Trial Summary
Importance: Patients 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.
Objective: To evaluate the effect of a multi-component quality improvement intervention designed to help eligible patients complete key steps toward receiving a kidney transplant.
Design, setting, and participants: A pragmatic, two-arm, parallel-group, open-label, registry-based, superiority, cluster-randomized trial (November 1, 2017, to December 31, 2021). The trial included all 26 CKD programs in Ontario. These programs care for patients approaching the need for or receiving maintenance dialysis.
Intervention: Using stratified, covariate-constrained randomization, we allocated the CKD programs (1:1) to provide the intervention or usual care for 4.2 years. The intervention had 4 main components: (1) administrative support to establish local teams to drive performance; (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.
Primary outcome: Total steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant centre for evaluation; step 2, had a potential living donor contact a transplant centre for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.
Results to date: The 26 CKD programs (13 intervention, 13 usual care) cared for 20,375 potentially transplant-eligible patients with advanced CKD (intervention [n=9780 patients], usual care [n=10 595 patients]). The provincial core operations group met over 100 times during the trial. Each of the 13 CKD programs established a local quality improvement team, developed a charter with their goals and activities, and indicated that team members met regularly to review and improve transplant performance. Together, the programs reported that 1740 patients completed the educational program Explore Transplant Ontario (etontario.org). Transplant ambassadors (prior kidney transplant recipients and living kidney donors) recorded 5471 meaningful interactions with patients with advanced CKD and 719 meaningful interactions with potential living kidney donors (transplantambassadors.ca). Each CKD program received regular performance reports and had annual performance meetings with the provincial renal agency. We are currently analyzing and preparing the results for publication.
