Department of Medicine, University of Chicago, 5841 S. Maryland Ave., Rm. B200, MC 2007B, Chicago, IL, 60637, USA.
Access Community Health Network, Chicago, IL, USA.
Trials. 2022 Jul 27;23(1):602. doi: 10.1186/s13063-022-06537-w.
Older adults with chronic pain, opioid use, and opioid use disorder (OUD) present complex management decisions in primary care. Clinical tools are needed to improve care delivery. This study protocol describes the planned implementation and evaluation of I-COPE (Improving Chicago Older Adult Opioid and Pain Management through Patient-centered Clinical Decision Support and Project ECHO®) to improve care for this population.
This study uses a pragmatic, expanding cohort stepped-wedge design to assess the outcomes. The study will be implemented in 35 clinical sites across metropolitan Chicago for patients aged ≥ 65 with chronic pain, opioid use, or OUD who receive primary care at one of the clinics. I-COPE includes the integration of patient-reported data on symptoms and preferences, clinical decision support tools, and a shared decision-making tool into routine primary care for more effective management of chronic pain, opioid prescribing, and OUD in older adults. Primary care providers will be trained through web-based videos and an optional Project ECHO® course, entitled "Pain Management and OUD in Older Adults." The RE-AIM framework will be used to assess the I-COPE implementation. Effectiveness outcomes will include an increased variety of recommended pain treatments, decreased prescriptions of higher-risk pain treatments, and decreased patient pain scores. All outcomes will be evaluated 6 and 12 months after implementation. PCPs participating in Project ECHO® will be evaluated on changes in knowledge, attitudes, and self-efficacy using pre- and post-course surveys.
This study will provide evidence about the effectiveness of collecting patient-reported data on symptoms and treatment preferences and providing clinical decision support and shared decision-making tools to improve management for older adults with chronic pain, opioid use, and OUD.
ClinicalTrials.gov NCT04878562 .
患有慢性疼痛、阿片类药物使用和阿片类药物使用障碍（OUD）的老年患者在初级保健中提出了复杂的管理决策。需要临床工具来改善护理服务。本研究方案描述了通过以患者为中心的临床决策支持和 ECHO®项目（改善芝加哥老年阿片类药物和疼痛管理）来改善此类人群护理的 I-COPE（改善芝加哥老年阿片类药物和疼痛管理的计划实施和评估）的实施和评估。
本研究采用实用的、扩展队列的阶梯式设计来评估结果。该研究将在芝加哥大都市的 35 个临床站点进行，纳入的患者为≥65 岁，患有慢性疼痛、阿片类药物使用或 OUD，在其中一家诊所接受初级保健。I-COPE 包括将症状和偏好的患者报告数据、临床决策支持工具和共享决策工具整合到常规初级保健中，以更有效地管理老年慢性疼痛、阿片类药物处方和 OUD。初级保健提供者将通过网络视频和一个名为“老年疼痛管理和 OUD”的可选 ECHO®课程接受培训。将使用 RE-AIM 框架评估 I-COPE 的实施情况。有效性结果包括增加推荐的疼痛治疗方法的多样性、减少高风险疼痛治疗方法的处方数量以及减少患者疼痛评分。所有结果将在实施后 6 个月和 12 个月进行评估。参与 ECHO®项目的初级保健提供者将使用课程前后的调查评估知识、态度和自我效能的变化。
本研究将提供关于收集症状和治疗偏好的患者报告数据以及提供临床决策支持和共享决策工具以改善慢性疼痛、阿片类药物使用和 OUD 老年患者管理的有效性证据。
ClinicalTrials.gov NCT04878562。
