Long-Term Opioid Therapy: Screen to Evaluate and Treat (Opioid-SET)

背景：尽管大量VHA患者（> 30万）接受长期阿片类药物治疗（LTOT）， 其危害的证据越来越多（例如，疼痛控制不足、副作用、过量）。尽管VA/DoD 指南建议对LTOT患者进行频繁的多组分监测，监测未得到充分利用 因为它不符合初级保健的工作流程。此外，阿片类药物停药率正在增加， 即使中断通常是有害的（例如，更多地使用街头海洛因，精神健康恶化）。 此外，对于持续LTOT和逐渐减量以终止治疗的患者， 潜在的危害，临床实践指南（CPG）是不可用的，使他们“指南孤儿”。 意义：随着阿片类药物过量死亡和由于合并症导致的LTOT并发症的增加，政策 重点已经转移到减少阿片类药物处方，监测和停用LTOT中的阿片类药物 患者该项目将帮助提供者在应对政策变化的同时保持高质量的患者护理。它 解决了VHA和HSR&D的目标，即通过为提供者提供一个综合的 减少由于LTOT持续和中断造成的危害的工具，这些危害广泛而严重 在退伍军人中。创新：该项目有可能通过提供初级保健来改变LTOT实践 和其他供应商的新的，易于使用的筛选工具，这将有助于遵守建议的准则 监测LTOT患者，并在LTOT有害时停止LTOT。集成仪器可以 纳入CPRS，以促进其在VA医疗保健诊所的使用。该项目还将改变做法， 为不存在CPG的具有挑战性的LTOT患者组提供新的临时指南。 要完成的工作是对VHA计划的补充， 平衡疼痛管理和阿片类药物处方的实践，“S.T.O.P.P.A.I. N”，即，分级护理模式; 替代治疗;持续监测使用情况;以及实践指南。具体目标是发展一个 具有两个筛选工具的集成仪器，第一个指示LTOT是否有害继续（是或否; 目标1），第二个指示逐渐减少以停止阿片类药物是否对启动有害（是或否;目标2）。 积极的屏幕将表明，提供者应进行额外的，更全面的监测， 检查以确定继续LTOT或逐渐减少至停药的危害。目标3： 通过确定“指南孤儿”LTOT的初步治疗方法通知后续CPG 患者开发工具的方法将包括（1）全面的文献检索，以产生一个初始项目 每种筛查工具的数据库;（2）使用患者和提供者的焦点小组进行定性项目分析， 与患者的认知访谈，专家评审和项目修订，为每个项目产生小项目库 用于现场测试的筛选工具;以及（3）现场测试，以产生每个筛选工具的最终项目库， 将包括（a）将患者（每种工具n=500）的电话调查响应与其电子健康联系起来 记录来自公司数据仓库的数据，和（B）可靠性测试（n=30名患者）。工作方法 将遵循与制定VA/DoD CPG相同的方法， 物质使用障碍，包括（1）进行系统性审查，（2）从 （3）起草并提交关于“孤儿”管理的初步指南 LTOT患者与我们在该项目上的运营合作伙伴。下一步/实施： 研究计划将是一个多站点项目，以检查在何种程度上使用筛选工具， 由该提议的研究产生的潜在CPG与改善的患者结果相关（例如，少 过量），以及卫生保健系统的利用和成本（例如，急诊室就诊次数减少， 阿片类药物相关急性危象的住院治疗）。接下来的步骤还包括在质量改进方面建立伙伴关系 在VA初级保健和疼痛诊所实施筛查工具和CPG的项目。

Background: Despite high numbers of VHA patients (>300,000) receiving long-term opioid therapy (LTOT), evidence of its harms is growing (e.g., inadequate pain control, side effects, overdoses). Although VA/DoD Guidelines recommend frequent, multi-component monitoring of LTOT patients, monitoring is under-utilized because it does not fit with primary care’s workflow. In addition, rates of opioid discontinuation are increasing, even though discontinuation is often harmful (e.g., more use of street heroin, worsening mental health). Further, for patients for whom both continued LTOT and tapering for discontinuation are determined to be potentially harmful, a clinical practice guideline (CPG) is not available, leaving them “guideline-orphaned.” Significance: With increasing opioid overdose deaths and complications of LTOT due to comorbidities, policy emphases have shifted to reducing opioid prescribing, and monitoring and discontinuing opioids among LTOT patients. This project will help providers maintain high-quality patient care while responding to policy shifts. It addresses the VHA’s and HSR&D’s goal of offering patient-centered care by giving providers an integrated instrument to reduce harms due to LTOT continuation and discontinuation, which are widespread and severe among Veterans. Innovation: This project has the potential to change LTOT practices by giving primary care and other providers new, easy-to-use screening tools that will facilitate adherence to recommended guidelines on monitoring of LTOT patients, and discontinuation of LTOT when it is harmful. The integrated instrument may be incorporated into CPRS to facilitate its use in VA health care clinics. The project will also change practice by providing new, provisional guidelines for a challenging group of LTOT patients for whom CPGs do not exist. The work to be accomplished is complementary to VHA initiatives by contributing to components of best practices for balancing pain management and opioid prescribing, “S.T.O.P. P.A.I.N,” i.e., Stepped care model; Treatment alternatives; Ongoing monitoring of usage; and Practice guidelines. Specific Aims are to develop an integrated instrument with two screening tools, the first to indicate if LTOT is harmful to continue (yes or no; Aim 1), and the second to indicate if tapering to discontinue opioids is harmful to initiate (yes or no; Aim 2). Positive screens will indicate that providers should undertake additional, more comprehensive monitoring and examination to determine the harm of continued LTOT or tapering to discontinuation, respectively. Aim 3: Inform subsequent CPGs by determining preliminary treatment approaches for “guideline-orphaned” LTOT patients. Methods to develop the tools will involve (1) comprehensive literature searches to yield an initial item bank for each screening tool; (2) qualitative item analyses using focus groups with patients and providers, cognitive interviewing with patients, expert review, and item revision to yield small item banks for each screening tool for field testing; and (3) field testing to yield the final bank of items for each screening tool, which will include (a) linking patients’ (n=500 for each tool) telephone survey responses to their electronic health record data from the Corporate Data Warehouse, and (b) reliability testing (n=30 patients). Methods to work toward the CPG will follow the same methods used to develop the VA/DoD CPG for the Management of Substance Use Disorders, which consist of (1) conducting a systematic review, (2) obtaining input from the expert reviewers, and (3) drafting and submitting a preliminary guideline about the management of “orphaned” LTOT patients to our operations partners on this project. Next steps/Implementation: The next step in this research program will be a multi-site project to examine the extent to which use of the screening tools and potential CPG, resulting from this proposed study, is associated with improved patient outcomes (e.g., fewer overdoses), and health care system utilization and costs (e.g., fewer emergency department visits and hospitalizations for opioid-related acute crises). Next steps also include partnering on quality improvement projects to implement the screening tools and CPG in VA primary care and pain clinics.