Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
Phase: NA
Conditions: Chronic Kidney Disease, End-Stage Renal Disease
Sponsor: St. Barnabas Medical Center

 
Increasing Kidney Transplant Among Blacks on the Transplant Waiting List 
Trial registration: ClinicalTrials.gov Identifier: NCT02319447 
Date: December 22, 2019 
 
 
 
 

 
Background 
Compared to chronic dialysis, living donor kidney transplant (LDKT) and deceased donor 
kidney transplant (DDKT) both offer decreased mortality, increased quality of life, and lower per 
person per year costs1-4.  LDKT, however, offers several potential advantages over DDKT.  
LDKT is associated with better patient and allograft outcomes5, allows the transplant candidate 
to bypass the long waiting list for a DDKT, and minimizes (or eliminates) time spent on chronic 
dialysis.  Therefore, for most end-stage renal disease (ESRD) patients, LDKT is the best 
treatment option for their kidney failure. 
Unfortunately, Blacks are much less likely than non-Blacks to receive LDKTs6-9.  At the 
start of 2018, Blacks comprised 32.6% of the DDKT waiting list10.  During 2018, based on OPTN 
data, Blacks received 32.4% of DDKTs but just 12.2% of LDKTs.  Furthermore, for each year 
since 2000, the percentage of Black LDKT recipients has remained less than 15%.  
Unfortunately, every transplant center in the U.S. (out of 275) performs proportionally fewer 
LDKTs among Blacks than non-Blacks8.   
Past interventions have sought to help kidney transplant candidates, especially those 
who are Black, to identify living donors.  Health educators and other staff have intervened using 
videos, written materials, and in-person discussions to target patients who are not yet on 
dialysis11,12, patients on dialysis13-15, patients at their initial transplant evaluation16,17, and 
patients on the DDKT waiting list18. Some interventions have targeted chronic kidney disease 
(CKD) patients early in the transplant process, before they appear for transplant evaluation13,19.  
However, these “proximal” interventions may have difficulty in resulting in significant increases 
in LDKTs, especially given the short follow-up periods in most prospective studies13,14,19.  Other 
interventions have targeted CKD patients at transplant centers that usually perform few LDKTs 
in Blacks, often making these studies underpowered to demonstrate an increase in LDKT 
among Blacks16,18,20,21.  The only intervention that has been shown to increase LDKT or proxies 

 
for LDKT is home visits, but home visits have not been widely adopted due to their cost and 
difficulties in implementing them18.  Overall, almost all interventions designed to increase LDKT 
have been ineffective22.  
Patients with CKD have reported several barriers that may decrease the likelihood of 
receiving a LDKT23-27.  These barriers include: lack of knowledge about LDKT23,26,28,29, concerns 
about the donor’s future health23-26,29-34, guilt and concerns about inconveniencing the living 
donor23,25,26, difficulty in asking living donors and not knowing how to ask23,25,26,30,35,36, lack of 
medical trust37-43, and lack of interaction with recipients of successful LDKTs44-46.  Social, 
behavioral, and educational interventions to increase LDKT, especially among Blacks, would 
ideally address some or all of these barriers.   
Here, we describe the protocol of a randomized controlled trial that is testing the 
effectiveness of a multi-component educational program called “Destination Transplant”. 
Destination Transplant was designed to address some of these barriers to LDKT and increase 
receipt of LDKTs among Blacks or African-Americans. Our aims are to: 1) examine whether the 
educational intervention leads to an increase in Blacks’ readiness to pursue LDKT, and 2) 
examine the impact of the intervention on receipt of LDKTs among Black patients.  
 
Methods/Design 
 
Study Overview 
We designed a randomized clinical trial that will test the effectiveness of an educational 
intervention, Destination Transplant, at increasing, among Black transplant candidates, both 
readiness to pursue LDKT and actual receipt of LDKT.  The investigators will randomly assign 
kidney transplant candidates on the kidney transplant waiting list to either: (1) a control group 
that will receive Usual Care, or (2) an Intervention group that will receive a group-based 
intervention, as well as monthly mailings and a follow-up phone call by a transplant educator. 

