RFA-DP-23-002, Improving Outcomes and Reducing Disparities for Patients with Inflammatory Bowel Disease through Epidemiology, Enhanced Disease Management, Dissemination, and Education

项目摘要/摘要 炎症性肠病(IBD)，包括克罗恩病(CD)和溃疡性结肠炎(UC)，是一种慢性、 无法治愈的复发和衰弱的疾病。美国有300多万人感染IBD 国家，包括所有年龄、性别、种族和社会经济地位的人。迫切需要更好地 确定健康的社会决定因素在IBD病程中的作用，并找出减轻健康的方法 差距。这项研究计划的首要目标是提高生活质量和减少健康 差异通过：1)严格的流行病学研究，以评估社会风险因素对自然 IBD的历史，2)测试创新的IBD管理策略改善卫生公平的有效性 和结果，以及3)开发和评估利益相关者知情的患者和提供者教育以及 提高认识的项目。 该项目将包括一项为期52周的务实、多中心、开放标签、随机的临床试验， 纳入试验的前瞻性队列研究。我们将包括1200名儿童(13-17岁)和成人(17岁)。 6个儿科部位和5个成人部位有IBD。目标1是一项前瞻性队列研究(n=800)，将包括 参与者被分配到务实试验的常规护理部门。其目的是评估该协会 儿童和成人IBD的社会风险、自然病史和结局之间的关系， 目标2将涉及开发多个利益攸关方知情的、量身定做的数字健康干预措施，以 改善IBD管理和患者激活，随后进行务实试验，以比较 干预与常规护理相比。 目标3将解决健康差距，并通过提供者和患者教育和 向研究人员、临床医生和患者传播研究结果和其他循证实践。 这项工作将汇集专业组织、医学教育活动、疾病- 代表不同IBD患者的相关非营利性和草根患者倡导团体，他们是 创建、实施和评估现场、面对面和数字教育和认知计划。

PROJECT SUMMARY/ABSTRACT Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic, relapsing and debilitating disorders without a cure. IBD affects more than 3 million individuals in the United States, including people of all ages, sex, race and socioeconomic status. There is a critical need to better define the role of social determinants of health on the course of IBD and to identify ways to mitigate health disparities. The overarching goals of this research program are to improve quality of life and reduce health disparities through: 1) rigorous epidemiological research to evaluate impact of social risk factors on the natural history of IBD, 2) testing the effectiveness of innovative IBD management strategies to improve health equity and outcomes, and 3) developing and evaluating stakeholder-informed patient and provider education and awareness programs. The project will consist of a 52-week, pragmatic, multi-center, open-label, randomized clinical trial with a prospective cohort study embedded within the trial. We will include 1200 children (13-17y) and adults (>17y) with IBD at 6 pediatric and 5 adult sites. Aim 1 is a prospective cohort study (n=800) that will be comprised of participants assigned to the usual care arm of the pragmatic trial. The aim is to evaluate the association between social risk and natural history and outcomes of IBD in children and adults, Aim 2 will involve the development of a multi-stakeholder informed, tailored digital health intervention to improve IBD management and patient activation followed by a pragmatic trial to compare the effectiveness of the intervention versus usual care. Aim 3 will address health disparities and increase IBD awareness through provider and patient education and the dissemination of study findings and other evidence-based practices to researchers, clinicians, and patients. This work will bring together a coalition of professional organizations, medical education events, disease- associated non-profits and grassroot patient advocacy groups representing diverse patients with IBD who are to create, conduct and evaluate live, in-person and digital education and awareness programs.