Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers

项目概要/摘要 结直肠癌（CRC）是美国癌症死亡的主要原因。国家指南建议 平均风险人群接受定期CRC筛查。社区卫生中心，如联邦资格 健康中心（CIMHC）为全国服务不足的人群提供高质量的负担得起的医疗保健。 在接受CRC治疗的患者中，只有44%的患者在推荐的范围内完成了CRC筛查。 时间帧（例如，每十年一次结肠镜检查）。已证明患者导航可有效改善CRC 筛查完成率和筛查质量。患者导航的效果在以下方面是稳健的： 社会经济地位和种族/族裔群体。此外，广泛的研究已经证明了其在慢性丙型肝炎中的疗效。 设置.虽然有效，但患者导航需要人员配备和经济资源，限制了其 广泛传播，特别是在资源匮乏的环境中，如难民署。这项研究旨在完善 并测试一种名为eNav Toolkit的数字健康解决方案，该解决方案旨在提高 患者在医院接受治疗。eNav工具包将是一个网络应用程序，将协助CRC筛选决策 制作、预约提醒、准备说明/提醒、教育、激励性面试 支持和后续护理的联系。为了最大限度地扩大覆盖面，电子导航工具包将在任何 智能手机、平板电脑或计算机设备。就目标1而言，电子导航工具包1.0将在10名参与者中进行实地测试。 受试者将是符合CRC筛查条件的CIMHC患者。现场测试结果可用于改进电子导航系统 内容和改善用户体验。干预的第二个迭代，eNav Toolkit 2.0，将是 在新的一组10名参与者上进行现场测试。第二次实地测试的结果将用于改进和 完成电子导航工具包。Aim 2将进行一项多中心随机临床试验，以评估 eNav工具包，用于改善在CIMCs治疗的患者中的CRC筛查吸收。患者（N=400）将 随机分配到两个条件之一：eNav Toolkit组（N=200）或常规护理组（N=200）。 电子导航工具包小组的参与者将参与电子导航工具包，以协助准备和完成 CRC筛查。常规护理组的受试者将接受常规护理。主要结局（CRC） 筛选完成）和次要结局（CRC筛选质量、随访依从性）进行评价 在研究入组后6个月。目标3将评估变革的理论机制（例如，感知 利益，感知的障碍，感知的易感性，自我效能），由健康信念模型指导。如果证明 有效的，eNav工具包将被集成到电子健康记录（EHR）中，并在全世界传播。 在全国范围内建立CRC中心，最终目标是减少在CRC中心接受治疗的患者的CRC负担。

PROJECT SUMMARY/ABSTRACT Colorectal cancer (CRC) is a leading cause of cancer death in the United States. National guidelines recommend that average risk people receive regular CRC screenings. Community health centers, such as federally qualified health centers (FQHCs), provide high quality affordable healthcare to underserved populations across the nation. Among patients treated at FQHCs, only 44% have completed a CRC screening within the recommended timeframe (e.g., one colonoscopy per ten years). Patient navigation has proven effective for improving CRC screening completion rates and screening quality. The effects of patient navigation are robust across socioeconomic status and racial/ethnic group. Furthermore, extensive research has proven its efficacy in FQHC settings. Although efficacious, patient navigation requires staffing and economic resources limiting its ability to be widely disseminated, particularly in low-resourced settings like FQHCs. The proposed study aims to refine and test a digital health solution, called the eNav Toolkit, designed to improve CRC screening uptake among patients treated at FQHCs. The eNav Toolkit will be a web app that will assist with CRC screening decision making, appointment reminders, preparation instructions/reminders, education, motivational interviewing support, and linkage to follow up care. In order to maximize reach, the eNav Toolkit will be accessible on any smartphone, tablet, or computer devise. For Aim 1, the eNav Toolkit 1.0 will be field tested on 10 participants. Participants will be FQHC patients eligible for CRC screening. The field test results be applied to refine the eNav content and improve the user-experience. The second iteration of the intervention, eNav Toolkit 2.0, will then be field tested on a new set of 10 participants. The results from the second field test will be applied to refine and finalize the eNav Toolkit. Aim 2 will conduct a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit for improving CRC screening uptake among patients treated at FQHCs. Patients (N=400) will be randomly assigned to one of two conditions: eNav Toolkit group (N=200) or usual care group (N=200). Participants in the eNav Toolkit group will engage with the eNav Toolkit to assist in preparing for and completing the CRC screening. Participants in the usual care group will receive usual care. Primary outcomes (CRC screening completion) and secondary outcomes (CRC screening quality, follow up adherence) will be evaluated at six months after study enrollment. Aim 3 will evaluate theoretical mechanisms of change (e.g., perceived benefits, perceived barriers, perceived susceptibility, self-efficacy), guided by the health belief model. If proven efficacious, the eNav Toolkit will be integrated in the electronic health record (EHR) and disseminated across FQHCs nationwide, with the ultimate goal of decreasing the burden of CRC among patients treated at FQHCs.