 
Prior to initiation of intervention activities, Destination Transplant was registered on 
clinicaltrials.gov (Protocol # NCT02319447).  This study was approved by the human subjects 
Institutional Review Boards at Saint Barnabas Medical Center (SBMC) (12-69) and Rutgers 
University (Pro20150001749). 
 
Study population, inclusion/exclusion criteria, and randomization 
Study population 
The target population for this trial will be all kidney transplant candidates who are Black 
and placed on the active waiting list for a DDKT at SBMC.  Whenever possible, at the initial 
transplant evaluation at SBMC or one of our satellite locations, we will “pre-consent” and explain 
the trial to potential transplant candidates who are Black and being evaluated for transplant.  We 
will include potential transplant candidates who: ●identify themselves as Black; ●are ≥21 years 
of age; and ●give informed consent.  We will exclude potential transplant candidates who ●have 
limited English proficiency or ●are unable (e.g. cognitive impairment) or unwilling to give 
informed consent. An overview of the study design can be found in Figure 1 below. 
For the actual clinical trial, our inclusion and exclusion criteria are identical to the criteria 
for the Pre-consented group, with some additions.  In the actual trial, we will include kidney 
transplant candidates who ●are placed on the DDKT waiting list; ●identify themselves as Black; 
●are ≥21 years of age; and ●complete the baseline questionnaire; and exclude kidney 
transplant candidates who ●have limited English proficiency; ●are unable (e.g. cognitive 
impairment) or unwilling to give informed consent; ●lack a working telephone; ●live >150 miles 
from the transplant center; or ●were enrolled in our prior trial of an educational intervention at 
the time of the initial transplant evaluation17.  
 
Randomization 

 
Patients who are eligible and consented to the study will be randomly assigned, after 
completing the baseline measurement, to either Usual Care or the Intervention, in a 1:1 
allocation ratio.  Randomization will occur in blocks of 8, using random numbers.  
Randomization will be stratified by whether the study participant is newly placed on the waiting 
list (defined as placement on the waiting list <6 months prior to enrollment) or has already been 
on the waiting list (defined as placement on the waiting list ≥6 months prior to enrollment). 
Random number sequences will be generated by the off-site study biostatistician (P.O-S.).  To 
promote allocation concealment, the biostatistician will allocate study participants to their study 
arm at the time of randomization and inform the study coordinator of the assigned study arm.  
The study coordinator will contact potentially eligible transplant candidates by telephone to 
inform them of their assignment.  Study participants and the study coordinator will be aware of 
allocation to Usual Care or the Intervention group, but outcomes assessors will be blinded to the 
allocation group. 
 
Study aims & objectives 
The primary aim will compare LDKT readiness and LDKT receipt in the Intervention vs. 
Usual Care groups of our randomized clinical trial.  Our primary outcome is change in readiness 
to pursue LDKT, and our main secondary outcome is actual receipt of LDKT after 18 months of 
follow-up.  Other secondary aims will determine (a) the social and behavioral variables that 
modify the effect of the Intervention upon LDKT readiness and receipt; and (b) whether the 
intervention affects other precursors of LDKT readiness and receipt, such as knowledge about 
LDKT, self-efficacy, and other social and behavioral factors.    
 
Data collection, follow-up and outcomes 
Baseline Measurements 

 
After active placement on the waiting list, we will obtain “baseline” measurements of multiple 
social and behavioral attributes, via telephone questionnaires of all patients enrolled in the study 
(see Figure for flow of patients through the study).  If we are unable to administer the baseline 
questionnaires within 2 months of enrollment into the trial (e.g. within 2 months of placement on 
the waiting list for newly listed patients, or within 2 months of consent for the patients already on 
the DDKT waiting list), then we will not randomize the patient.  This requirement is intended to 
minimize later study dropout.  Study participants will be mailed a $25 gift card for this baseline 
measurement. 
 
