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

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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.