Thursday, May 16, 2024
5/16/2024
DESCRIPTION (provided by applicant): The best treatment for severe chronic kidney disease (CKD) is usually a live donor kidney transplant (LDKT), but large racial disparities persist in receipt of LDKTs. In 2009, Blacks, who comprised 36.9% of the dialysis population, received 32.4% of deceased donor kidney transplants (DDKTs) but just 13.7% of LDKTs. A multi- component intervention that addresses the many barriers that impede LDKT (e.g. transplant candidates' lack of knowledge about LDKT; fears regarding donor's future health; guilt; and discomfort with discussing LDKT) could plausibly increase LDKT among Blacks. Our main objective is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among newly-listed transplant candidates who are Black. We hypothesize that a multi-component intervention will increase both readiness to pursue LDKT and actual receipt of LDKTs among Blacks. We propose a parallel group, two-arm randomized trial among 500 Black kidney transplant candidates. After Blacks are placed on the waiting list for a DDKT, we will randomly assign them to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a culturally sensitive, group-based intervention. Participants randomized to the Intervention will be asked to attend a 60-90 minute small group seminar (family and friends strongly encouraged to attend) that will feature brief talks regarding: basic facts about CKD, transplant, and the waiting list; basic facts about live kidney donation; the experience of receiving a transplant and LDKT; the experience of serving as a live kidney donor; and skill-building regarding how to ask for a live donor. These talks will directly address the barriers that impede LDKT. Physicians and Black LDKT recipients and live donors will lead these talks, supplemented by educational videos. In our preparatory aim, we will develop the Intervention and train the speakers. Our primary aim will compare LDKT readiness and LDKT receipt in the Intervention vs. Usual Care groups of our randomized clinical trial; our primary outcome is change in readiness to pursue LDKT, and our main secondary outcome is actual receipt of LDKT, after 18 months of follow-up. Our secondary aims will determine (a) the social and behavioral variables that modify the effect of the Intervention upon LDKT readiness and receipt; and (b) whether changes in social and behavioral factors mediate the effect of the Intervention upon LDKT readiness and receipt. This clinical trial will occur at two neighboring transplant centers that share the same policies, procedures, and personnel. In an average year, these two centers combine to place over 200 Blacks on the DDKT waiting list and perform over 135 LDKTs (including ~29 among Blacks). By intervening upon patients "distal" in the transplant process, at two centers that perform many LDKTs, we have excellent power to detect a beneficial effect of the Intervention upon LDKT readiness and receipt. At the end of this study, we will have developed and tested a culturally sensitive educational and behavioral Intervention that has the potential to increase receipt of LDKT among Blacks and decrease the striking racial disparities in receipt of LDKT.
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