Morasco Benjamin J, Adams Melissa H, Maloy Patricia E, Hooker Elizabeth R, Iacocca Megan O, Krebs Erin E, Carr Thomas P, Lovejoy Travis I, Saha Somnath, Dobscha Steven K
Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America; Department of Psychiatry, Oregon Health & Science University, United States of America.
Center to Improve Veteran Involvement in Care, VA Portland Health Care System, United States of America.
Contemp Clin Trials. 2020 Mar;90:105957. doi: 10.1016/j.cct.2020.105957. Epub 2020 Feb 13.
There are adverse effects associated with long-term opioid therapy (LTOT) for chronic pain and clinicians infrequently adhere to opioid treatment guideline recommendations for reducing risk and mitigating opioid-related harms. The primary goal of the Improving the Safety of Opioid Therapy (ISOT) intervention is to reduce harms related to prescription opioids. Secondary aims focus on enhancing the clinician-patient relationship and not having a negative impact on pain-related outcomes (to be examined through a non-inferiority analysis). The study is a cluster-randomized trial and the 44 primary care providers (PCPs) who enrolled were randomized to receive either (1) a two-hour educational workshop about a patient-centered approach to opioid therapy or (2) the educational workshop plus a collaborative care intervention delivered by a nurse care manager (NCM). Patients were assigned to the same condition as their treating PCP. ISOT was based on the chronic care model and includes patient and provider activation, outcomes monitoring, and feedback to the PCP over 12 months. The NCM conducted a baseline assessment with intervention patients, tracked opioid-related behaviors and outcomes, and provided decision support to the opioid-prescribing clinician about opioid safety. Between June 2016 and October 2018, 293 veterans who were prescribed LTOT for chronic pain were enrolled, completed a baseline assessment, and assigned to a treatment condition. Participants were enrolled for 12 months. Masked assessments were conducted with participants at baseline, 6-months, and 12-months. This manuscript describes study rationale, research methods, and baseline findings.
长期阿片类药物治疗（LTOT）用于慢性疼痛存在不良反应，且临床医生很少遵循阿片类药物治疗指南中关于降低风险和减轻阿片类药物相关危害的建议。改善阿片类药物治疗安全性（ISOT）干预措施的主要目标是减少与处方阿片类药物相关的危害。次要目标侧重于加强医患关系，且不对疼痛相关结局产生负面影响（将通过非劣效性分析进行检验）。该研究为整群随机试验，44名参与的初级保健提供者（PCP）被随机分为两组，分别接受：（1）一场为期两小时的关于以患者为中心的阿片类药物治疗方法的教育研讨会；或（2）该教育研讨会加上由护士护理经理（NCM）提供的协作护理干预。患者被分配到与他们的主治PCP相同的治疗组。ISOT基于慢性病护理模式，包括患者和提供者激活、结局监测以及在12个月内对PCP的反馈。NCM对干预患者进行基线评估，跟踪与阿片类药物相关的行为和结局，并就阿片类药物安全性向开具阿片类药物的临床医生提供决策支持。在2016年6月至2018年10月期间，293名因慢性疼痛接受LTOT治疗的退伍军人被纳入研究，完成基线评估并被分配到治疗组。参与者参与研究12个月。在基线、6个月和12个月时对参与者进行盲法评估。本手稿描述了研究原理、研究方法和基线研究结果。