Follow-up Measurements: Timing 
Each Usual Care study participant will be matched to one Intervention participant.  For patients 
randomized to the Intervention, we will administer a follow-up questionnaire by telephone, 
approximately 1 week after the Intervention.  At the same time, we will contact the matched 
Usual Care patient to administer the follow-up questionnaire.  This procedure will ensure that 
the post-Intervention follow-up questionnaires are administered at approximately the same time, 
post-listing, for both Usual Care and Intervention patients, and using the same modality 
(telephone).  A final administration of the study questionnaires will occur at 9 months after 
randomization for patients in both arms.  We will provide $25 gift cards for each of these two 
follow-up measurements. 
 
Standard of Care Components (Usual Care/Control Group) 
Participants who are randomized to receive the Usual Care engage in the standard education 
and evaluation process given to all patients at SBMC. While on the waiting list, transplant 
candidates are asked to inform the transplant center of important changes in their medical 
condition (e.g. hospitalizations) but otherwise typically have infrequent contact with the 
transplant center. Candidates return to the transplant center for periodic reevaluations by 

 
transplant staff, usually every 1-2 years, depending upon the transplant candidate’s medical 
comorbidities.  At these reevaluations, transplant personnel usually discuss LDKT.  These Usual 
Care patients will receive usual concomitant care but no additional formal education. 
 
Intervention Components (“Destination Transplant”) 
Destination Transplant was developed by a transplant nephrologist, a social psychologist, a 
health communication researcher, and a graphic designer.  Based upon the Transtheoretical 
Model (TTM) of Change47, Destination Transplant is designed to increase both readiness to 
pursue LDKT and actual receipt of LDKTs among Black transplant candidates. 
 
Destination Transplant Education Seminar 
The intervention will include a single, 60-90 minute educational and motivational 
seminar, delivered to small groups of Black kidney transplant candidates and their family and 
friends (see Table 1 for details). The Intervention seminar will feature a slide presentation that 
includes brief talks from a physician, patient educator and patient ambassadors (donors and 
recipients). We anticipate that each seminar will include 3-5 listed transplant candidates, as well 
as family and friends. These seminars will be held at one of our two sites—Saint Barnabas 
Medical Center (SBMC), our main site, or our satellite location at Newark Beth Israel Medical 
Center. At the end of each Intervention seminar, we will measure the patients’ perceptions of 
the cultural competence of the researcher and speakers. Additionally, at various different time 
points throughout the study period, patients will be given educational materials that were 
developed specifically for the Destination Transplant program. These education materials were 
modified based on early versions of stage-based, transplant education materials developed by 
the co-investigator (A.D.W) for her Explore Transplant and Your Path to Transplant educational 
programs.  

 
We developed a slide presentation as the main method of education delivery. This 
interactive presentation provides patients with the opportunity to learn general information about 
CKD, the waiting list, and different types of kidney transplant.  Facts about kidney disease, the 
waiting list, and transplant will be presented in a question and answer format in the slide 
presentation.  Patients will be asked to respond to true/false and multiple-choice questions and 
receive nearly immediate feedback from the research team and the physician.  The presentation 
focuses upon five types of kidney transplants that the transplant candidates can consider: 
1) DDKT from a “standard” donor 
2) “Nonstandard” DDKT (from donors with either a high kidney donor profile index (KDPI) 
or considered Public Health Service (PHS) increased risk) 
3) Multiple Listing at two or more transplant centers (DDKT at another transplant center in a 
different donation service area) 
4) Direct LDKT  
5) LDKT via Kidney Paired Donation (KPD) 
The slide presentation education is designed to progress through the treatment options 
from least to more difficult, in terms of additional effort needed on the part of the patient.  For 
instance, the first treatment option, DDKT from a standard donor, requires no additional action, 
given that each patient is already active on the DDKT waitlist.  Each of the five transplant 
options will be discussed in detail, with concluding statements outlining the necessary steps for 
selecting each option.  
Topics will include: 
 
