Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial.
Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial.
复制标题
提高阿片类药物治疗（ISOT）安全性整群随机试验的研究方法和基线结果。
DOI：
10.1016/j.cct.2020.105957
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发表时间：
2020
影响因子：
2.2
通讯作者：
Dobscha,StevenK
中科院分区：
文献类型：
--
作者：
Morasco,BenjaminJ;Adams,MelissaH;Maloy,PatriciaE;Hooker,ElizabethR;Iacocca,MeganO;Krebs,ErinE;Carr,ThomasP;Lovejoy,TravisI;Saha,Somnath;Dobscha,StevenK
慢性疼痛的长期阿片类药物治疗（LTOT）存在不良反应，临床医生很少遵守阿片类药物治疗指南的建议，以降低风险和减轻阿片类药物相关的危害。提高阿片类药物治疗安全性（ISOT）干预的主要目标是减少与处方阿片类药物相关的危害。次要目的侧重于加强临床医生-患者关系，并且不会对疼痛相关结局产生负面影响（通过非劣效性分析进行检查）。该研究是一项随机分组试验，44名参加的初级保健提供者（PCP）被随机分配接受（1）关于以患者为中心的阿片类药物治疗方法的两小时教育研讨会或（2）教育研讨会加上由护士护理经理（NCM）提供的协作护理干预。患者被分配到与其治疗PCP相同的条件。ISOT基于慢性病护理模式，包括患者和提供者的激活、结果监测以及12个月内向PCP的反馈。NCM对干预患者进行基线评估，跟踪阿片类药物相关行为和结局，并为阿片类药物处方临床医生提供阿片类药物安全性的决策支持。在2016年6月至2018年10月期间，293名因慢性疼痛接受LTOT治疗的退伍军人参加了研究，完成了基线评估，并被分配到治疗条件。参与者被招募了12个月。在基线、6个月和12个月时对参与者进行了掩蔽评估。本手稿描述了研究原理、研究方法和基线结果。
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.