Tri-State Area Lupus Outreach and Clinical Trial Education Program - SLE is a chronic, disabling, potentially life-threatening autoimmune condition, characterized by heterogeneity and unpredictability. The approval of new lupus therapies has driven the increased interest in drug development in SLE and refocused attention on the need to include diverse populations in lupus clinical trials. Despite these new medications, there is still an urgent need for better SLE treatments, as only 10-20% of lupus patients that use advanced therapies achieve remission. Lupus is more common and severe in Black and Hispanic patients, and often has a more severe impact in patients with low education and low income, yet these patients are the least likely to participate in clinical trials. This project aims to increase participation of racial, and ethnic minority, socioeconomically disadvantaged, patients in clinical trials through an educational intervention developed during our current DHHS-OMH funded project. We developed educational audio-visual aids that can be used by the education team, peers, or as a stand-alone intervention within and outside clinic appointments. We propose to investigate how well the program performs when expanded from the academic sites where it was initially launched, to also include non-academic rheumatology centers in urban, suburban, and rural areas. GOALS: 1. Provide online/in person educational services, using our previously developed materials, to patients in the Tri-state (NY, NJ, CT) Area and Deep South (AL) to improve SLE clinical trial knowledge and increase clinical trial participation for SLE patients of Black/African American and Hispanic descent in urban, suburban, and rural areas, including community health setting with limited access to specialized lupus care. a. Personalize educational/informational sessions to patients' healthcare needs to include social determinants of health (SDOH) screenings and provide navigation resources by utilizing community health workers. b. Enhance the health education materials to incorporate lupus education and information on current therapeutic options in SLE. 2. Develop a lupus chatbot to expand the clinical trial education program and allow added time for questions, to further consider the issues, by including artificial intelligence to supplement the educational sessions in a subset of patients. OBJECTIVES: Through the proposed work, we will assess the implementation and impact of the clinical trial educational program to include lupus communities outside of the large academic lupus centers, with the following three short term objectives: 1. Implement the enhanced educational and engagement program that includes evaluation of SDOH in Tri-state area rheumatology and Alabama general medicine practices. a. Assess the feasibility of the program implementation in areas with large numbers of patients but limited resources for specialized lupus care. b. Assess the impact of educational sessions on knowledge, attitude, self-efficacy, and intention to participate in clinical trials by conducting a randomized wait-list control design study in lupus patients stratified by race and care setting - dedicated lupus center vs. rheumatology clinic vs. general medicine clinic. 2. Evaluate program satisfaction among providers and patients. 3. Develop a lupus chatbot. OUTCOMES: 1 a. Feasibility test the program implementation by monitoring the number of patients enrolled at each site. 1 b. Improve scores from pre- to post-test by using an established questionnaire that assesses knowledge, attitudes, self-efficacy, and intentions, for patients in the education intervention arm vs. waitlist controls. 2. Program satisfaction scores for providers and lupus patients. 3. Develop a lupus and clinical trial education chatbot using a collaborative, iterative process that includes providers and patients, and conduct usability testing (N= 15). Participation in a clinical trial 1-3 years after the program will be evaluated as an exploratory outcome.
