Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.
Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America; Department of Pharmacy, University of Washington, Seattle, WA, United States of America; Department of Epidemiology, University of Washington, Seattle, WA, United States of America.
Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 2021 Jul 2.
High-dose, long-term opioid therapy (LtOT) is associated with risk for serious harms. Rapid opioid discontinuation may lead to increased pain, psychological distress, and illicit opioid use, but gradual, supported opioid taper may reduce these risks. We previously demonstrated that an opioid taper support and pain coping skills training intervention reduced opioid dose more than usual care (43% vs 19% dose reduction from baseline), with no increase in pain intensity and a significant reduction in activity interference. We aim to adapt and test this intervention in the Kaiser Permanente Washington healthcare system with STRategies to Improve Pain and Enjoy life (STRIPE, NCT03743402), a pragmatic, randomized trial. Our goal was to randomize 215 participants on moderate-high dose (≥40 morphine milligram equivalent/day) LtOT to either cognitive-behavioral therapy-based pain coping skills training involving 18 telephone sessions over 52 weeks with optional opioid taper support or usual care. Data are collected from electronic health records, claims, and self-report. The primary outcomes are mean daily opioid dose and the pain intensity, interference with enjoyment of life, and interference with general activity (PEG) score at 12 months (primary time point) and 6 months (secondary time point). Secondary outcomes include having ≥30% opioid dose reduction from baseline, and patient-reported problem opioid use, opioid-related difficulties, pain self-efficacy, opioid craving, global impression of change, and anxiety and depressive symptoms at 6 and 12 months. If effective, this treatment could reduce opioid exposure and associated risks to patients, families, and communities while offering patients an alternative for managing pain.
高剂量、长期阿片类药物治疗（LtOT）与严重危害风险相关。快速阿片类药物戒断可能导致疼痛加剧、心理困扰和非法阿片类药物使用，但逐渐、有支持的阿片类药物减量可能会降低这些风险。我们之前的研究表明，阿片类药物减量支持和疼痛应对技能培训干预措施比常规护理更能减少阿片类药物剂量（从基线减少 43%对 19%），同时不会增加疼痛强度，并显著减少活动干扰。我们旨在将这种干预措施在 Kaiser Permanente Washington 医疗保健系统中进行改编和测试，采用 STRategies to Improve Pain and Enjoy life（STRIPE，NCT03743402），这是一项实用、随机试验。我们的目标是将 215 名中等至高剂量（≥40 吗啡毫克当量/天） LtOT 患者随机分配到认知行为治疗为基础的疼痛应对技能培训组，该组涉及 18 次电话会议，持续 52 周，并可选择接受阿片类药物减量支持或常规护理。数据来自电子健康记录、索赔和自我报告。主要结局指标是 12 个月（主要时间点）和 6 个月（次要时间点）时的平均每日阿片类药物剂量，以及疼痛强度、对生活享受的干扰、对一般活动的干扰（PEG）评分。次要结局指标包括与基线相比，阿片类药物剂量减少≥30%，以及患者报告的问题阿片类药物使用、阿片类药物相关困难、疼痛自我效能、阿片类药物渴求、总体变化印象、焦虑和抑郁症状在 6 个月和 12 个月时的情况。如果有效，这种治疗方法可以减少患者、家庭和社区的阿片类药物暴露和相关风险，同时为患者提供管理疼痛的替代方案。
