ABSTRACT
Systemic lupus erythematosus (SLE) is a multi-organ autoimmune disease that is 2-4x more common among
Black that White persons. Black patients with SLE are 6-7x more likely to suffer from kidney failure and die 13
years younger. Exacerbating these disparities, Black patients with SLE also have worse medication
adherence, which is partially explained by mistrust about medicines and the medical system. Trust can be built
through effective patient-clinician communication, but unfortunately, effective adherence communication occurs
sporadically, and Black patients experience poorer communication quality with clinicians and participate less in
decision making in clinic visits. Adherence interventions in SLE to date have only had limited success with
patient reminders and education and have not attended to the quality of patient-clinician communication nor
focused on ameliorating racial disparities in SLE medication adherence. The long-term goal is to reduce racial
disparities and improve health outcomes among patients with SLE. The overall objective of this proposal is to
optimize the culturally appropriate delivery and test the effect of CO-LEADER (COmmunication for Lupus
Equity in Adherence with DOSE-Nonadherence-SLE and Refill data), a simple and flexible intervention that
combines clinician training in communication skills centered around the needs of Black patients to effectively
utilized pharmacy refill data with patient-reported adherence barriers. Pilot data for CO-LEADER suggest that
1) it is feasible, 2) it can be performed with high fidelity, 3) it enables consistent adherence discussions with
excellent patient-clinician communication, and 4) it improves medication adherence while reducing racial
disparities. A Hybrid Type I design will be used to conduct a cluster randomized trial of CO-LEADER at 2
racially diverse rheumatology clinics. Informed by the Ecological Model of Patient-Centered Communication,
the central hypothesis is that CO-LEADER enables clinicians to consistently discover and collaboratively
address patients’ adherence barriers. More effective adherence discussions will then enhance shared
understanding, therapeutic alliance, and trust, thereby improving medication adherence, particularly for Black
patients. The aims of the study will compare important outcomes between clinicians randomized to CO-
LEADER and usual care to test the effect of the intervention on 1) patient-clinician communication via clinic
visit audio recordings and patient surveys, and 2) SLE medication adherence via pharmacy refill data. The
study will also simultaneously evaluate relevant implementation outcomes to identify areas for improvement in
the intervention’s delivery. This innovative proposal is the first to test a SLE adherence intervention with an eye
for equity in patient-clinician communication and medication adherence. The proposal is significant because
successful completion of the award will provide robust data on a culturally tailored intervention that has high
potential for implementation across many health systems to fill a critical gap in the care of patients with SLE.
