Strategies to Transform Kidney Care and Improve Pursuit of Transplant

NCT07794631 | Active Not Recruiting

• 2 other identifiers: PRO000353701R01HS028655-01A1
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12-months

Secondary Outcomes (5)

• Level of transplant knowledge

  Baseline to 12-months

• Attendance at KPSC Education Classes

  Baseline to 12 months

• Deceased or Living Donor Kidney Transplant Rates

  Baseline to 12-months

• Wait-listing Rates

  Baseline to 12-months

• Number of KPSC Nephrology Visits

  Baseline to 12-months

Study Arms (3)

System Level

OTHER

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

Provider Level

OTHER

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

Patient and Support System Level

OTHER

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

Interventions

Digital Health Integration BEHAVIORAL

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

System Level

Training for Early Transplant Access and Support BEHAVIORAL

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.

Provider Level

Kidney Health Mobile Health (mHealth) Application BEHAVIORAL

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

Patient and Support System Level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older
• Patients in CKD Stage 3b, 4 or ESKD
• English or Spanish-speaking

You may not qualify if:

• Contraindications to transplant

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Interventions

Palliative Care; Telemedicine

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The stepped wedge cluster randomized controlled trial will be conducted in 12 KPSC medical centers with 660 CKD patients each (CKD Stages 3b (high risk) - ESKD) to be sequentially rolled out in three groups of four KPSC centers at a time until all centers receive the multilevel intervention. Prior to randomization, facilities will be matched to create four groups of three similar facilities based on key facility characteristics hypothesized to be associated with intervention effectiveness and implementation success186, such as patient volume, staffing patterns and other CFIR Internal Setting variables; geographic region and service area type (urban, suburban, rural), and other External Context variables. Matching and creation of groups will be conducted using an SAS algorithm.186 Within each group of three closely-matched facilities, each facility will be randomly assigned to either cluster (step) 1, 2 or 3 to determine when each facility will begin the implementation phase.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: August 31, 2026
• Study Start: August 15, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)