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

2012年，近90万退伍军人在处方高峰期分配了阿片类药物， 退伍军人退伍军人的阿片类药物处方随后逐年下降，不到70万人 2016年的阿片类药物。随着更广泛的实施，这些下降的趋势可能会继续下去 关于退伍军人事务部阿片类药物安全倡议，当地退伍军人事务部医院为加强阿片类药物风险缓解和 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 不鼓励对慢性非癌症疼痛进行长期阿片类药物治疗。尽管阿片类药物的停用率保持稳定 在退伍军人事务部，人们对阿片类药物停用的后果--无论是积极的还是消极的--知之甚少。这个 这项研究的目的是描述患者在阿片类药物停用过程中的经历， 确定患者随后通过使用VA和非VA资源来管理其疼痛的方式，以及 检查以患者为中心的结果，如生活质量、疼痛、药物使用和精神健康症状 阿片类药物停用后的严重程度。这项前瞻性队列研究将随机招募1144名VA患者 从人群中挑选出长期服用阿片类药物的VA患者。所有患者将完成5项 在基线、6个月、12个月、18个月和24个月的跟踪期间进行邮寄或在线调查评估，以评估 生命、疼痛、药物使用和精神健康症状。将提取更多的临床和药学数据 从患者的退伍军人管理局电子健康记录中。我们将监测队列中的患者阿片类药物剂量的减少 以及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 评估阿片类药物停用后急性患者预后的调查。一个由40名患者组成的子集 停止阿片类药物治疗将立即通过电话参加半结构化采访 停产后，以及停产后6个月和12个月。面谈将确定患者的 阿片类药物停用过程的经验，内外使用的疼痛治疗方法 VA，以及停药后的患者结局。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)的生活质量和疼痛结果 停止治疗的患者与继续长期接受阿片类药物治疗(LTOT)的患者，(2)测试缓和 性别和种族/民族对患者生活质量和疼痛结局变化的影响 停止与那些继续使用LTOT的人，以及(3)使用定性方法来增加数量 关于患者生活质量和疼痛结果的调查结果，确定患者停用阿片类药物的经历 过程，并描述了停药对患者-临床医生关系的影响。整合了 定量和定性数据分析的结果将表征患者的体验和结果 紧随其后的是阿片类药物停用。这项研究既及时，又与当前的国家退伍军人管理局优先事项高度相关 目标(1)疼痛和阿片类药物的使用和(2)社区网络中的护理。具体来说，这项研究将提供 具有阿片类药物特征信息的退伍军人管理局运营管理员、医院管理人员和临床医生 从患者的角度停止治疗。这些观点可以为停产的最佳实践提供信息 阿片类药物治疗，当临床指征时，同时减轻 停药、参与并使患者能够通过循证的非 退伍军人事务部和社区内提供的阿片类药物治疗方式。

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.