Education Intervention for Evaluation and Living Donor Kidney Transplantation: A randomized trial.

Background: Kidney transplantation (KT) evaluation is a complex, lengthy process; and living donor KT (LDKT) is the optimal treatment for kidney failure. Interventions at the start of evaluation may improve evaluation completion and LDKT rates. This study tested whether (a) an educational booklet and video (the "Talking About Living Kidney donation" [TALK] intervention) increased evaluation completion and LDKT when delivered under a streamlined KT evaluation program; and (b) if no effects found, explore differential effects by psychosocial/sociocultural factors (e.g., healthcare-related discrimination). Methods: We conducted a randomized-controlled trial of the TALK intervention using permuted block randomization at an urban transplant center. Participants were enrolled 05/2015-06/2018; follow-up through 08/2022. Staff were blinded to block size, not allocation. Fine-Gray proportional hazards models examined intent-to-treat and per-protocol approaches. Primary outcomes were the cumulative incidence of evaluation completion and LDKT receipt. We explored interaction analyses by psychosocial/sociocultural factors and TALK-assignment. Results: Among 1108 participants (574 [52%] TALK, 534 [48%] No-TALK; median age: 59.13 [IQR: 48.92-67.10]; 243 [22%] Black, 783 [71%] White, 82 [7%] Other; 695 [63%] male), TALK did not significantly improve evaluation completion (sub-distribution hazard [SHR]=1.06; 95% CI: 0.92-1.22) or LDKT receipt (SHR=0.83; 95% CI: 0.55-1.25) in intent-to-treat and per-protocol analyses. In exploratory per-protocol analyses, discrimination significantly modified the effect of TALK on evaluation completion (SHR=0.42; 95% CI: 0.29-0.61). The "No-Discrimination" TALK participants had greater evaluation completion than No-TALK (SHR=1.32; 95% CI: 1.10-1.58), but the "Discrimination" TALK participants had lower evaluation completion than No-TALK (SHR=0.56; 95% CI: 0.41-0.77). Conclusions: Despite streamlined care, TALK did not improve evaluation completion or LDKT rates. A significant interaction in the per-protocol analyses for evaluation completion suggests prior healthcare-related discrimination may limit educational intervention effectiveness. Future studies should explore approaches that address systemic barriers and complement, rather than rely on, educational strategies to promote LDKT (ClinicalTrials.gov Identifier: NCT02342119).