Patient-Centered Reminders to Inform, Motivate, and Engage Colorectal Cancer Screening Adherence in Rural Communities: The PRIME-CRC Trial

以患者为中心的提醒，以告知、激励和参与农村社区结直肠癌筛查的依从性：PRIME-CRC 试验

• 批准号: 10674940
• 负责人: Connie L. Arnold
• 金额: $ 39.45万
• 依托单位: LOUISIANA STATE UNIV HSC SHREVEPORT
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10674940
• 关键词: 2 arm randomized control trial; Address; Adherence; Adult; American Cancer Society; Cancer Intervention; Caring; Clinical; Collaborations; Colonoscopy; Colorectal Cancer; Cost Analysis; Counseling; Coupled; Data; Decision Making; Detection; Disparity; Education; Ethnic Origin; Ethnic Population; Evidence based practice; Federally Qualified Health Center; Funding; Guidelines; Health; Health Care Research; Health Personnel; Health Sciences; Healthcare Systems; Instruction; Intervention; Knowledge; Learning; Literature; Louisiana; Low Income Population; Low income; Medicaid; Methods; Minority Groups; Motivation; National Cancer Institute; Patient Preferences; Patients; Preparation; Printing; Provider; Race; Research; Resources; Rural; Rural Community; Rural Health; Rural Health Centers; Rural Population; Schedule; Screening for cancer; Services; Site; Socioeconomic Status; Standardization; Technology; Telephone; Testing; Text; Text Messaging; Universities; adenoma; arm; colon cancer patients; colorectal cancer screening; design; effectiveness study; effectiveness testing; ethnic diversity; evidence base; follow-up; gender disparity; health disparity; health inequalities; health literacy; implementation barriers; improved; literacy; literate; novel; outreach; patient oriented; patient population; personalized approach; point of care; primary care patient; primary care provider; primary outcome; racial disparity; racial diversity; racial minority; rural area; rural dwellers; rural health clinic; rural patients; screening; screening disparities; screening guidelines; sex; shared decision making; treatment as usual; usual care arm

Project Summary/Abstract: We will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). Guided by recently completed trials, we will leverage consumer technologies that are now available in rural areas and implement a multifaceted approach - designed for scale in resource-limited federally qualified health centers (FQHCs). While significant gains have been made to improve CRC screening, compliance with those guidelines is sub-optimal and disparities remain. In particular, adults who receive care at rural FQHCs that have limited resources struggle to initiate and maintain annual CRC screening via the most common method, FIT. Over the past decade, our team has studied the effectiveness of specific interventions to enhance initial and repeat CRC screening completion among lower income, lower health literate, racial/ethnically diverse adults in rural FQHC settings. The majority of patients will complete the initial test (67% - 69%), yet fewer (32% - 40%) complete an annual test in years 2 and 3. This indicates a ‘stepped care’ approach is needed to promote long-term CRC screening. Our rural health literacy interventions have until now been limited to the FIT due to restrictions of state Medicaid coverage and clinical bandwidth of colonoscopy services available to rural FQHCs. Changes to Medicaid have now expanded the availability of colonoscopy. We now propose a novel intervention guided by evidence learned from our previous studies and recent literature - the Patient-centered Reminders to Inform, Motivate, and Engage-CRC Screening (PRIME-CRC).In our proposed 2-arm, randomized control trial (N=1200), both PRIME-CRC and enhanced usual care arms will receive our health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy and simplified test instructions. PRIME-CRC will additionally have a stepped care’ approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will have frequent follow-up with tailored contact via automated call or SMS text (based on patient preference) from their healthcare provider (audio recorded or personalized text) .The primary outcome will be completion of either colonoscopy or annual FIT over 3 years. Our specific aims are to: Test the effectiveness of the PRIME-CRC intervention to improve CRC screening completion rates in rural FQHCs compared to enhanced usual care. Investigate whether the intervention can reduce CRC screening disparities by patient health literacy, race or sex. Determine the fidelity, or reliability of PRIME-CRC components, and explore patient, provider, and healthcare system barriers to implementation. Evaluate the cost associated with the intervention from a FQHC perspective. This study extends our team’s longstanding collaboration on health literacy, health disparities, rural health and cancer screening.

项目摘要/摘要：我们将扩展现有的，以患者为中心的健康素养策略来促进 长期遵守结直肠癌（CRC）在资源有限的农村健康诊所中筛查 结肠镜检查或年度粪便免疫化学测试（FIT）。在最近完成的试验的指导下，我们将利用 现在可以在粗糙区域中使用并实施多方面方法的消费者技术 - 专为资源有限的联邦合格卫生中心（FQHC）而设计。虽然有重大收益 我们是为了改善CRC筛查，遵守这些准则是次优的，并且仍然存在差异。 特别是，在资源有限的艰苦努力启动和 通过最常见的方法维护年度CRC筛查。在过去的十年中，我们的团队有 研究了特定干预措施以增强初始和重复CRC筛选完成的有效性 在较低的收入中，在粗糙的FQHC环境中，较低的健康素养，种族/种族多样化的成年人。多数 大量患者将完成初始测试（67％-69％），但在2年内完成年度测试（32％-40％） 3。这表明需要采用“阶梯护理”方法来促进长期CRC筛查。我们的乡村 由于国家医疗补助的限制 结肠镜检查的覆盖范围和临床带宽可用于粗糙的FQHC。医疗补助的变化有 现在扩大了结肠镜检查的可用性。我们现在提出了一种以证据为指导的新颖干预措施 从我们以前的研究和最近的文献中学到的 - 以患者为中心的提醒，以激励，激励， 和参与者筛选（Prime-CRC）。在我们提出的2臂随机对照试验（n = 1200）中 Prime-CRC和增强的常规护理臂将获得我们的健康识字循证实践 提供CRC患者信息和咨询，以帮助患者决策选择适合或 结肠镜检查和简化的测试说明。 Prime-CRC还将采用阶梯护理的方法 提醒患者进行适当的CRC筛查准备准备，以进行预定结肠镜检查或完成年度 合身。 Prime-CRC ARM中的患者将经常通过自动通话或通过自动电话进行量身定制的联系 SMS文本（基于患者偏好）的医疗保健提供者（记录或个性化文本） 主要结果将在3年内结肠镜检查或年度拟合度完成。我们的具体目标 是：测试Prime-CRC干预的有效性以提高CRC筛选完成率 与增强的平时护理相比，农村FQHC。调查干预措施是否可以减少CRC 筛查患者健康素养，种族或性别的差异。确定Prime-CRC的保真度或可靠性 组件，并探索患者，提供商和医疗保健系统实施的障碍。评估 从FQHC的角度来看，与干预相关的成本。这项研究扩展了我们团队的长期历史 健康素养，健康差异，粗糙的健康和癌症筛查的合作。