Effect of an Intervention Designed to Improve Patient Access to Kidney Transplant

For patients with kidney failure, survival requires either ongoing dialysis treatment or a kidney transplant. Compared with dialysis, transplant is associated with improved quality of life and a possible gain of 10 or more years of life expectancy. In addition, over a 5-year period, transplant saves the health care system approximately $14.6 million USD, driven primarily by costs of dialysis. Compared with deceased donor kidney transplant, living donor transplants are associated with further advantages, including improved patient and graft survival. 

Nevertheless, many eligible patients do not receive a kidney transplant. According to Amit X. Garg, MD, and colleagues, the reasons for the care gap are complex, and include barriers for patients, families, health care professionals, chronic kidney disease (CKD) programs, transplant centers, and health care systems. 

Several countries have initiated interventions to address the barriers to care. Dr. Amit et al conducted the Enhance Access to Kidney Transplant and Living Donor Donation (EnAKT LKD) trial, a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant. Results were reported in JAMA Internal Medicine. 

The pragmatic, two-arm, parallel-group, open-label, registry-based, superiority cluster, randomized clinical trial included all 26 CKD programs in Ontario, Canada. The programs care for patients with advanced CKD who are approaching the need for dialysis or are already receiving maintenance dialysis. The trial period was November 1, 2017, to December 31, 2021.  

The intervention had four main components: (1) administrative support to establish a new local quality improvement team to manage local performance; (2) transplant education for health care staff, patients, and potential donors; (3) patient support in the form of transplant recipients and living donors sharing their experience; and (4) data and accountability, including program-level performance reports and oversight by administrative leaders. 

The primary outcome of interest was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to four steps, and for each patient, the researchers only counted each step once. The steps were: (1) referred to a transplant center for evaluation; (2) had a potential living donor contact a transplant center for evaluation (if multiple donors initiated evaluations, only the first donor counted); (3) added to the deceased donor waitlist; and (4) received a transplant from a living or deceased donor. 

There were five secondary outcomes that focused on living donor transplant: (1) donor evaluation or living donor transplant [step 2 or a subset of step 4]; (2) donor evaluation [step 2]; (3) referral and donor evaluation [steps 1 and 2]; (4) living donor transplant [subset of step 3]; and (5) preemptive living kidney donor transplant [a subset of step 4]. 

During the trial period, the 26 CKD programs cared for 20,375 patients with advanced CKD who were potential candidates for kidney transplantation. The intervention group included 9780 patients who entered the trial from 13 CKD programs, and the usual-care group included 10,595 patients from 13 CKD programs. All patients were included in the intention-to-treat analysis. 

The two groups were similar in both patient and center characteristics. Median age in the overall cohort was 61 years, 38% (n=7786) were women, and 57% (n=11,517) had a history of diabetes. At trial entry, 51% (n=10,025) were nearing the need for dialysis; the remaining 49% were receiving maintenance dialysis. In the group nearing the need for dialysis, median estimated glomerular filtration rate (eGFR) was 16 mL/min/1.73 m2, median random urine albumin-to-creatinine ratio was 162 mg/mmol, and the 2-year predicted risk of kidney failure was 45%. 

Among the patients who entered the trial on November 1, 2017, already receiving maintenance dialysis, median duration of dialysis was 2.6 years. Of the patients who entered the trial nearing the need for dialysis, 48% initiated maintenance dialysis during the trial. Prior to entering the trial, 80% of patients had completed no steps toward receiving a kidney transplant. 

During a median follow-up of 2.1 years, 1.4% (n=290) of the cohort emigrated from the province, 1.1% (n=225) recovered their kidney function, 13.7% (n=2789) became ineligible for a kidney transplant, and 16.8% (n=3432) died. The rates were similar in the two groups. Of the overall cohort, 5.4% of patients (n=484 in the intervention group [4.9%] and 621 in the usual care group [5.9%]) transferred to a CKD program in the alternate group. 

There was no significant difference in the rate of the primary outcome between the intervention group (n=9780) versus the usual-care group (n=10,595): 5334 steps versus 5638 steps, 24.8 versus 24.1 steps per 100 patient-years; adjusted hazard ratio (aHR), 1.00; 95% CI, 0.87-1.15. During follow-up, 1.3% of patients in the intervention group (n=130) completed all four steps, 5.8% (n=572) completed three or more, 15.3% (n=1493) completed two or more, and 32.1% (n=3138) completed one or more steps. In the usual-care group, the corresponding numbers were 1.2% (n=129), 5.6% (n=589), 14.5% (n=1538), and 31.9% (n=3382). 

For the five secondary outcomes focusing on living donor kidney transplant, there were no notable differences between the two groups. The rate of starting a living donor evaluation (step 2) for patients with CKD who did not have one prior to trial entry was numerically higher, but not notably different between the two study groups: 923 in the intervention group versus 920 in the usual-care group; 4.9 versus 4.4 evaluations per 100 patient-years; aHR, 1.22; 95% CI, 0.97-1.54. 

Limitations to the study cited by the authors included the impact of the COVID-19 pandemic on delivery of the intervention and a possible lessening of momentum for the initiative as health care priorities shifted to focus on the pandemic, and not addressing inequities in access to transplantation. 

In conclusion, the researchers said, “The findings of this randomized clinical trial did not show that a novel multicomponent intervention significantly increased the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.” 

Source: JAMA Internal Medicine