilization; health disparity; non-cancer chronic pain; non-opioid analgesic; operation; opioid epidemic; opioid therapy; overdose death; pain outcome; pain patient; prescription opioid; racial and ethnic; risk mitigation; substance use; systematic review; trend

Nearly 900,000 Veterans were dispensed opioid medication at the prescribing peak in 2012, with rates of opioid prescribing in VA subsequently declining year-over-year to fewer than 700,000 Veterans dispensed opioid medication in 2016. These downward trends are likely to continue with more widespread implementation of the VA Opioid Safety Initiative, additional efforts at local VA hospitals to enhance opioid risk mitigation and safe opioid prescribing practices, and recently released CDC and VA/DoD opioid prescribing guidelines that discourage long-term opioid therapy for chronic non-cancer pain. Despite steady rates of opioid discontinuation in VA, little is known about consequences—both positive and negative—of opioid discontinuation. The objectives of this study are to characterize patients’ experiences with the opioid discontinuation process, identify ways patients subsequently manage their pain through the use of VA and non-VA resources, and examine patient-centered outcomes such as quality of life, pain, substance use, and mental health symptom severity following opioid discontinuation. This prospective cohort study will enroll 1,144 VA patients randomly selected from the population of VA patients prescribed long-term opioid therapy. All patients will complete 5 mailed or online survey assessments at baseline, 6-, 12-, 18-, and 24-month follow-up that assess quality of life, pain, substance use, and mental health symptoms. Additional clinical and pharmacy data will be extracted from patients’ VA electronic health record. We will monitor patients in the cohort for reductions in opioid dose and complete opioid discontinuation. Patients who discontinue opioid therapy will complete an additional survey to assess acute patient outcomes following opioid discontinuation. A subset of 40 patients who discontinue opioid therapy will participate in semi-structured interviews over the telephone immediately following discontinuation, as well as 6- and 12 months post-discontinuation. Interviews will ascertain patients’ experiences with the opioid discontinuation process, pain treatment approaches utilized within and external to VA, and patient outcomes following discontinuation. This study has three specific aims: (1) compare acute (immediate), intermediate (6-month), and long-term (12-month) quality of life and pain outcomes between patients who discontinue versus those who remain on long-term opioid therapy (LTOT), (2) test the moderating effect of gender and race/ethnicity on changes in quality of life and pain outcomes between patients who discontinue versus those who remain on LTOT, and (3) use qualitative methods to augment quantitative findings on patient quality of life and pain outcomes, identify patient experiences with the opioid discontinuation process, and characterize the impact of discontinuation on patient-clinician relationships. The integration of results from quantitative and qualitative data analyses will characterize patient experiences with, and outcomes following, opioid discontinuation. This study is both timely and highly relevant to current national VA priority goals of (1) Pain and Use of Opioids and (2) Care in Community Networks. Specifically, this study will provide VA operations administrators, hospital executives, and clinicians with information that characterizes opioid discontinuation from patients’ perspectives. These perspectives can inform best practices for discontinuing opioid therapy, when clinically indicated, while simultaneously mitigating negative consequences of discontinuation and engaging and empowering patients to manage chronic pain with evidence-based non- opioid treatment modalities available within VA and in the community.

在2012年的处方高峰期，近90万退伍军人被分配阿片类药物， 弗吉尼亚州的阿片类药物处方随后逐年下降，分配给不到70万名退伍军人 2016年的阿片类药物。随着更广泛的实施， VA阿片类药物安全倡议，在当地VA医院加强阿片类药物风险缓解的额外努力， 安全的阿片类药物处方实践，以及最近发布的CDC和VA/DoD阿片类药物处方指南， 不鼓励长期阿片类药物治疗慢性非癌症疼痛。尽管阿片类药物停药率稳定 在VA中，对阿片类药物停药的积极和消极后果知之甚少。的 本研究的目的是描述患者在阿片类药物停药过程中的经历， 确定患者随后通过使用VA和非VA资源管理疼痛的方法，以及 检查以患者为中心的结果，如生活质量、疼痛、物质使用和心理健康症状 阿片类药物停药后的严重程度。这项前瞻性队列研究将随机招募1，144名VA患者 选自规定长期阿片类药物治疗的VA患者人群。所有患者将完成5 在基线、6个月、12个月、18个月和24个月随访时进行邮寄或在线调查评估， 生活、疼痛、物质使用和精神健康症状。将提取其他临床和药学数据 从退伍军人管理局的电子健康记录中我们将监测队列中的患者是否减少阿片类药物剂量 并完全停用阿片类药物停止阿片类药物治疗的患者将完成额外的 评估阿片类药物停药后急性患者结局的调查。40名患者的一个子集， 停止阿片类药物治疗将立即通过电话参加半结构化访谈 停药后以及停药后6个月和12个月。访谈将确定患者的 阿片类药物停药过程的经验， VA和停药后的患者结局。本研究有三个具体目的：（1）比较急性 （即刻）、中期（6个月）和长期（12个月）生活质量和疼痛结局 停止治疗的患者与继续接受长期阿片类药物治疗（LTOT）的患者，（2）测试 性别和人种/种族对以下患者的生活质量和疼痛结局变化的影响 停止与那些谁仍然在LTOT，（3）使用定性方法，以增加定量 患者生活质量和疼痛结局的结果，确定阿片类药物停药的患者经历 过程，并描述停药对患者-临床医生关系的影响。的整合 定量和定性数据分析的结果将描述患者的经验和结局 阿片类药物停药后。这项研究是及时和高度相关的当前国家退伍军人事务优先事项 目标是（1）疼痛和阿片类药物的使用和（2）社区网络中的护理。具体而言，本研究将提供 VA运营管理人员，医院管理人员和临床医生，具有阿片类药物特征的信息 从患者的角度出发。这些观点可以为中断的最佳实践提供信息 阿片类药物治疗，当有临床指征时，同时减轻 停止治疗，让患者参与并授权患者使用循证非 阿片类药物治疗方式可在VA和社区。