Multifaceted Intervention To Improve Graft outcome disparities in African American Kidney Transplants: MITIGAAT Study Protocol (Preprint)

Abstract

Outcome disparities for African American (AA) kidney transplant recipients is a public health issue that has plagued the field of transplant since its inception. Based on national data, AA recipients have nearly twice the risk of graft loss at five years post-transplant, as compared to Caucasians. Evidence demonstrates that medication non-adherence and high tacrolimus variability substantially impact graft outcomes and racial disparities, most notably late (>2-years) after transplant. Non-adherence is a leading cause of graft loss. Prospective multicenter data demonstrates that one-third of all graft loss is directly attributed to non-adherence. We have spent ten years of focused research to develop a comprehensive model explaining the predominant risk factors leading to disparities in AA kidney recipients. However, there are still gaps in patient level data that hinder a deeper understanding of the disparities. Lack of data from the patient often leads to provider biases, which will be addressed with this intervention. Culturally competent pharmacist-led interventions in medication therapy management (MTM) will also address therapeutic inertia. Pharmacist interventions will mitigate medication access barriers as well (cost, insurance denials). Thus, this multidimensional intervention addresses patient, provider, and structural factors that drive racial disparities in AA kidney recipients.

The goal of this prospective, randomized study is to determine the impact of multimodal health services intervention on health outcomes disparities in African American kidney transplant recipients.

MITIGAAT is a 24-month, two arm, 1:1 randomized controlled clinical trial involving 190 participants (95 in each arm) measuring the impact on adherence and control of late clinical issues for racial disparities in kidney recipients, through a technology-enabled, telehealth-delivered four-level intervention.

The aims of this study are to improve adherence and control of late clinical issues, which are predominant factors for racial disparities in kidney recipients, through a technology-enabled, telehealth-delivered four-level intervention. The key clinical issues for this study include tacrolimus variability, blood pressure, and glucose control (in those with DM). We will also assess the impact of the intervention on healthcare utilization (hospitalizations and ED visits) and conduct a cost-benefit analysis. Finally, we will assess the impact of the intervention on acute rejection and graft survival rates as compared to a large contemporary national cohort.

With this report, we describe the study design, methods, aims, and outcome measures that will be utilized in the ongoing MITIGAAT clinical trial.

ClinicalTrials.gov NCT06023615: https://www.clinicaltrials.gov/study/NCT06023615