Strategies to Transform Kidney Care and Improve Pursuit of Transplant

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

Digital Health Integration

Enhance practice-based performance reports and dashboards to continuously monitor, incorporate and track changes in transplant metrics.

BEHAVIORAL

Training for Early Transplant Access and Support

Teach providers how to support transplant referral earlier with patients and how to find living donors. Increase referrals to and patients' use of mHealth technology, transplant education sessions, and kidney support networks.

BEHAVIORAL

Kidney Health Mobile Health (mHealth) Application

Adapt the mHealth app in order to: Educate and engage CKD patients and their support networks in learning about and taking transplant actions and becoming living donor advocates; Use video technology to capture and view real-life transplant and living donor success stories; Teach patients how to find living donors; Refine KPSC transplant education sessions to align with mHealth technology to support the intended audience; Strengthen Kaiser kidney peer support networks and living donor advocates to synergize mentoring with mHealth. \*Note: mHealth is a generic name for the actual application

Sponsors & Collaborators

• Kaiser Permanente

  collaborator OTHER

• The Methodist Hospital Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-15

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• United States

Study Locations