Explore Transplant @Home Within Kaiser Permanente Southern California

NCT03389932 | Completed

• 1 other identifier: R39OT29879
• Study Type: interventional
• Target: 977
• Locations: 1 country
• Sites: 1

Brief Summary

Today, there are 25 million Americans with chronic kidney disease (CKD) and 660,000 patients in full kidney failure, the final CKD stage, known as end stage renal disease (ESRD). Over half of ESRD patients are Black, Hispanic, or Asian. ESRD patients must either receive regular dialysis treatments, by which waste is filtered from the blood by a machine, or a kidney transplant from a deceased or living donor. Five-year survival on dialysis is only 40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living donor kidney transplant (LDKT). Despite the known health benefits of DDKT and LDKT, 70% of ESRD patients remain on dialysis, especially ethnic/racial minorities. An American Society of Transplantation (AST) Consensus Conference recently recommended that patients in all CKD stages should have the opportunity to learn about and decide which treatment option is right for them, particularly about LDKT. However, early education about LDKT and DDKT is inconsistent and often poor, with early stage CKD patients and ethnic/racial minorities even less likely to receive it. Through previous HRSA grants, Dr. Waterman designed the Explore Transplant@Home (ET@Home) video-guided education program, and found that it significantly increased LDKT knowledge and informed decision-making for Black and White dialysis patients in Missouri when delivered by mail and supported through bimonthly postcards and texting. Now based at the University of California, Los Angeles (UCLA), she has partnered with Kaiser Permanente Southern California (KPSC), an integrated learning healthcare system providing insurance coverage and comprehensive care to 65,000 patients in CKD Stages 3, 4 and 5 (ESRD) (24% Hispanic, 52% White, 15% Black, and 9% Asian; 10% Spanish-speaking).

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge

  Patients will be asked true/false and multiple choice questions to determine their level of knowledge regarding basic facts, advantages, risks and outcomes of DDKT and LDKT (e.g., "Patients older than 75 years can receive transplants"; "Compared to transplants from donors who have died, how long do transplants from living donors last?"). Scores for this scale are created by summing the number of correct answers given by the patient, creating a theoretical range of 0-25 with higher scores indicating more knowledge.

  6 months

Secondary Outcomes (2)

• Decisional Balance

  6 months

• Informed Decision-Making

  6 months

Study Arms (2)

Standard of Care (Control)

NO INTERVENTION

For patients who are randomized to the control condition and who are or become potentially eligible for transplant during their enrollment in the study, they will not receive any additional interventions during the study period. Patients in this condition will only receive the education that is administered by the KPSC Kidney Transplant Program and will not receive any educational materials designed for the intervention group of this study.

Patient-Guided

EXPERIMENTAL

Patients in the ET@Home study condition will receive four modules of video and print transplant education over a 6-month period. After each module is mailed, 3 postcards are mailed weekly that recap important transplant educational content covered within the videos. Patients will have the opportunity to participate in a texting component of ET@Home that also sends small pieces of educational content and learning reminders by phone each week.

Behavioral: Patient-Guided

Interventions

Patient-Guided BEHAVIORAL

Patients in the ET@Home study condition will receive four modules of video and print transplant education over a 6-month period. After each module is mailed, 3 postcards are mailed weekly that recap important transplant educational content covered within the videos. Patients will have the opportunity to participate in a texting component of ET@Home that also sends small pieces of educational content and learning reminders by phone each week.

Patient-Guided

Eligibility Criteria

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

You may qualify if:

• Participant must be at least 18 years of age.
• Participant must self-identify as African American, White, Hispanic, or Asian.
• Participant must currently be classified as having CKD 3, 4 or 5.
• Participant must be able to speak and read in English or Spanish.

You may not qualify if:

• Participant is not classified as having CKD 3,4, or 5.
• Participant cannot speak or read in English or Spanish.

Sponsors & Collaborators

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

Study Sites (1)

Kaiser Permanente Research and Evaluation

Pasadena, California, 91101, United States

Location

Related Publications (1)

• Waterman AD, Anderson C, Alem A, Peipert JD, Beaumont JL, Henry SL, Dub B, Ambriz L, Bijjala N, Lipsey AF, Mittman B. A randomized controlled trial of Explore Transplant at Home to improve transplant knowledge and decision-making for CKD 3-5 patients at Kaiser Permanente Southern California. BMC Nephrol. 2019 Mar 4;20(1):78. doi: 10.1186/s12882-019-1262-9.

  PMID: 30832619 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Patient Engagement, Diversity, and Education

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 4, 2018
• Study Start: July 11, 2018
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2025
• Last Updated: May 22, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)