An interventional study of Digital Health Integration and Training for Early Transplant Access and Support in Kidney Disease, Kidney Transplant and Deceased Donor Kidney Transplant, sponsored by The Methodist Hospital Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by The Methodist Hospital Research Institute · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
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.
Behavioral: Digital Health Integration
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.
Behavioral: Training for Early Transplant Access and Support
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.
Behavioral: Kidney Health Mobile Health (mHealth) Application
Enhance practice-based performance reports and dashboards to continuously monitor, incorporate and track changes in transplant metrics.
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.
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
Referral to Transplant
The primary clinical outcome is any referral to transplant within the study period. The chi-square test will be used to compare the primary outcome between the treatment arms. Next, GLMM models will be constructed to test whether the treatment effect is significant between the two arms, using a logit link function for equation 1. The model will allow investigators to include relevant patient characteristics, as well as provider- and site-level random effects to account for correlation within clinicians or sites, because individual visits within a provider/site are often more similar in their outcomes than others. The level and difference-in-difference parameters will be interpreted and reported as odds ratios, with corresponding 95% confidence limits. Investigators will apply a similar methodology for secondary outcomes.
Time frame: Baseline to 12-months
Level of transplant knowledge
At the level of patient and support-network, knowledge gaps related to kidney transplant will be addressed by providing access to educational topics (CKD care basics, renal replacement options available, transplant and living donor evaluation processes, etc.) via the mHealth application. For continuous outcomes, GLMM with the covariates and the site-level random-effects described above for the primary outcome will be used to estimate the pre- vs. post-implementation level differences. Depending on the probability distribution of the outcome variables, investigators will use identity or log link functions as appropriate.
Time frame: Baseline to 12-months
Attendance at KPSC Education Classes
For the binary outcomes, such as attendance at education classes, the same analytic scheme as described above for the primary outcome will be used to evaluate the intervention effects.
Time frame: Baseline to 12 months
Deceased or Living Donor Kidney Transplant Rates
Time frame: Baseline to 12-months
Wait-listing Rates
Time frame: Baseline to 12-months
Number of KPSC Nephrology Visits
Time frame: Baseline to 12-months
Plan to share: No
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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