Diagnosing and Treating Veterans with Chronic Pain and Opioid Misuse

背景：在开长期阿片类药物治疗(LTOT)的约1000万美国人中，多达30%是 估计是滥用阿片类药物。接受LTOT与阿片类药物相关的伤害有关，滥用会导致 消耗的剂量增加和其他危险行为，进一步恶化结果。然而，有一个差距 在如何识别和治疗这些患者群体方面的知识，特别是当他们不符合诊断标准时 阿片类药物使用障碍(OUD)药物治疗标准。近年来，来自世界银行的指导方针 疾病控制中心和退伍军人健康管理局(VHA)已经实施了广泛的缩减 以减少误用。丁丙诺啡是一种同时用于止痛和止痛的药物，它也可能有效地减少 阿片类药物在控制滥用LTOT患者疼痛时的相关伤害；然而，丁丙诺啡尚未奏效 在这些患者群体中进行严格的测试。因此，需要进行研究来确定接受LTOT治疗的患者是否患有 并比较不同治疗方法对患者预后的影响。 意义：慢性疼痛、用于疼痛的LTOT和阿片类药物滥用在退伍军人中很常见，并导致 多种与健康相关的危害。VHA已将改善疼痛护理和减少阿片类药物的危害作为一项主要任务 临床倡议的优先事项，这项建议回应了卫生服务研究和开发 (HSR&D)资金公告#HX-21-024，以解决与阿片类药物相关的优先事项。通过填写一个关键的 证据差距，这项提议将显著影响我们治疗疼痛的方式，并将对退伍军人的伤害降至最低 阿片类药物滥用。 创新和影响：这项建议在许多方面都是创新和有影响力的。首先，这个项目将利用 VHA的企业数据仓库(CDW)的独特功能，可以开发一种新的算法来识别 误用LTOT的患者。如果成功，这一自动识别过程有可能成为 扩展到全国各地的VHA地点。第二，不同治疗方法的比较效果将是 由模拟试验确定，创新和高效的研究设计可以带来更大的 普适性高于标准试验，标准试验在这一领域严重受到选择偏见的影响。治疗方法 在模拟试验中接受评估的人很容易获得，所以如果发现特定的治疗方法可以改善患者 症状并减少不良后果，有阿片类药物滥用的退伍军人将可以获得这些 全国范围内的治疗。最后，我们将收集供应商和退伍军人的反馈，以了解最好的 战略和干预措施，以扩大识别过程，并更好地向退伍军人和提供者提供 循证治疗方案。 具体目标：该项目旨在1)对长期服用阿片类药物滥用但没有滥用的患者进行分类 通过a)建立在先前开发的增强图表审查方法的基础上，以及b)应用 算法到结构化数据；2)进行模拟试验以比较药物的有效性 以患者为中心的治疗方案和患者安全结果；以及3)了解当前的做法和 如何通过对提供者和退伍军人的半结构化访谈，将我们的发现转化为改善护理。 方法：研究人群是2014年至今接受LTOT治疗并滥用阿片类药物的VHA患者。这项建议 使用混合的定量和定性方法，包括增强的结构化图表审查、大型数据集 使用顺序弹性网络回归、模拟试验和定性访谈进行分类。 下一步/实施：我们希望研究结果对VHA领导人、临床医生处方和 患有慢性疼痛的患者。如果成功，AIM 1的自动识别过程可以扩展到 VHA部位，如果目标2中评估的治疗在改善症状和减少不良反应方面有效 在取得成果的同时，这些措施也可以得到广泛实施。在目标3中，我们将收集经验丰富的意见，如何最好地 在各种环境下将目标1和目标2中的结果应用于临床实践。

Background: As many as 30% of the ~10 million Americans prescribed long-term opioid therapy (LTOT) are estimated to misuse opioids. Receiving LTOT is associated with opioid-related harms, and misuse leads to an increase in the dose consumed and other risky behavior, further worsening outcomes. However, there is a gap in knowledge on how to identify and treat this patient population particularly when they do not meet diagnostic criteria to be treated by medications for Opioid Use Disorder (OUD). In recent years, guidelines from the Centers for Disease Control and the Veterans Health Administration (VHA) have effected widespread tapering to reduce misuse. Buprenorphine, a medication used for both pain and OUD, may also be effective in reducing opioid-related harms while controlling pain for patients on LTOT with misuse; however, buprenorphine is yet to be tested rigorously in this patient population. Therefore, studies are needed to identify patients on LTOT with misuse and to compare the efficacy of different treatments on patient outcomes. Significance: Chronic pain, LTOT for pain, and opioid misuse are common among Veterans and lead to multiple health-related harms. The VHA has made improving pain care and reducing opioid harms a major priority of clinical initiatives, and this proposal responds to the Health Services Research and Development (HSR&D) Funding Announcement #HX-21-024 to address those opioid-related priorities. By filling a crucial evidence gap, this proposal will significantly impact the way we treat pain and minimize harm for Veterans with opioid misuse. Innovation and Impact: This proposal is innovative and impactful in many ways. First, this project will utilize the unique capabilities of the VHA’s Corporate Data Warehouse (CDW) to develop a novel algorithm to identify patients on LTOT with misuse. If successful, this automated identification process has the potential to be scaled to VHA sites across the country. Second, the comparative effectiveness of different treatments will be determined by an emulated trial, an innovative and efficient study design that can lead to greater generalizability than standard trials, which suffer significantly from selection bias in this area. The treatments being evaluated in the emulated trial are readily available, so if specific treatments are found to improve patient symptoms and reduce adverse outcomes, it will be feasible for Veterans with opioid misuse to access these treatments nationwide. Finally, we will gather feedback from providers and Veterans to understand the best strategies and interventions to scale the identification process and better inform Veterans and providers of evidence-based treatment options. Specific Aims: This project aims to 1) Classify a cohort of patients on LTOT with opioid misuse but without OUD by a) building on a previously developed augmented chart review methodology and b) applying an algorithm to structured data; 2) Conduct an emulated trial to compare the effectiveness of pharmacologic treatment options on patient-centered and patient safety outcomes; and 3) Understand current practices and how to translate our findings into improved care via semi-structured interviews with providers and Veterans. Methodology: The study population is VHA patients on LTOT with opioid misuse 2014-present. The proposal uses mixed quantitative and qualitative methods including augmented structured chart review, large dataset classification using ordinal elastic net regression, emulated trials, and qualitative interviews. Next Steps/Implementation: We expect findings to be of use to VHA leaders, prescribing clinicians, and patients with chronic pain. If successful, the automated identification process from Aim 1 could be scaled to VHA sites, and if treatments evaluated in Aim 2 are effective in improving symptoms and reducing adverse outcomes, these could also be implemented widely. In Aim 3, we will gather Veteran input on how to best implement findings from Aims 1 and Aim 2 into clinical practice in a variety of settings.