A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial

• Type of Material: Article
• Authors: Seychelle Yohanna, McMaster University; Kyla L Naylor, Institute for Clinical Evaluative Sciences; Istvan Mucsi, University of Toronto; Susan McKenzie, Grand River Hospital; Dmitri Belenko, University of Toronto; Peter G Blake, Western University; Candice Coghlan, Grand River Hospital; Stephanie N Dixon, Institute for Clinical Evaluative Sciences; Lori Elliott, Ontario Health; Leah Getchell, London Health Sciences Centre; Vincent Ki, Ontario Health; Gihad Nesrallah, Ontario Health; Rachel Patzer, Emory University; Justin Presseau, Ottawa Hospital Research Institute; Marian Reich, Patient Council; Jessica M Sontrop, Western University; Darin Treleaven, McMaster University; Amy D Waterman, University of California, Los Angeles; Jeffrey Zaltzman, Trillium Gift of Life Network; Amit X Garg, Institute for Clinical Evaluative Sciences
• Language: English
• Date: 2021-01-01
• Publisher: SAGE Publishing
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2021
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1177/2054358121997266
• Title of Journal or Parent Work: Canadian Journal of Kidney Health and Disease
• Volume: 8
• Start Page: 2054358121997266
• End Page: 2054358121997266
• Grant/Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This trial is funded/sponsored by the ORN (part of Ontario Health) and the Canadian Institutes of Health Research (CIHR) SPOR Networks in Chronic Disease (Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease [Can-SOLVE CKD]). The Lawson Health Research Institute was a sponsor for this work. Partial funding to deliver the Explore Transplant Ontario educational program was provided by Astellas Pharma Canada Inc. A.X.G. is supported by the Dr. Adam Linton Chair in Kidney Health Analytics and is the joint ORN-TGLN Provincial Medical Lead for Access to Kidney Transplantation. He is also supported by a Clinician Investigator Award from the Canadian Institutes of Health Research.
• Keywords: living kidney donation; cluster-randomized clinical trial; protocol; kidney transplant; quality improvement intervention
• Research Categories: Health Sciences, Epidemiology; Biology, Biostatistics

Abstract

Background: Many patients with kidney failure will live longer and healthier lives if they receive a kidney transplant rather than dialysis. However, multiple barriers prevent patients from accessing this treatment option. Objective: To determine if a quality improvement intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps toward receiving a kidney transplant. Design: This protocol describes a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial—the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Setting: All 26 CKD programs in Ontario, Canada, with a trial start date of November 1, 2017. The original end date of March 31, 2021 (3.4 years) has been extended to December 31, 2021 (4.1 years) due to the COVID-19 pandemic. Participants: During the trial, the 26 CKD programs are expected to care for more than 10 000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant. Intervention: Programs were randomly allocated to provide a quality improvement intervention or usual care. The intervention has 4 main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Primary Outcome: The primary outcome is the number of key steps completed toward receiving a kidney transplant analyzed at the cluster level (CKD program). The following 4 unique steps per patient will be counted: (1) patient referred to a transplant center for evaluation, (2) at least one living kidney donor candidate contacts a transplant center for an intended recipient and completes a health history questionnaire to begin their evaluation, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor. Planned Primary Analysis: Study data will be obtained from Ontario’s linked administrative healthcare databases. An intent-to-treat analysis will be conducted comparing the primary outcome between randomized groups using a 2-stage approach. First stage: residuals are obtained from fitting a regression model to individual-level variables ignoring intervention and clustering effects. Second stage: residuals from the first stage are aggregated at the cluster level as the outcome. Limitations: It may not be possible to isolate independent effects of each intervention component, the usual care group could adopt intervention components leading to contamination bias, and the relatively small number of clusters could mean the 2 arms are not balanced on all baseline prognostic factors. Conclusions: The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement intervention helps patients complete more steps toward receiving a kidney transplant. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.