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: 10825429
• 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/10825429
• 关键词: Accounting; Acute; Address; Administrator; Attention; Caring; Cessation of life; 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; Overdose; Pain; Pain Clinics; Pain intensity; Pain interference; Pain management; Patient Monitoring; Patient-Centered Care; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacy facility; Population; Primary Care; Process; Prospective, cohort study; Qualitative Methods; Quality of Life Assessment; Quality of life; Race; Random Allocation; Reporting; Resources; Safety; Sampling; Secondary pain; Severities; Structure; Suicide attempt; Surveys; Symptoms; Telephone; Testing; Veterans; Volition; chronic pain management; chronic pain patient; cohort; design; empowerment; ethnic minority; evidence base; experience; follow up assessment; health care service utilization; health disparity; improved; non-cancer chronic pain; non-opioid analgesic; operation; opioid epidemic; opioid therapy; pain outcome; pain patient; prescription opioid; racial minority; 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 年处方高峰期，向近 900,000 名退伍军人发放了阿片类药物，比例为 退伍军人管理局的阿片类药物处方量随后逐年下降，配发的退伍军人人数不足 700,000 名 2016 年阿片类药物的使用情况。随着更广泛的实施，这些下降趋势可能会继续下去 退伍军人管理局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 尽管阿片类药物的停药率稳定，但不鼓励长期使用阿片类药物治疗慢性非癌症疼痛。 在退伍军人事务部，人们对停用阿片类药物的积极和消极后果知之甚少。 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 资源来控制疼痛的方法，以及 检查以患者为中心的结果，例如生活质量、疼痛、药物使用和心理健康症状 这项前瞻性队列研究将随机招募 1,144 名 VA 患者。 从接受长期阿片类药物治疗的 VA 患者群体中选出的所有患者都将完成 5 次治疗。 在基线、6、12、18 和 24 个月的随访中进行邮寄或在线调查评估，以评估 生活、疼痛、物质使用和心理健康症状的额外临床和药学数据将被提取。 我们将监测队列中患者阿片类药物剂量的减少情况。 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治疗。 评估阿片类药物停用后急性患者结局的调查 40 名患者的子集。 停止阿片类药物治疗将立即通过电话参加半结构化访谈 停药后以及停药后 6 个月和 12 个月的访谈将确定患者的情况。 阿片类药物停药过程、内部和外部使用的疼痛治疗方法的经验 VA 和停药后的患者结局 本研究有三个具体目的：(1) 比较急性期。 （即时）、中期（6 个月）和长期（12 个月）生活质量和疼痛结果 停止使用阿片类药物的患者与继续使用长期阿片类药物治疗 (LTOT) 的患者，(2) 测试调节作用 性别和种族/民族对以下患者的生活质量和疼痛结果变化的影响 与继续使用 LTOT 的患者相比，停止使用 LTOT，并且 (3) 使用定性方法来增强定量方法 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，并描述停药对患者与临床医生关系的影响。 定量和定性数据分析的结果将描述患者的体验和结果 接下来，阿片类药物的停用这项研究既及时又与当前国家 VA 优先事项高度相关。 具体而言，本研究将提供 (1) 疼痛和阿片类药物的使用以及 (2) 社区网络护理的目标。 退伍军人管理局运营管理员、医院管理人员和上级提供阿片类药物特征信息 从患者的角度来看，这些观点可以为停药提供最佳实践。 当有临床指征时，阿片类药物治疗，同时减轻阿片类药物的负面后果 停止治疗并让患者参与并赋予患者权力，通过基于证据的非治疗方法来管理慢性疼痛 VA 和社区内提供阿片类药物治疗方式。