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

基本信息

批准号：
10539159
负责人：
Andrea Lynne Cheville
金额：
$ 82.47万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-06 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10539159
关键词：
Address Adoption Adult Advanced Malignant Neoplasm Affect Algorithms Cancer Pain Management Cancer Patient Cancer Survivor Caring Case Manager Cessation of life Characteristics Chronic Cancer Pain Clinical Clinical Trials Communication Communities Data Data Collection Detection Development Disease Effectiveness Elderly Electronic Health Record Elements Foundations Goals Guidelines Health Services Accessibility Health system Healthcare Systems Hispanic Hybrids Institutionalization Intervention Language Latinx Linguistics Link Liver Location Low income Machine Learning Malignant Neoplasms Mediating Mediator of activation protein Medical Modality Modeling Monitor Moods Outcome Outcome Measure Pain Pain management Patient Care Team Patient Outcomes Assessments Patient Recruitments Patients Pattern Persistent pain Persons Pharmaceutical Preparations Phase Physical Function Procedures Provider Quality of life Randomized Randomized Clinical Trials Rehabilitation therapy Reporting Research Resource-limited setting Resources Rural Services Sleep Specialist Survivors Symptoms System Testing Unemployment Vulnerable Populations Work arm base cancer care cancer health disparity cancer pain cancer therapy care coordination care delivery care outcomes care providers care seeking chronic pain clinical decision support collaborative approach collaborative care community organizations demographics design digital disability effectiveness clinical trial effectiveness evaluation ethnic minority evidence base exhaustion experience flexibility geographic barrier health care service utilization implementation evaluation implementation strategy improved improved functioning individualized medicine intense pain meetings multidisciplinary multilevel analysis multimodality novel opioid epidemic pain outcome pain reduction patient oriented patient population patient portal personalized care preference prescription opioid response role model rural Hispanic rural area rural dwellers rural residence social social culture social health determinants telecare treatment as usual treatment planning virtual

项目摘要

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.

抽象的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且独特的，因为他们削弱他们本已有限的获得、耐受和/或接受癌症治疗的能力。护理不善、不必要的持续剧烈疼痛，以及多模式阿片类药物处方过多和不足。疼痛护理 (MMPC) 是一种经过严格验证、更安全、更有效的替代单纯药物疗法的方法事实证明，广泛实施具有挑战性，并且在资源有限的环境中几乎不可能。 MMPC 的提供；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 选择协调差异使之成为改进的关键目标。协作护理模式 (CCM) 提供了良好的解决方案。建立并经过验证的框架，可以消除使差异长期存在的因素，指导 MMPC 交付并改进然而，根据目前的配置，CCM 的单一症状重点需要进行。我们的团队开发并测试了 CCM 迭代，以解决疼痛差异的多层次驱动因素。基于团队的护理 (TBC) 的重要组成部分，以改善 CCM 对社会文化需求的监测，并适应此外，我们还利用电子健康记录 (EHR) 来实现 MMPC 的多学科护理要求。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。 CCM-TBC 混合干预措施与以患者和护理团队为中心的 EHR 重新设计也得到了显着改善患者症状报告和 MMPC 部署这些努力虽然卓有成效，但也向我们展示了更广泛的成果。需要对 EHR 进行改造，以满足患者的广泛需求和现实临床工作的要求 - 这一经验表明，在 EHR 支持的支持下，灵活的模块化 CCM-TBC 混合系统可以降低流程的成本。肝脏高保真 MMPC 以改善护理并减少西班牙裔和西班牙裔之间多个层面的差异的方式我们计划在一项题为“实现公平”的临床试验中对这种方法的有效性进行农村评估。通过社会文化知情、数字化的癌症疼痛管理 (ASCENT)，我们将部分- 在最初的 1 年 R61 开发阶段与我们的社区利益相关者合作，完善文化信息我们的 CCM-TBC 混合版本，可满足西班牙裔和农村幸存者的语言、社会和 IT 需求（目标 1）。确认干预组件的功能后，我们计划过渡到 4 年 R33 执行阶段一项 2 臂、平行组随机临床试验（目标 2）将在 4 个半自主医疗保健系统中进行。项目，旨在评估我们的文化背景 CCM-TBC 混合干预是否可以改善疼痛结果相关 578 名幸存者接受常规护理，其中 60% 是农村人，60% 是西班牙裔，假设原发性疼痛和继发性疼痛有 30% 重叠。（情绪、睡眠、身体机能、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。除患者报告的结果测量外，将从 EHR 中提取主要效应以及探索性数据中介和机器学习分析；后者将识别与积极响应相关的特征。评估实施策略，以支持多利益相关方采用和使用干预措施。