Explore Transplant @Home Within Kaiser Permanente Southern California

Today, there are 25 million Americans with chronic kidney disease (CKD) who are at risk for
kidney failure and 660,000 patients with end-stage renal disease (ESRD). To sustain life,
ESRD patients, among whom 31% are Black, 15% are Hispanic, and 5% are Asian, must either
receive daily or weekly dialysis treatments, by which waste is filtered from the blood by a
machine, or receive a kidney transplant from a deceased or living donor. Five-year survival
for patients on dialysis is only 40%, compared to 74% for patients who receive a deceased
donor kidney transplant (DDKT) and 87% for patients who receive a living donor kidney
transplant (LDKT)1. Patients who receive kidney transplants live 5-15 years longer than if
they remained on dialysis, and have a better health-related quality of life (HRQOL),
including a greater likelihood of being in the workforce during their critical earning
years2. While LDKT is the medically optimal and most cost effective renal replacement therapy
(RRT) for patients with ESRD, LDKT rates have declined by 17% from 2004-2014. In 2014, in the
U.S., 17,106 patients received a transplant (5,536 LDKTs) while 8,021 patients also died or
became too ill to remain on the list, 70% of whom were racial/ethnic minorities. Of the 2,039
transplants performed in California in 2014, only 595 were from living donors (OPTN data as
of 12/11/2015).

Since kidneys often fail slowly over months or years, a patient's level of kidney function is
monitored over time as it decreases in nephrologists' offices nationwide. As recommended by a
recent American Society of Transplantation (AST) Consensus Conference, all patients in Stage
3 (Moderate CKD), Stage 4 (Severe CKD), or Stage 5 (End Stage CKD) should receive
comprehensive education about DDKT and LDKT, especially racial/ethnic minorities. Once
patients reach ESRD and begin dialysis, established CKD and Centers for Medicare and Medicaid
Services (CMS) guidelines recommend that dialysis patients be educated about their RRT
options, the medical risks involved, and the advantages to transplant so that they can make
informed RRT decisions4. Since transplants received within the first 6 months of beginning
dialysis result in the best health outcomes,5 one Healthy People 2020 goal is to, "Increase
the proportion of dialysis patients wait-listed and/or receiving a deceased donor kidney
transplant within one year of ESRD start (among patients under 70 years of age)."
Unfortunately, research has shown that many patients in CKD clinics are inconsistently
educated about LDKT, particularly patients who are socioeconomically disadvantaged or members
of racial/ethnic minority groups.

Without a nationally-coordinated healthcare system, it is extremely difficult to ensure that
kidney patients in Stages 3-5 who are served by different health practitioners and
organizations all learn about DDKT and LDKT and make informed treatment decisions. Providers
also report having limited time to educate about transplant outside of transplant centers and
inadequate educational materials. Thus, disseminating transplant education within a large
health care system, with its fully integrated care management program, diverse membership,
and ability to track a large patient population across the entire course of their kidney
disease, may be an opportune way to educate large numbers of diverse patients about the
opportunities for and risks and benefits of living kidney donation.

Kaiser Permanente Southern California (KPSC) is a large, integrated healthcare system
providing coverage and care to over 4 million members throughout Los Angeles, San Diego,Kern,
San Bernardino, Riverside, and Ventura Counties. KPSC provides coverage to nearly 65,000
patients with CKD stages 3-5. About 24% of these patients are Hispanic, 52% White, 15% Black,
and 9% Asian, similar to the broader CKD population in California.

First, this team will conduct extensive qualitative and quantitative formative research to
understand and compare the knowledge, informed decisionmaking and educational needs of these
diverse patient groups prior to intervention. Second, they will design a Spanish-language
version of ET@Home. Third, they will conduct a randomized controlled trial (RCT) of 1,200
Black, Hispanic, Asian, and White patients in CKD Stages 3-5 where patients will be
randomized to receive: (1) no additional education other than what is provided within KPSC
(standard-of-care); or (2) a video-guided, four-part ET@Home program delivered by mail and
supported through bimonthly postcards and texting over six months. The study aims and
hypotheses are as follows: Aim 1: Using qualitative methodology, to assess the LDKT
educational needs of CKD Stage 3-5 patients and their support networks by race/ethnicity and
primary language spoken.

Hypothesis 1: CKD Stage 3-5 patients and their support networks will have varying needs for
educational content about LDKT based on their race/ethnicity and primary language spoken.

Hypothesis 2: Providers will identify important patient needs for LDKT educational content
and opportunities for improvement within the KPSC transplant educational system.

Aim 2: Before intervention, to assess differences in knowledge and decision-making about the
opportunities for and risks and benefits of living kidney donation for 1200 CKD Stage 3-5
patients by race/ethnicity and primary language spoken.

Hypothesis: Patients earlier in the CKD continuum, patients who speak Spanish, and non- White
patients will have less knowledge about the opportunities for and risks and benefits of
living kidney donation and will be making less informed LDKT decisions.

Aim 3: Compared to KPSC education, to conduct a randomized controlled trial in English and
Spanish of ET@Home for CKD Stage 3-5 patients to assess its effectiveness to increase LDKT
knowledge and decision-making by race/ethnicity and primary language spoken.

Hypothesis 1: At the conclusion of the trial, CKD patients who receive ET@Home will have
greater transplant knowledge and be more likely to make an informed treatment decision than
patients receiving KPSC education alone.

Hypothesis 2: ET@Home will be more or equally effective for patients earlier in the CKD
continuum, patients who speak Spanish, and non-White patients than patients in these
subgroups receiving KPSC education alone.

Inclusion Criteria:

1. Participant must be at least 18 years of age.

2. Participant must self-identify as African American, White, Hispanic, or Asian.

3. Participant must currently be classified as having CKD 3, 4 or 5.

4. Participant must be able to speak and read in English or Spanish.

Exclusion Criteria:

1. Participant is not classified as having CKD 3,4, or 5.

2. Participant cannot speak or read in English or Spanish.