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PHILADELPHIA -- A multicomponent intervention in Canada designed to overcome barriers that prevent kidney transplantation and living donation failed to increase access to either.

Despite a high rate of intervention uptake among the patients randomized to that group, they had no greater rate of completion of four key predefined steps toward receiving a kidney transplant than did the usual care group, reported Amit X. Garg, MD, PhD, at the American Society of Nephrology Kidney Week and online in .

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 evaluations were also statistically similar between groups (aHR 1.22, 95% CI 0.97-1.54), as was the number of transplants received (aHR 1.11, 95% CI 0.57-2.15), respectively.

"We have a serious problem in kidney care," said Garg, of Western University in London, Ontario. "Patients with advanced chronic kidney disease [CKD] have the best chance for a longer and healthier life if they receive a kidney transplant. Every 100 kidney transplants save the healthcare system $20 million over 5 years, primarily from averted dialysis costs. And yet, due to many barriers, many eligible patients today will never receive a transplant."

In an that accompanied 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 transplant will only be solved through systems thinking. The findings of Garg et al suggest that promising systems approaches to addressing kidney transplant are potentially effective and practical, but they may also be challenging to implement and sustain in clinical settings."

The multicomponent intervention was aimed at barriers that prevent kidney transplantation and living donation by providing:

• Administrative support from a central operations group for each program to establish a local quality improvement team
• Educational resources for health professionals, patients, and potential donors
• Patient support via past recipients and living donors spending time in renal programs to share their experiences
• Reports detailing how each program's patients were completing the steps toward receipt of a transplant

The trial included all 26 renal programs that provide advanced CKD care in Ontario under management by a government-funded provincial renal agency. The trial used covariate constrained cluster randomization to allocate 13 of the 26 renal programs to the intervention or usual care.

Patients ages 18 to 75 years with no contraindication to transplant (e.g., no evidence of home oxygen use, residence in a long-term care facility, select cancers, or very high comorbidity) entered the trial once they had persistent evidence of an estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m², at least a 25% predicted chance of receiving renal replacement therapy within 2 years, or were receiving outpatient maintenance dialysis in a center or at home.

During the trial period, 9,780 patients entered the multicomponent arm and 10,595 the usual care arm. About half in each group were approaching the need for dialysis but had not yet started it. Few patients crossed over between the two groups. Of the group approaching dialysis, 48% started dialysis during the trial period, with a rate that was similar between the two groups.

Groups were well balanced for program- and patient-level baseline characteristics. Mean age of patients was 61 years; 38% were women.

No significant difference was detected between the two groups in each step toward transplantation examined in isolation or in combination in different subgroups or in the rate of living kidney donor transplants. The proportion 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 start of the pandemic 2.4 years into the trial period substantially impacted intervention delivery for at least a year," said Garg. Quality improvement teams met less often, provincial rounds were paused, healthcare staff were redeployed, and transplant ambassadors shifted from in-person to virtual meetings. Referrals, donor evaluations, and transplants were also delayed.

Even so, Boulware noted, the study demonstrated that "stakeholder-endorsed interventions could be successfully deployed across CKD clinics, home dialysis and in-center dialysis settings simultaneously, providing a model for other systems and future studies seeking to implement 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 through a process evaluation to optimize their future approach. "Some early data suggest better integration of different aspects, more healthcare resources for intervention delivery, better retraining for personnel who turn over, and making it clear who is accountable [for what] may lead to future success," he said.