Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation

Abstract

ImportancePatients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.ObjectivesTo evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.Design, Setting, and ParticipantsThis pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).InterventionsUsing stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.Main Outcomes and MeasuresThe primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.ResultsThe 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).Conclusions and RelevanceThis novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.Trial RegistrationClinicalTrials.gov Identifier: NCT03329521

Errors In Methods

“…In the recent article titled “Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: the EnAKT LKD Cluster Randomized Clinical Trial” published on November 3, 2023, in JAMA Internal Medicine , there were 2 misplaced citations in the Patent Support and Data and Accountability subsections. This article was corrected online.…”

Randomized Clinical Trials That Advance Health and Health Equity

“…Early and continued community partnership throughout the study ensures that the research question is solidly grounded by input from patients and clinicians who are at the frontlines of care, with study design and conduct decisions in every phase of the project reflecting shared leadership, responsibility, and commitment to reduce trial participation burden. In another example, the recent EnAKT LKD cluster RCT evaluated the effectiveness of a complex community– and health system–partnered intervention to improve access to kidney transplant. As stated in the Invited Commentary, the “intervention components and implementation strategies were informed by a robust community-informed stakeholder panel, ensuring interventions were tailored to regional needs.…”