Strategies to Transform Kidney Care and Improve Pursuit of Transplant

Chronic Kidney Disease (Stages 3b-5), Deceased Donor Kidney Transplant, Kidney Disease, Kidney Transplant, Living Donor Kidney Transplantation

Approximately 15% of the U.S. population has chronic kidney disease, and \ 700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the standard of care continues to be ongoing dialysis, which has poor clinical outcomes in comparison to LDKT and DDKT. Best practices to transform kidney care recommended by the Centers for Medicare and Medicaid Services (CMS), the American Society of Nephrology (ASN) and the 2019 Executive Order Advancing American Kidney Health Initiative include earlier detection of patients whose kidneys are deteriorating rapidly, introducing transplant as a potential treatment option earlier, optimally before their kidneys fail, improved dissemination of health literate transplant education tools, often through digital technology or mHealth, and increasing LDKT rates by helping patients locate living donors or motivating others to donate. Barriers at the patient-, support network-, clinician- and system-levels of the Socio-Ecological Model persist, including poor identification of high-risk patients, insufficient clinician time to discuss transplant, poor transplant knowledge, reluctance or insufficient support to ask living donors to donate, and disengaged friends and relatives, some of whom who might become living donors. While extensive policy and intervention efforts are underway, none have achieved significant increases in pursuit and receipt of transplant, especially LDKT rates. In 2017, Kaiser Permanente Southern California (KPSC), an integrated care system serving 24,000 CKD patients, partnered with the Transplant Research and Education Center (TREC) at Houston Methodist Research Institute (HMRI) and J.C. Walter Jr. Transplant Center Houston Methodist Hospital (HMH) to launch a multi-year plan for transforming CKD and ESKD care. Investigators now propose to conduct a pragmatic stepped wedge cluster randomized trial of a novel multilevel intervention to improve CKD and ESKD care, improve transplant rates and reduce disparities. One innovative component of the multilevel intervention is a state-of-the-art technology-supported mHealth application, developed in partnership with patients, to engage patients, family members, and potential living donors to improve their CKD knowledge, view transplant success stories, and seek kidney-related support to pursue transplant, including learning how to find living donors. Investigators also seek to identify moderators at various socio-ecological levels, especially factors influencing variations in effectiveness across different settings and among underserved patient subgroups known to have reduced access to transplant and build implementation tools to increase access to and pursuit of transplant within large integrated health systems including comparable systems (commercial, academic, safety net) across the U.S.

This study will evaluate an innovative multilevel transplant intervention delivered within KPSC, an integrated CKD healthcare delivery system, for earlier stage patients not yet in kidney failure (Stage 3b and 4) as well as for patients whose kidneys have failed. The intervention will target patients, their support networks, potential donors, KPSC clinicians, and the KPSC system as a whole. It will integrate an innovative mHealth CKD education application with updated KPSC CKD care process to educate, empower, and engage patients, potential living donors, and family members in learning more about and pursuing transplant and living donation. The intervention will be activated across the system by KPSC CKD clinical leadership, with all research and educational components led by the study PIs. Investigators will assess effects of the multilevel intervention on the primary outcome, referral for transplant, and on secondary outcomes including attendance at KPSC education classes, KPSC nephrology visits, level of patient transplant knowledge, wait-listing rates, and DDKT/LDKT rates. Investigators will further analyze trial results, examining heterogeneity of treatment effects and mechanisms of effect. This study operates under a reliance agreement, with KPSC being the reviewing IRB of record.

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United States