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：我们将扩大现有的、以患者为中心的健康素养战略，以促进 在资源有限的农村卫生诊所通过以下方式长期坚持结直肠癌(CRC)筛查 结肠镜检查或年度粪便免疫化学检测(FIT)。在最近完成的试验的指导下，我们将利用 现在农村地区可用的消费技术，并实施多方面的方法- 专为资源有限的联邦合格医疗中心(FQHC)的规模而设计。在取得显著收益的同时， 虽然为改进儿童权利公约筛查作出了努力，但对这些准则的遵守情况并不理想，差距依然存在。 特别是，在资源有限的农村FQHC接受护理的成年人难以发起和 通过最常见的方法FIT保持每年一次的CRC筛查。在过去的十年里，我们的团队 研究了具体干预措施的有效性，以加强初次和重复的结直肠癌筛查完成 在收入较低、健康素养较低、种族/民族多样化的农村FQHC环境中。大多数人 的患者将完成初步测试(67%-69%)，但在第二年完成年度测试的患者较少(32%-40%) 3.这表明需要一种“分级护理”的方法来促进长期的结直肠癌筛查。我们的农村 到目前为止，由于州医疗补助计划的限制，健康素养干预措施仅限于适合性 农村初级卫生保健机构结肠镜检查服务的覆盖率和临床带宽。医疗补助计划的变化有 现在扩大了结肠镜检查的可用性。我们现在提出一种新的以证据为导向的干预方法 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信息，激励， 和Engage-CRC筛查(Prime-CRC)。在我们提出的双臂随机对照试验(N=1200)中，两者 Prime-CRC和增强的日常护理部门将获得我们的健康素养循证做法 提供结直肠癌患者信息和咨询，以帮助患者做出选择合适或 结肠镜检查和简化的测试说明。Prime-CRC将另外采用分步护理的方法 提醒患者为定期结肠镜检查或完成年度结肠镜检查做好正确的结直肠癌筛查准备 合身。Prime-CRC手臂中的患者将通过自动呼叫或 来自其医疗保健提供者的短信文本(根据患者偏好)(录音或个性化文本) 主要结果是在3年内完成结肠镜检查或每年检查一次。我们的具体目标 目的是：测试Prime-CRC干预措施的有效性，以提高#年CRC筛查完成率 与加强的日常护理相比，农村口蹄疫保健中心的情况有所改善。调查干预是否可以减少CRC 根据患者的健康素养、种族或性别来筛查差异。确定Prime-CRC的保真度或可靠性 组件，并探索患者、提供者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。这项研究延续了我们团队长期以来的 在健康普及、健康差距、农村健康和癌症筛查方面开展合作。