source : www.medpagetoday.com
PHILADELPHIA – A multi-component intervention in Canada designed to overcome barriers to kidney transplantation and living donation failed to increase access to both.
Despite the high rate of interventions among the patients randomized to that group, they did not have a greater completion rate of four key, predefined steps toward receiving a kidney transplant than the usual care group, reported Amit X. Garg, MD, PhD, at the American Society of Nephrology Kidney Week and online JAMA Internal Medicine.
After a median follow-up of 2.1 years, 2,063 participants in the intervention arm versus 2,152 in the control arm were referred to a transplant center (adjusted HR 1.00, 95% CI 0.87-1.15). Donor ratings were also statistically similar between groups (aHR 1.22, 95% CI 0.97-1.54), as were the number of transplants received (aHR 1.11, 95% CI 0.57-2.15), respectively .
“We have a serious problem in kidney care,” says Garg of Western University in London, Ontario. “Patients with advanced chronic kidney disease (CKD) have the best chance at a longer, healthier life if they receive a kidney transplant. Every 100 kidney transplants save the health care system $20 million over five years, primarily through avoided dialysis costs. And yet, because of many barriers, many eligible patients today will never receive a transplant.”
In an invited commentary accompanying the study, L. Ebony Boulware, MD, MPH, of Wake Forest University in Winston-Salem, North Carolina, wrote that “the long-standing conundrum of poor access to kidney transplantation can only be solved through systems Garg et al.’s findings suggest that promising systems approaches to addressing kidney transplantation are potentially effective and practical, but may also be challenging to implement and sustain in a clinical setting.’
The multi-component intervention targeted barriers that prevent kidney transplantation and living donation by providing:
- Administrative support to a central operations group for each program to establish a local quality improvement team
- Educational tools for healthcare professionals, patients and potential donors
- Patient support through former recipients and living donors who spend time in kidney programs to share their experiences
- Reports detailing how patients from each program completed the steps toward receiving a transplant
The trial included all 26 kidney programs providing advanced CKD care in Ontario, managed by a publicly funded provincial kidney agency. The study used covariate restricted cluster randomization to assign 13 of the 26 renal programs to the intervention or usual care.
Patients aged 18 to 75 years with no contraindication to transplantation (e.g., no evidence of home oxygen use, residence in a long-term care facility, certain cancers, or very high comorbidity) were enrolled in the study once they had persistent evidence of an estimated glomerular disorder. filtration rate (eGFR) <15 ml/min/1.73 m22a predicted probability of at least 25% of receiving renal replacement therapy within 2 years, or undergoing outpatient maintenance dialysis in a center or at home.
During the trial period, 9,780 patients entered the multicomponent arm and 10,595 entered the usual care arm. About half of each group were approaching the need for dialysis but had not yet started it. Few patients switched between the two groups. Of the group approaching dialysis, 48% started dialysis during the trial period, with the percentage being similar between the two groups.
The groups were well balanced in terms of baseline characteristics at the program and patient levels. The mean age of the patients was 61 years; 38% were women.
No significant difference was detected between the two groups in any step towards transplantation examined individually or in combination in different subgroups or in the number of living kidney donor transplants. The percentage of patients who completed at least one step, at least two steps, at least three steps, and four steps toward transplantation during the trial period did not differ between the two groups.
“The onset of the pandemic, 2.4 years after the start of the trial period, had a significant impact on intervention delivery for at least a year,” Garg said. Quality improvement teams met less frequently, provincial rounds were paused, healthcare workers were redeployed and transplant ambassadors switched from in-person to virtual meetings. Referrals, donor assessments and transplants were also delayed.
Still, Boulware noted, the study showed that “stakeholder-approved interventions could be successfully deployed simultaneously in chronic kidney disease clinics, home dialysis, and in-center dialysis centers, providing a model for other systems and future studies based on systems based strategies to improve access to kidney transplants.”
Garg noted that despite the neutral results, “we believe several aspects of our systems approach remain sensible.”
His group is working on a process evaluation to optimize their future approach. “Some early data suggests better integration of different aspects, more healthcare resources for interventions, better retraining of transitioning staff, and making it clear who is responsible (for what) could lead to future success,” he said.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care.
Garg is an employee of the London Health Sciences Center. He reported research funding from Astellas and Baxter and served on the editorial board Kidney International and the American Journal of Kidney Disease.
Boulware reported no disclosures.
JAMA Internal Medicine
Source reference: Garg AX, et al. “Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplantation and Living Kidney Donation” JAMA Intern Med 2023; DOI: 10.1001/jamainintermed.2023.5802.
JAMA Internal Medicine
Source reference: Boulware LE “Solving the Kidney Transplant Problem through Systems Thinking” JAMA Intern Med 2023; DOI: 10.1001/jamainintermed.2023.5818.
source : www.medpagetoday.com