权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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.

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将评价实施战略，以支持多方利益攸关方采用和使用干预措施。