Digital Tools for Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people with chronic kidney disease or kidney failure who are considering a transplant. It aims to include patients at different stages of kidney disease, especially those who may benefit from learning about and pursuing a kidney transplant.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Digital Health Integration
- Kidney Health Mobile Health (mHealth) Application
- Training for Early Transplant Access and Support
Trial Overview
The study tests a new approach using digital health tools, special training for early access to transplants, and a mobile app that helps patients learn about transplants, connect with support networks, and find living donors. The goal is to improve transplant rates compared to usual care.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Interventions at the health system level include expanding use of telehealth, mHealth, and health information technology to increase opportunities for enhanced care and education and enhancing practice-based performance reports and dashboards detecting high risk patients, flagging missing test results, and tracking key transplant metrics.
Intervention activities include teaching providers how to support transplant referral earlier and increasing referring patients and families to transplant educational resources including KPSC transplant classes, the mHealth application, and peer support networks. Additional clinician-targeted activities will include educational programs, training on use of key CKD tools (e.g., the Tangri risk score) and training in patient and donor support activities and brief interventions.
A kidney health-specific mHealth mobile application, is being designed to educate, empower, and engage CKD patients, their support networks, and potential living donors. It allows patients and their support to choose to learn about educational topics most interesting to them and to answer follow-up questions to show mastery of content (e.g., the basics of CKD care, all renal replacement options, the transplant and living donor evaluation processes). To empower patients, the mHealth application incorporates in-app support groups and messaging to foster peer support and create a community of encouragement. It also includes video stories of patients and living donors receiving transplants and donating a kidney through the Living Donation Storytelling Project and allows users the opportunity to film their own stories about their need for a living donor. The app will provide decision aids and tools to help patients find a living kidney donor and refers them to financial resources.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
Kaiser Permanente
Collaborator
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