Grand Rounds March 29, 2024: Effect Of A Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD, MSc)

Posted on by Lauren Stewart

Speakers

Amit Garg, MD, MA (Education) FRCPC, FACP, PhD
Associate Dean, Clinical Research, Schulich School of Medicine and Dentistry
Lead, Institute for Clinical Evaluative Sciences Kidney, Dialysis and Transplantation Provincial Program
Director, Institute for Clinical Evaluative Sciences (ICES) Western Facility
Nephrologist, London Health Sciences Centre
Professor, Medicine, Epidemiology & Biostatistics, Western University 

Stephanie N. Dixon, PhD MSc
Staff Scientist, Institute for Clinical Evaluative Sciences Kidney, Dialysis and Transplantation Research Program
Biostatistician, London Health Sciences Centre

Keywords

Cluster-randomized; Kidney disease; Transplant; Outcomes

Key Points

  • For patients with kidney failure, a kidney transplant is proven to offer patients a better quality of life and is more cost effective for health care systems than dialysis over time. However, there are many barriers preventing eligible patients from receiving a kidney transplant.
  • EnAKT LKD is a cluster randomized trial that sought to improve access to transplants in order to determine whether renal program-wide use of a multicomponent intervention is superior to usual care through 4 key steps: referral, donor evaluation, waitlist, and transplant. This multicomponent intervention was designed to address several barriers that prevent kidney transplantation and living donation through providing administrative support, educational resources, patient support groups, and performance reports.
  • During 4.2-year trial period, 10,000 patients eligible for a kidney transplant between the ages of 18-75 entered each of the two trial arms. Half of these patients were approaching a need for dialysis.
  • In conducting the statistical analysis of a trial, it’s especially important to consider the types of outcomes, as well as how they are collected to incorporate into the analysis. In the EnAKT LKD trial, the primary outcome is completing 4 unique key steps toward receiving a kidney transplant.
  • The primary outcome was analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. The multistate model allowed the researchers to start patients at different steps in the process upon enrollment in order to more accurately reflect where they are on their transplant journey. One of the limitations of this model is that it assumes that once a patient moves into a new state, they are no longer in the previous state. In order to address this limitation, researchers can expand the multistate framework to allow for different baseline hazards to be associated with the different transitions between states, creating a step completion history for each patient that evaluates their experiences in each step of the process.
  • Although researchers observed evidence of multicomponent intervention uptake through each of the 4 intervention components, the rate at which patients completed each of the 4 key steps to receiving a kidney transplant did not significantly differ between the intervention and usual-care groups.
  • The trial investigators are working toward a modified approach to addressing the important issue of access to transplantation.

Learn More

Read more in JAMA.

Learn about the Pragmatic Trials Training Program.

Discussion Themes

-Essentially all the potential upside that you were aiming for in this trial was to increase the number of living kidney donors, correct? Yes, that is correct. In order to meet the demand for kidney transplant, the World Health Organization and other agencies have increased the amount of living donor transplants. Unfortunately, this is a complex issue with a number of steps. There are health care systems issues. It’s difficult to get people to come forward to donate a kidney. Those are the various barriers we’re trying to address through this trial.

-Why did you choose to measure total transplantation rather than those from living donors as your outcome? For the primary analysis, we counted all transplants, and we certainly looked at living donor transplants separately in additional outcomes. The reason for that is we were trying to activate the intervention. For example, for referral for transplant, that might not result in a living donor transplant but might result in a kidney donor transplant, particularly for people who were enrolled earlier in the trial. We acknowledge that given the wait times, the biggest impact we were hoping for was a living donor transplant.

 

Tags

#pctGR, @Collaboratory1