Tuesday, September 30, 2025 9/30/2025

CO-LEADER: Intervention to Improve Patient-Provider Communication and Medication Adherence among Patients with Systemic Lupus Erythematosus

Award Number: R01MD018977
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/23/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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CO-LEADER: Intervention to Improve Patient-Provider Communication and Medication Adherence among Patients with Systemic Lupus Erythematosus - Systemic lupus erythematosus (SLE) is a multi-organ autoimmune disease that is 2-4x more common among Black 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 delivery and test the effect of CO-LEADER (COmmunication for Lupus Engagement 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 heterogeneous 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 communication-based SLE medication adherence intervention. The proposal is significant because successful completion of the award will provide robust data on an intervention that has high potential for implementation across many health systems to fill a critical gap in the care of patients with SLE.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $759,718 )
2025	2025	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	001	3	3/31/2025	NON-COMPETING CONTINUATION	$759,718
2025	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	000	2	3/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $759,718

Issue Date FY: 2024 ( Subtotal = $669,780 )
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	001	2	4/2/2024	NON-COMPETING CONTINUATION	$602,803
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	002	2	6/17/2024	NON-COMPETING CONTINUATION	$66,977
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	000	1	11/29/2023	NEW	$0
														Subtotal = $669,780

Issue Date FY: 2023 ( Subtotal = $664,056 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	001	1	9/24/2023	NEW	$0
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Minority Health and Health Disparities Research	000	1	9/23/2023	NEW	$664,056
														Subtotal = $664,056

Grand Total All Awards = $2,093,554

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CO-LEADER: Intervention to Improve Patient-Provider Communication and Medication Adherence among Patients with Systemic Lupus Erythematosus

Award Number: R01MD018977

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/23/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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