Racial Disparities in Lupus Clinical Trial Participation
By Saira Z. Sheikh, MD
Why was this study done? Lupus disproportionately affects Black and Latino populations, particularly women in childbearing years. Clinical trials of patients with lupus can advance the development of therapeutics and access to better treatments, as well as improve health outcomes for patients. However, a persistent disparity exists between racial and ethnic patient populations affected most by lupus and those represented in clinical trials. Numerous barriers to engaging patients and providers in clinical trials for lupus have been identified, including a lack of awareness, knowledge or understanding of available trials, trial protocols, eligibility criteria and referral processes.
What were the study methods? The ACR developed an online educational course for healthcare providers involved in the care of patients with lupus to increase knowledge, attitudes, self-efficacy and intentions to refer Black and Latino patients to clinical trials: the Materials to Increase Minority Involvement in Clinical Trials (MIMICT). We used a randomized, two-group, pretest/post-test design to assess the impact of the MIMICT educational intervention on cognitive outcomes theoretically related to behavior change.
What were the key findings? The intervention group had significantly higher post-test scores for knowledge, self-efficacy and intentions to refer Black and Latino patients to clinical trials than the control group. Intervention group participants reported favorable satisfaction with the MIMICT education course, which was strongly and positively correlated with intentions to refer diverse patients to clinical trials at post-test.
What were the main conclusions? The MIMICT education course is an effective resource in addressing provider-side barriers to clinical trial referrals by increasing knowledge about, self-efficacy toward, and intentions to refer Black and Latino patients to clinical trials.
What are the implications for patients? Clinical trials focused on lupus have not been adequately representative of diverse populations, particularly racial and ethnic minorities in the U.S. Black and Latino patients may have more access and opportunities to participate in clinical trials if healthcare providers are better equipped with the knowledge and tools to effectively engage patients in clinical trial discussions so patients can make informed decisions about participation in clinical trials.
What are the implications for clinicians? Healthcare providers act as a critical bridge to connect patients with clinical trial opportunities. Increasing knowledge and awareness about lupus and clinical trial disparities among rheumatologists, primary care providers and subspecialists providing care to patients with lupus, can potentially increase referrals and, ultimately, representation of Black and Latino patients in clinical trials.
The study: Wanty NI, Cooper DL, Simkus A, et al. A provider-based approach to address racial disparities in lupus clinical trial participation. Arthritis Care Res (Hoboken). 2022 Nov 7. doi: 10.1002/acr.25054. Epub ahead of print.
Post-Discharge Follow-Up in Lupus
By Maria Schletzbaum, PhD, & Christie Bartels, MD, MS
Why was this study done? Many patients with systemic lupus erythematosus are hospitalized—some frequently. In other chronic diseases, follow-up visits shortly after discharge reduce the risk of readmission within 30 days. We wanted to know how many patients with lupus had visits with their primary care provider or rheumatologist after leaving the hospital, and if such visits decreased the risk of a return to the hospital, to the emergency department (ED) or death.
What were the study methods? The study included 8,606 patients with lupus who were hospitalized and had Medicare coverage. We report how many patients completed a visit with a primary care provider or rheumatologist, and how many experienced a hospitalization, ED visit or death in the 30 days after discharge. We used multivariable logistic regression to evaluate which patients were less likely to have follow-up visits. Using Cox proportional hazards models with a time variable for follow-up, we conducted a survival analysis to assess whether follow-up visits affected the risk of readmission, ED visit or death.
What were the key findings? Over one-third of patients with lupus (35%) lacked follow-up within 30 days; 18% had their first follow-up visit with a rheumatologist. Lack of visits was more common in rural areas and highly socioeconomically disadvantaged neighborhoods. For patients aged 65 or older, follow-up was associated with 27% higher subsequent hospital or ED use, but 65% lower mortality. Visits with rheumatologists were not associated with acute care or mortality.
What are the main conclusions? Post-discharge follow-up visits are important and are likely underutilized in the care of patients with lupus. Greater rheumatologist involvement in post-discharge care and outreach to patients in rural and socioeconomically disadvantaged areas could be beneficial.
What are the implications for patients? It is important for patients with lupus to attend visits with their primary care provider or rheumatologist within 30 days of leaving the hospital.
What are the implications for clinicians? Post-hospital care of patients with lupus is important. Timely post-discharge visits aim to limit readmissions, ED visits and may significantly reduce mortality among older patients.
The study: Schletzbaum M, Sweet N, Astor B, et al. Associations of post-discharge follow-up with acute care and mortality in lupus: A Medicare cohort study. Arthritis Care Res. 2023 Feb 8. doi: 10.1002/acr.25097. Epub ahead of print.
