Unintended Prolonged Opioid Use

项目摘要 滥用处方阿片类药物仍然是一个公共卫生危机。适当短期使用这些药物 在阿片类药物初治患者中，适用于选定的卫生保健环境，但有意的短期使用正在出现， 这是一种以前未被认识到的非预期长期阿片类药物使用（UPOU）的后果。临床策略旨在 在卫生保健环境中缺乏预防UPOU的措施，部分原因是缺乏关于如何预防UPOU的信息。 临床现象的发展。 马约诊所的研究人员最近组织了一个思想领袖小组， 来解释UPOU这样一个框架对于指导对这一问题的研究和查明潜在的 减少UPOU的干预目标。该框架由三个领域组成，包括（1）患者 特征;（2）实践环境特征;（3）阿片类药物处方者特征， 要么促进要么阻碍UPOU。在每个领域内，从相关文献中得出的潜在因素， 缓和或调解每个域的影响。然而，评估这一点所需的大部分信息 框架目前还不存在。电子健康记录（EHR）的广泛采用提供了 转化研究的独特潜在机会，包括确定符合研究条件的受试者 参与并作为回顾性或前瞻性研究的数据来源。然而，互操作性 电子健康档案之间的差异对利用这些机会构成了相当大的挑战。 耶鲁大学医学院的研究人员最近推出了Hugo，一个安全的移动的个人健康 移动健康（mHealth）平台，使患者能够从多个EHR和其他医疗保健系统访问其信息 信息来源，包括商业药房记录。Hugo平台具有巨大的潜力， 促进临床研究，特别是跨多个中心进行的研究-作为来自不同领域的信息 每个机构的源系统可以很容易地集成到一个共同的数据集。 在本申请中，四个CTSA中心（马约诊所、明尼苏达大学、密歇根大学和耶鲁大学）将 探索Hugo平台促进临床研究的潜力，以UPOU研究为用例。我们将 使用Hugo平台识别UPOU事件病例，并前瞻性招募患者和阿片类药物 评估的处方，以及使用结构评估拟议的概念框架 方程模型在这项研究的结论，我们将成功地部署了一个高度创新的mHealth 跨多个中心的平台，该平台将立即用于广泛传播 在整个CTSA联盟和其他临床研究中心。获得的关于UPOU的信息将 显著地推进了关于这种知之甚少临床现象的核心知识。此新购入 信息将用于设计，测试和部署旨在减轻UPOU风险的预防策略。

PROJECT SUMMARY Misuse of prescription opioids remains a public health crisis. Appropriate short-term use of these medications in opioid-naïve patients is indicated in select health care settings, but intentional short-term use is emerging as a previously under-recognized segue to unintended prolonged opioid use (UPOU). Clinical strategies aimed at preventing UPOU in health care settings are lacking due, in part, to absence of information about how this poorly-understood clinical phenomenon develops. Investigators at Mayo Clinic recently organized a group of thought leaders to develop a conceptual framework to explain UPOU. Such a framework is essential both to guide the study of this problem and to identify potential targets for interventions to reduce UPOU. The framework is comprised of three domains, including (1) patient characteristics; (2) practice environment characteristics; and (3) opioid prescriber characteristics that interact to either facilitate or impede UPOU. Within each domain, potential factors, drawn from the relevant literature, moderate or mediate the influence of each domain. However, much of the information needed to evaluate this framework does not currently exist. The widespread adoption of electronic health records (EHR) provides unique potential opportunities for translational research, including identifying subjects eligible for study participation and serving as a data sources for retrospective or prospective studies. However, interoperability between EHRs poses a considerable challenge to taking advantage of these opportunities. Researchers at the Yale School of Medicine recently launched Hugo, a secure mobile personal health (mHealth) platform that enables patients to access their information from multiple EHRs and other healthcare information sources, including commercial pharmacy records. The Hugo platform has tremendous potential to facilitate clinical research, especially research conducted across multiple centers – as information from diverse source systems at each institution can be easily integrated into a common dataset. In this application, four CTSA hubs (Mayo Clinic, University of Minnesota, University of Michigan, and Yale) will explore the Hugo platform's potential to facilitate clinical research, with the UPOU study as a use case. We will use the Hugo platform to identify incident cases of UPOU and prospectively recruit patients and opioid prescribers for assessments, as well as to evaluate the proposed conceptual framework using structural equation models. At this study's conclusion, we will have successfully deployed a highly innovative mHealth platform across multiple centers and this platform will be immediately available for widespread dissemination across the entire CTSA consortium and other clinical research sites. The information gained about UPOU will significantly advance core knowledge about this poorly understood clinical phenomenon. This newly acquired information will be used design, test, and deploy prevention strategies aimed at mitigating the risks of UPOU.