New York City Lupus Outreach and Clinical Trial Education Program

Systemic Lupus Erythematosus (SLE or lupus) is a chronic, disabling, potentially life-threatening autoimmune condition, characterized by heterogeneity and unpredictability. Lupus is more common and severe in black and Hispanic patients. New therapies are needed to prevent organ damage, improve quality of life, and increase life expectancy for people with lupus. However, patients that most need these new therapies are the least likely to participate in clinical trials. This project aims to increase participation of racial and ethnic minority patients in clinical trials through the extension of the Patient Advocates for Lupus Studies (PALS) program, a peer training program launched by Lupus Therapeutics and the Lupus Research Alliance. The face of American medicine and education rapidly evolved since 2020 as the COVID-19 pandemic reached the US. As it became clear that face-to-face interactions could not continue, learning became almost entirely virtual. The PALS program, too, became fully virtual and had a hard time reaching those that needed intervention most – the poor, uneducated, and minority patients. The current application seeks to evaluate the role of remote and in-person learning in lupus education. We propose to investigate how well the program performs in a hybrid format that provides learning in ways that are easiest for patients: in person or online, in clinical settings or community centers. This application addresses the MP-CPI-21-005: improve clinical trials participation for people with lupus. HYPOTHESIS: The PALS educational modules will result in improved knowledge and attitudes towards clinical trials in SLE. GOALS: 1. Provide online/in person educational services based on the PALS program to patients in Washington Heights and the larger New York City area to improve lupus- and general health- literacy and increase clinical trial participation by patients of African American and Hispanic descent. 2. Learning retention and continued work to break down barriers to trial participation by minority patients. OBJECTIVES: 1. Refine and test the PALS educational sessions by adding patient-centered decision aids to influence behavior. 2: Create an equivalent control group design by providing general health literacy education for controls. 3: Add a cross-over design. We propose to refine and expand the PALS program. We will enroll at least 200 SLE patients with variable levels of disease activity (inactive to severe) from multiple sites to evaluate these educational sessions. Patients will be randomly assigned to participate in either PALS intervention or general health literacy modules, the latter to be developed by our educational team. OUTCOMES: Measurable Outcome for: Objective 1: Improved scores from pre- to post-test using the PALS questionnaire for patients in the intervention arm. Objective 2: Improved scores from pre- to post-test assessment using the Pfizer health literacy questionnaire for patients in the control arm. Objective 3: Improved scores from pre- to post-test for patients that participate in the cross-over design. Participation in a clinical trial 1-3 years after the program will be evaluated as an exploratory outcome. We will evaluate the association of disease severity, demographic, and socioeconomic variables (including race, ethnicity, sex, education, insurance, zip code) as well as patient-reported measures for pain, fatigue and mood and improvement in knowledge, attitude, self-efficacy and intention to participate in clinical trial. We anticipate that lower socioeconomic status, higher disease severity, and depression might associate with least improvement. This proposal addresses the challenges of insufficient participation of minority patients in lupus clinical trials. Based upon our findings, we hope to expand the program to larger cohorts of patients and improve participation in lupus clinical trials and bring better therapies to people with lupus of all races and ethnicities