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

通过社会文化知情、数字化的癌症疼痛管理 NT™ (ASCENT) 临床试验实现公平

• 批准号: 10931166
• 负责人: Jessica Danielle Austin
• 金额: $ 159.43万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-06 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10931166
• 关键词: Achieving; Equity; through; SocioCulturally; informed

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.

摘要 癌症疼痛差异在西班牙裔/拉丁裔和农村居住幸存者中是深刻和独特的有害因素，因为他们 削弱了他们已经有限的获得、耐受和/或接受癌症治疗的能力。差距被捆绑 护理不善，不必要的持续和强烈的疼痛，以及阿片类药物的过量和不足。多模态 疼痛护理（MMPC）是一种经过充分验证的、更安全、更有效的替代单纯药物治疗的方法， 事实证明，广泛实施具有挑战性，在资源有限的情况下几乎不可能。阻碍的因素 提供MMPC;提供者偏见，患者不愿报告疼痛，以及缺乏以患者为中心的MMPC选择，也 调解差距，使其成为改善的关键目标。协作护理模式（CCM）提供了一个良好的服务， 建立和验证的框架，可以消除使差异永久化的因素，指导MMPC的交付， 证明疼痛检测和治疗。但是，根据当前配置，CCM的单一症状重点需要 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， 加强团队护理的要素，以改善CCM对社会文化需求的监测，并接纳 MMPC的多学科护理要求。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混合干预与以患者和护理团队为中心的EHR重新设计也有显着改善 患者症状报告和MMPC部署。这些努力虽然富有成效，但也向我们表明， EHR改造需要满足患者需求的广度和现实世界临床工作的要求- 流动。这一经验表明，一个灵活的、模块化的CCM-TBC混合系统，在EHR支持下，可以 肝脏高保真MMPC，以改善护理并减轻西班牙裔和 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 通过社会文化知情的数字化癌症疼痛管理（ASCENT）。更具体地说，我们将分开- 在最初的1年R61开发阶段，与我们的社区利益相关者合作， 我们的CCM-TBC混合版本，解决西班牙裔和农村幸存者的语言，社会和IT需求（目标1）。后 在确认干预措施组成部分的功能后，我们计划过渡到为期4年的R33执行阶段， 一项2组、平行组随机临床试验。本试验（目标2）将在4个半自主医疗保健系统中进行， 目的是评估我们的文化知情CCM-TBC混合干预是否改善了疼痛结果， 在578名幸存者中，60%是农村人，60%是西班牙人，假设有30%的重叠。原发性（疼痛）和继发性 (mood睡眠、身体功能、工作状态和医疗保健利用）结果将在0、3和6个月时进行评估。所有 除患者报告的结局指标外，将从EHR中提取主要效应和探索性数据 中介和机器学习分析;后者用于识别与积极响应相关的特征。目标3将 评估实施战略，以支持多利益相关者采用和使用干预组件。