Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation

SPECIFIC AIMS Kidney transplantation (KT) is the optimal treatment for end-stage kidney
disease (ESKD). It reduces mortality, improves quality of life, and is less costly than
dialysis. Further, living donor KT (LDKT) is better than deceased donor KT (DDKT) because:
(a) patients who can identify a living donor will get a KT much more quickly than ones
awaiting DDKT and, (b) LDKT yields better outcomes than DDKT by improving cost effectiveness,
reducing morbidity, and increasing long-term survival. The KT evaluation process, which
occurs after patients have been referred for KT, is lengthy, time consuming, and burdensome
to the patient. It requires patients to complete numerous tests (e.g., blood work, cardiac
checks, pap smear, etc.) in order to be presented to the transplant team and accepted for KT.
Although some variation between centers exists, typically patients must complete testing on
their own, and ensure that their clinical providers forward results to the transplant team.
This requires significant oversight and follow-up by the patient with each clinical provider.

The investigators' previous and ongoing NIDDK-funded research indicates that cultural factors
(i.e., perceived discrimination in health care, religious objection to LDKT), KT knowledge,
and demographic characteristics (e.g., age, education, income) independently and
significantly predict time to complete KT evaluation. Similarly, the investigators' research
found that African Americans (AA) take significantly longer to complete the evaluation
process, and that the factors identified to predict longer time to complete evaluation are
significantly associated with race. Other research has shown significant disparities in ESKD
and its treatment for members of vulnerable groups (e.g., Hispanic/Latino, Native Americans,
low income), and that African Americans (AA) are a particularly vulnerable group. For
example, although ESKD in AA is four times greater than in whites (WH), AA are less than half
as likely to undergo KT. AA race is associated with: (a) a longer time to complete evaluation
for KT,19 (b) lower likelihood of getting a KT, (c) lower rates of pre-emptive listing for
KT, and, (d) lower rates of LDKT versus DDKT. Therefore, two of the best ways to reduce
disparities in KT may be to increase (a) the number of vulnerable group members who complete
KT evaluation and (b) the rate of LDKT. This study is a two-pronged approach to address these
two critical areas.

In December 2012 the investigators' transplant center implemented a one-day streamlined
evaluation process, which they dubbed Kidney Transplant Fast Track (KTFT), but it has not
been evaluated for efficacy or cost effectiveness. Thus, the investigators propose a
quasi-experiment to determine the efficacy and cost-effectiveness in vulnerable groups of the
KTFT compared to historical controls who were recruited for their previous NIDDK study. This
component of the study will allow the investigators to take advantage of a unique and unusual
natural experiment which occurred due to system-level clinical changes in the way patients
are evaluated for KT at their center. The investigators will test if KTFT yields faster
evaluation completion times, and ultimately higher KT rates. The second component of this
study is to conduct a randomized controlled trial (RCT) targeting KTFT patients with the
educational component of the TALK intervention to increase LDKT. The KT evaluation period
poses an excellent opportunity to encourage patients to pursue LDKT. However, if the
evaluation period is compressed via programs such as KTFT, it becomes critical to maximize
patients' ability to pursue LDKT. For both the quasi-experimental and RCT components of this
work, the investigators will target vulnerable populations because they are most at risk for
extended evaluation times and lower rates of LDKT and these are the two most critical factors
leading to disparities in KT. Specifically, the investigators intend to:

SA1: Test the efficacy and cost-effectiveness of a comprehensive, system-level fast-track KT
evaluation for vulnerable groups in reducing time to complete KT evaluation, and increasing
KT rates.

H1a: Compared to historical controls, evaluation time will be reduced with KTFT evaluation.

H1b: Compared to historical controls, KTFT will increase KT rates. H1c: KTFT will be a
cost-effective evaluation strategy relative to standard evaluation practices.

SA2: Using an RCT, test the effectiveness of the TALK intervention in increasing rates of
LDKT during KTFT.

H2a: Compared to the no-TALK controls, rates of LDKT will be higher in the TALK group.

H2b: Participants in KTFT+TALK will have higher KT rates than historical controls and no-TALK
controls.

H2c: The addition of KTFT+TALK will be a cost-effective strategy to increase LDKT rates.

SA3: Determine whether engaging in a comprehensive, streamlined, and coordinated-care
evaluation experience within the transplant center reduces negative perceptions of the
healthcare system.

H3a: After KTFT, participants will report lower levels of medical mistrust than before KTFT,
and lower than historical controls.

H3b: After KTFT, AA participants will report lower levels of perceived discrimination and
racism than before KTFT, and lower than historical controls.

RESEARCH STRATEGY

SIGNIFICANCE The incidence and prevalence of end-stage kidney disease (ESKD) cases in the US
nearly doubled in the 1990s. In the US population, more than 590,000 adults are currently
treated for ESKD, and another 7.4 million have chronic kidney disease, which typically
advances to ESKD. The aging of baby boomers, changing racial distributions, and increasing
prevalence of diabetes in the US indicates that the prevalence of ESKD will continue to rise.
In 2010, the US spent more than $27 billion in Medicare funds to treat patients with ESKD.
Medicare costs per person per year range from $32,914 for KT patients, to $66,751 on
peritoneal dialysis, to $87,561 for hemodialysis. This amount does not include the money paid
by private health insurers as well as other sources of public health coverage such as the VA
and state funds or Medicaid. Although about 90% of that cost goes toward dialysis treatment
as the most popular modality for ESKD treatment, kidney transplantation (KT) is the optimal
treatment for end-stage kidney disease (ESKD). It reduces mortality, improves quality of
life, and is less costly than dialysis. Patients who can get a KT before starting dialysis,
fare better post-transplant than those who are transplanted after they have started dialysis.
Further, living donor KT (LDKT) is better than deceased donor KT (DDKT) because: (a) patients
who can identify a living donor (LD) will get a KT much more quickly than ones awaiting
DDKT7, and, (b) LDKT yields better outcomes than DDKT by improving cost effectiveness,
reducing morbidity, and increasing long-term survival.

Research has shown significant disparities in ESKD for members of vulnerable groups (e.g.,
Hispanic/Latino, Native Americans, low income), and that African Americans (AA) are a
particularly vulnerable group. The AA population is disproportionately represented among
patients with ESKD. Although AAs represent only 13% of the US population, they represent over
30% of those with ESKD. Since the late 1970s the incidence of ESKD increased at a fourfold
rate among AA compared with whites (WH). Kidney disease is particularly problematic because
its major causes are diabetes and hypertension, two diseases that are more prevalent among AA
and are related to a combination of physiological, lifestyle, behavioral, socioeconomic, and
healthcare access differences between AA and WH. AA race is associated with: (a) lower
likelihood of referral for KT among dialysis patients, (b) a longer time to complete
evaluation for KT, (c) lower likelihood of getting a KT, (d) lower rates of pre-emptive
listing for KT and, (e) lower rates of LDKT versus DDKT. Therefore, two of the best ways to
reduce disparities in KT may be to increase (a) the number of vulnerable group members who
complete KT evaluation and (b) the rate of LDKT. Our study is a two-pronged approach to
address these two critical areas leading to disparities.

Inclusion Criteria:

- Patients who have scheduled a kidney transplant evaluation appointment at the Starzl
Transplant Institute at the University of Pittsburgh Medical Center.

- Male or female

- English speaking

- ESKD patients aged 18 and over

- Patient has not previously received a kidney transplant

- Patient has not been accepted for kidney transplant in another center

Exclusion Criteria:

- Prior kidney transplant (excluded to eliminate the possibility that past experiences
would affect their current treatment decisions)

- Patient is already on the United Network for Organ Sharing (UNOS) waiting list through
another center

- Children under age 18 will be excluded because they have dissimilar underlying
conditions, response patterns and decision-making authority as a result of their
developmental stage and dependency on adult guardians.