Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial

• Authors: Stephanie N Dixon, Lawson Health Research Institute; Kyla L Naylor, Lawson Health Research Institute; Seychelle Yohanna, McMaster University; Susan McKenzie, Grand River Hospital; Dmitri Belenko, University of Toronto; Peter G Blake, Ontario Health; Candice Coghlan, University Health Network University of Toronto; Rebecca Cooper, Ontario Health; Lori Elliott, Ontario Health; Leah Getchell, Lawson Health Research Institute; Vincent Ki, Ontario Health; Istvan Mucsi, University of Toronto; Gihad Nesrallah, University of Toronto; Rachel Patzer, Emory University; Justin Presseau, Ottawa Hospital Research Institute; Marian Reich, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (CAN-SOLVE CKD); Jessica M Sontrop, Lawson Health Research Institute; Darin Treleaven, McMaster University; Amy D Waterman, Houston Methodist Hospital; Jeffrey Zaltzman, Ontario Health; Amit X Garg, Lawson Health Research Institute
• Journal Title: Canadian Journal of Kidney Health and Disease
• Volume: Volume 9
• Publisher: (publisher) | 2022-01-01, Pages 20543581221131201-20543581221131201
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1177/20543581221131201
• Subjects: Health Sciences, Medicine and Surgery; Health Sciences, Epidemiology
• Keywords: cluster-randomized clinical trial; kidney transplantation; living kidney donation; quality improvement intervention; statistical analysis plan

Abstract

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the “clusters”). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the “registry”). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (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. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521). Statistical Analytic Plan: Version 1.0 August 26, 2022.