Key Points

In a randomized trial, an educational booklet and video did not increase evaluation completion or living donor kidney transplant receipt.

For patients who received the booklet and video intervention, experiencing discrimination in healthcare reduced evaluation completion.

Long-term follow-up and a large sample size yielded sufficient power to validate a true null effect of the intervention on key outcomes.

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).

The authors have declared no competing interest.

NCT02342119

https://doi.org/10.1016/j.cct.2016.11.011

Funding/Support: This work was supported in part by grants R01DK081325 from the National Institute of Diabetes and Digestive and Kidney Diseases (PI: L. Myaskovsky); UL1TR001857 from the National Center for Advancing Translational Sciences in part to Dr. Myaskovsky (PI: S. Reis); T32HL007736 from the National Heart, Lung, and Blood Institute in part to Dr. Velez-Bermudez (PI: T. Resta); and C-3924 from Dialysis Clinic Inc (PI: L. Myaskovsky).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Boards at the University of Pittsburgh (PRO09060113) and the University of New Mexico (17-084) gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Dr. Larissa Myaskovsky had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The data are not publicly available due to privacy or ethical restrictions.