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

项目概要/摘要 炎症性肠病（IBD），包括克罗恩病（CD）和溃疡性结肠炎（UC），是慢性的， 无法治愈的复发性和衰弱性疾病IBD影响了美国300多万人 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IBD过程中健康的社会决定因素的作用，并确定减轻健康的方法 差距。这项研究计划的总体目标是提高生活质量，减少健康 （1）通过严格的流行病学研究，评估社会风险因素对自然环境的影响， IBD的历史，2）测试创新IBD管理策略对改善健康公平性的有效性 和结果，以及3）开发和评估知情的患者和提供者教育， 意识方案。 该项目将包括一项为期52周、务实、多中心、开放标签、随机临床试验， 在试验中嵌入前瞻性队列研究。我们将纳入1200名儿童（13- 17岁）和成人（> 17岁） 在6个儿科和5个成人研究中心发现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组。目的是评估协会 在儿童和成人中IBD的社会风险和自然史以及结果之间， 目标2将涉及制定多利益相关者知情的、量身定制的数字健康干预措施， 改善IBD管理和患者激活，然后进行务实的试验，以比较 干预与常规护理。 目标3将通过提供者和患者教育解决健康差距，提高IBD意识， 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患者的相关非营利组织和基层患者倡导团体， 创建，执行和评估现场，面对面和数字教育和意识计划。

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.