Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT” (ASCENT) Clinical Trial

摘要 癌症疼痛差异在西班牙裔/拉丁裔和农村居民幸存者中是深刻的和独特的有害的，因为他们 削弱他们本来就有限的获得、耐受和/或接受癌症治疗的能力。差距平分秋色 由于护理不善、不必要的持续性和剧烈疼痛，以及阿片类药物处方过多和过少。多式联运 疼痛护理(MMPC)是一种得到有力验证的、更安全、更有效的替代单纯以药物为基础的方法 事实证明，广泛实施具有挑战性，而且在资源有限的情况下几乎是不可能的。阻碍中国发展的因素 MMPC的交付；提供商偏见、患者不愿报告疼痛以及缺乏以患者为中心的MMPC选项 调解差距，使它们成为改善的关键目标。协作护理模式(CCM)提供了良好的- 建立了经过验证的框架，可以中和导致差异持续存在的因素，指导MMPC交付，并促进 证明疼痛检测和治疗。但是，按照目前的配置，CCM的单一症状重点需要 经过修改，以解决疼痛差异的多层次驱动因素。我们的团队已经开发并测试了CCM迭代， 以团队为基础的护理(TBC)的基本要素，以改善CCM对社会文化需求的监测，以及与 MMPC的多学科护理要求日期。此外，我们还利用电子健康记录(EHR)- 有能力的护理团队将有症状的癌症患者与MMPC提供者和资源联系起来。我们之前的研究部署了 CCM-TBC混合干预和以患者和护理团队为中心的EHR重组也得到了显著改善 患者症状报告和MMPC的部署。这些努力虽然卓有成效，但也向我们表明， 需要EHR改装，以满足患者的广泛需求和现实世界临床工作的要求- 流动。这一经验表明，在EHR支持下，灵活、模块化的CCM-TBC混合系统可以 肝脏高保真MMPC，改善护理并缓解西班牙裔和 农村癌症幸存者。我们计划在一项名为“实现公平”的临床试验中评估这种方法的有效性 通过社会文化信息、数字化的癌症疼痛管理(ASCENT)。更具体地说，我们会分开- 在为期一年的R61初始开发阶段与我们的社区利益相关者合作，以完善了解文化的 我们CCM-TBC混合体的版本，满足西班牙裔和农村幸存者的语言、社会和IT需求(目标1)。之后 确认干预组件的功能后，我们计划过渡到为期4年的R33执行阶段 双臂平行组随机临床试验。这项试验(目标2)将在4个半自主的医疗保健系统中进行- TEMS，旨在评估我们的文化知识CCM-TBC混合干预是否可以改善疼痛结局-- 在578名幸存者中，60%是农村人，60%是西班牙裔，假设30%是重叠的。原发(疼痛)和继发 (情绪、睡眠、身体功能、工作状态和医疗保健利用率)结果将在0、3和6个月进行评估。全 除患者报告的结果测量外，数据将从EHR中提取以用于主要效果以及解释 中介者和机器学习分析；后者用于确定与积极反应相关的特征。目标3将 评估实施战略，以支持多方利益攸关方采用和使用干预措施组成部分。

Abstract Cancer pain disparities are profound and uniquely harmful among Hispanic/Latinx and rural dwelling survivors as they undermine their already limited ability to access, tolerate, and/or receive treatment for their cancer. Disparities are tied to poor care, needlessly persistent and intense pain, as well as the over- and under-prescribing of opioids. Multi-modal pain care (MMPC), a robustly validated, safer, and more effective alternative to a solely medication-based approach has proven challenging to implement broadly, and virtually impossible in resource limited settings. The factors that impede delivery of MMPC; provider bias, patients’ reluctance to report pain, and lack of patient-centered MMPC options, also mediate disparities making them key targets for improvement. The Collaborative Care Model (CCM) provides a well-es- tablished and validated framework that can neutralize factors that perpetuate disparities, guide MMPC delivery, and im- prove pain detection and treatment. However, as currently configured the CCM’s single symptom emphasis needs to be modified to address the multi-level drivers of pain disparities. Our team has developed and tested CCM iterations that inte- grate elements of team-based care (TBC) to improve the CCM’s monitoring of sociocultural needs, as well as to accommo- date MMPC’s multi-disciplinary care requirements. In addition, we have leveraged electronic health records (EHRs) to en- able care teams to link symptomatic cancer patients with MMPC providers and resources. Our prior research deploying CCM-TBC hybrid interventions with patient-and-care team-centered EHR-reengineering has also significantly improved patient symptom reporting and deployment of MMPC. These efforts, while fruitful, have also shown us that a broader EHR retrofitting is required to address the breadth of patients’ needs and the requirements of real-world clinical work- flows. This experience suggests that a flexible, modular CCM-TBC hybrid system, supported by EHR enablement, can de- liver high fidelity MMPC in a manner that improves care and mitigates disparities at multiple levels among Hispanic and rural cancer survivors. We plan to evaluate the effectiveness of this approach in a clinical trial entitled “Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT (ASCENT ).” More specifically, we will part- ner with our community stakeholders during an initial, 1-year R61 development phase to refine a culturally informed version of our CCM-TBC hybrid that addresses Hispanic and rural survivors’ linguistic, social, and IT needs (Aim 1). After confirming the functionality of the intervention’s components, we plan to transition to a 4-year R33 execution phase with a 2-arm, parallel group randomized clinical trial. This trial (Aim 2) will be conducted in 4 semi-autonomous Health Care Sys- tems and is designed to assess whether our culturally informed CCM-TBC hybrid intervention improves pain outcomes rela- tive to usual care among 578 survivors, 60% rural and 60% Hispanic, assuming 30% overlap. Primary (pain) and secondary (mood, sleep, physical function, work status, and healthcare utilization) outcomes will be assessed at 0, 3, and 6 months. All data, excepting patient reported outcome measures, will be extracted from the EHR for main effects, as well as explora-tory mediator and machine learning analyses; the latter to identify characteristics associated with positive responses. Aim 3 will evaluate implementation strategies to support multistakeholder adoption and use of intervention components.