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

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.

Particip

SUBMITTER: Dixon SN 

PROVIDER: S-EPMC9693773 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature