Your Path to Transplant: A Randomized Control Trial of A Tailored Computer Education Intervention for Living Donor Kidney Transplant



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:May 2014
End Date:December 2017

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Computer Tailored Education Program to Reduce Disparities in Living Donor Kidney Transplant

Because of the deceased donor organ shortage, more kidney patients are considering whether to
receive kidneys from family and friends, a process called living donor kidney transplantation
(LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they
are less likely to receive LDKTs. To address this disparity, this randomized controlled trial
will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can
be increased when they receive access to the Your Path to Transplant computerized Expert
System (YPT). This trial will also examine how other known patient, family, and healthcare
system barriers to LDKT impact YPT's effectiveness.

Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical
evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program
(UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to
one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant
evaluation, patients in the YPT condition will receive individually-tailored feedback
reports, coaching, and socioeconomic resource guidance associated with reducing barriers to
access to LDKT. Control patients will receive usual care transplant education provided by
UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and
self-efficacy will be assessed at four time points: prior to presenting at the transplant
center (baseline), during transplant evaluation (approximately 2 months post-baseline), and
4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will
be assessed 18-months post-baseline.

At the conclusion of the study, we will have developed an innovative and cost-effective YPT
Computerized Expert System that could be utilized to tailor LDKT discussion and education in
different medical settings based on the needs of individual patients of different races.

This longitudinal, parallel randomized control trial has two treatment conditions with equal
allocation, the YPT intervention and the standard of care transplant education as provided by
UCLAKPT. Patients in both groups will be assessed at four time points: 1) a phone survey at
baseline; 2) a phone survey at 4 months post-baseline; 3) a phone survey at 8 months
post-baseline; and 4) a medical records review at 4, 8 and 18 months post-baseline.
Additionally, patients in the YPT intervention group will receive individualized YPT
transplant education at various time points: 14 days post-baseline by phone, the in-person
transplant education (ITE) session, during the 4 month post-baseline survey, and during the 8
month post-baseline survey. The date of the ITE education session cannot be fixed because it
may occur at different points in each patient's transplant evaluation process.

As patient records are received via the transplant database, a data manager will determine
which are eligible for the study, then assign eligible patients a PIN that has been
pre-randomized to treatment group before uploading the record to the recruitment database.
Randomization will be completed by using a computer software program called TTMX
(Transtheoretical Model Expert). Knowledge of treatment assignment is required at and after
this stage so that the YPT expert system can be delivered to patients randomized to the
intervention condition. Patients will be randomized into one of two groups: usual care or
intervention group.

Usual Care Control Group-UCLA The control group for this trial consists of the usual care for
transplant education which, for this facility, begins when a referral is made. A physician,
patient medical group or dialysis center can make the referral. Once UCLAKPTP receives the
patient's information via a patient information form and their insurance has been verified,
the patient is called to schedule an Education Seminar and a one-on-one evaluation
appointment. Next, both UCLAKPTP mail out an "Appointment Letter" for the patient to complete
and bring with them to Evaluation Day. These packets include a UCLAKPTP Appointment Letter
and a Doctor's Information Worksheet. Patients are asked to fill out and bring the
Information Worksheet with them on their appointment day. The evaluation day is a full day of
group education, physician appointment, meetings with several coordinators of care and if
necessary completing several medical tests with blood and urine collection. During the two
hour group education a power point presentation is given that reviews different
transplantation options including living and deceased donors as well as high risk donors. The
social worker concludes the education by reviewing important insurance information with the
group. Next, the patients have a series of individual appointments with the transplant
physician (either a nephrologist or a surgeon), a social worker and the transplant
coordinator where they can ask questions and will receive additional information on
transplant. Psychosocial evaluations are completed by the social workers to identify any risk
factors or red flags which would contradict transplant as a treatment. This routine is
standard for all patients evaluated for transplant. Patients in this group will be surveyed
at baseline, 4 months and 8 months post baseline. These surveys will be conducted over the
phone and can last up to 50 minutes each.

YPT Intervention Group Patients in the intervention group with receive individualized YPT
transplant education at four time points. Their total participation is estimated to be 2.5
hours. Printed materials and videos will be sent to the patients after each time point.
Patients will also receive individualized feedback reports based on their stage of readiness
to pursue DDKT and LDKT. In addition to being tailored to the individual's stage of
readiness, these reports will address any concerns the patient has mentioned as well as
answers to knowledge questions the patient may have missed.

YPT intervention: baseline time point. We will first administer verbal consent form and
assess for ineligibility criteria. After consent has been given and eligibility determined,
we will conduct a baseline assessment of the patient's demographics, knowledge, decision
making, readiness, and self-efficacy for both DDKT and LDKT. Family support and living donor
availability will also be assessed for LDKT. This time point is estimated to last 40 minutes.
At the end of the survey the patient will be asked schedule a time to conduct the first
education session.The education session will occur at any time up to 14 days after the
baseline assessment and will last between 20-30 minutes. The coach will then discuss the
patient's readiness to pursue DDKT. This will be guided by the patient's stage of change.
Next, the coach addresses the benefits of DDKT and provides coaching for any concerns the
patient mentioned in the assessment. After this, the coach will discuss the patient's over
all confidence for pursuing DDKT and then provide itemized feedback for problems the patient
believes will prevent them from pursuing DDKT. The coach will then provide the same education
and coaching for LDKT. At the end of the education session the coach will inform the patient
that they will meet the patient on the day of their ITE.

The coach will then mail a folder containing the first set of educational materials which
includes factsheets, brochures and the patient's personalized, tailored feedback report.

YPT intervention: ITE time point. The ITE session will occur at the UCLAKPTP during the
patient's medical evaluation visits. It is expected to last 40 minutes. Patients will be
taken to a semi-private area in the transplant center at either facility and re-assess the
patient's readiness to pursue DDKT and LDKT as well as the perceived benefits and concerns.
The patient's confidence for pursuing both DDKT and LDKT will also be re-assessed. We will
provide feedback to the patient based on any changes in readiness, confidence, and perceived
benefits or concerns that may have occurred since the initial assessment. DDKT feedback will
occur directly after DDKT re-assessment and LDKT feedback will occur after LDKT
re-assessment. The patient will then be asked to watch a 10 minute video while we print off
the patient's personalized feedback report. Based on the patient's stage of change, one of
two videos will be shown: "Pursuing Donation" to those patients who are in the
pre-contemplation and contemplation phases and "Exploring Donation" will be for patients in
all of the other stages. At the end of the session we will give the patient a second folder
with educational materials, a DVD, and their personalized feedback report.

YPT intervention: 4 month and 8 month time point. We will contact the patient four months and
eight months after their baseline survey. Pre-survey reminder postcards will be sent one
month prior to the survey. It is estimated that each survey will last 45 minutes. These
interviews will be similar to the baseline survey given at the beginning of the trial.
However, we will not re-assess demographic information, comorbidities, or unmet needs. At
both time points, we will provide tailored feedback throughout the interview. This will occur
immediately after the re-assessment of potential barriers to pursuing transplant, knowledge,
and transplant decision making for both DDKT and LDKT. During the eight month interview, we
will ask the patient questions regarding the cultural competency of their medical providers,
their decision about which treatment to pursue, and their ability to have made an informed
decision as to whether or not pursue DDKT or LDKT. As with previous time points,
individualized feedback reports and tailored education will be sent to the patients following
the phone call.

YPT patients: 4, 8, and 18 month medical record review. Patients' medical records will be
reviewed at 4, 8 and 18 months after their baseline survey in order to determine whether they
had: 1) been waitlisted for transplant; 2) received a DDKT; 3) received an LDKT; 4) gone
inactive or been determined ineligible for transplant; 5) died.

Inclusion Criteria:

- Self-identify as Black, White, or Hispanic

- Must not have been deemed kidney transplant ineligible by UCLA Kidney and Pancreas
Transplant Program

- Cannot be listed at another transplant center

- Can read English

Exclusion Criteria:

- Does not self-identify as Black, White, or Hispanic

- Deemed ineligible to receive a kidney transplant by UCLA Kidney and Transplant Program

- Listed at another transplant center

- Cannot read English
We found this trial at
2
sites
Kingston, Rhode Island 02881
Phone: 401-874-5082
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Kingston, RI
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Los Angeles, California 90024
Principal Investigator: Amy D Waterman, PhD
Phone: 310-206-7243
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Los Angeles, CA
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