Basic facts about CKD, transplant, and the waiting list.  This portion of the 
presentation is designed to increase participant knowledge of CKD, LDKT, and living 
donation.  Specific topics of this lecture include: ●basic facts about CKD, ●the 
kidneys, and dialysis; ●benefits of transplant; ●the DDKT waiting list and how it 

 
works; ●types of DDKTs, including high KDPI kidneys; ●and how to stay healthy and 
ready for a transplant.  
 
The experience of receiving a transplant (by a Black recipient of a LDKT).  A 
recipient of a LDKT who is Black will speak about their own experiences.  The exact 
content of the talk will vary according to the patient, but each talk will discuss the 
following:  ●personal background; ●how the patient developed CKD; ●experience 
while on dialysis or with CKD; ●how they recruited a living donor; ●the transplant 
surgery and early post-transplant experience; ●current life with a transplant 
(advantages and disadvantages); ●how their living kidney donor is faring after 
donation; ●misconceptions about kidney transplant; and ●audience questions. 
 
The experience of serving as a living kidney donor (by a Black living kidney donor).  
A living kidney donor who is Black will speak about their own experiences.  The 
exact content will vary according to the donor, but each talk will discuss the following:  
●personal background; ●how the donor became aware of the need for transplant by 
a loved one; ●why the speaker decided to become a live donor; ●testing and 
evaluations to become a donor; ●the actual donation operation; ●life after donation; 
and ●audience questions. 
 
Ways to more quickly receive a transplant.  In addition to encouraging LDKT, we will 
encourage study participants in the Intervention arm to consider the following ways 
to more quickly receive a DDKT: ●accept a high KDPI kidney, if deemed medically 
appropriate; ●accept a PHS increased risk kidney; ●get on the DDKT waiting list at 
other transplant centers outside New Jersey and the SBMC donation service area. 
 
Destination Transplant Education Folder 
As a supplement to the slide presentation, patients will be given a folder to take home 
that contains factsheets that provide an overview of the five types of kidney transplant. Although 

 
the content varies between the factsheets, all factsheets provide patients with instructions or 
further directions on what to do if they are interested in pursuing a particular option.  
 
Destination Transplant Postcards 
During the 9-month intervention period, patients will be sent one educational postcard 
per month that serves to provide both basic information about kidney disease and additional 
information about the five treatment options. These colorful postcards feature real recipients and 
donors and tackle tough topics including asking someone to get tested as a donor.  The 9 
postcards address the following topics:  
 
 “Your Exploration of Kidney Transplant Continues at Home”.  Welcomes patients and 
provides a short list of recommendations for patients who are waiting for a transplant 
 
“Consider All Types of Kidneys for Transplant”.  Encourages patients to consider 
nonstandard deceased donor transplant through use of High KDPI donor kidneys 
 
“Consider All Types of Kidneys for Transplant”.  Encourages patients to consider 
nonstandard deceased donor transplant through use of Public Health Service Increased 
Risk donor kidneys 
 
“Learn About Living Donation”.  Encourages patients to reach out to others for support 
and to consider living donor transplant as a treatment option  
 
“Learn Why People Want to Be Living Donors”.  Presents reasons why living donors may 
offer to help out a friend or a loved one. 
 
“Compare the Risks and Benefits of Living Donation”.  Provides information about the 
risks (including costs, future impact on health, and risk of death) associated with 
donating a kidney 
 
“Consider Getting a Transplant from a Living Donor”.  Provides a list of strategies that 
may be used to help an individual identify a potential donor 

 
 
“You Can Get a Transplant Even if Your Donor is Not a Match for You”.  Defines and 
explains how Kidney Paired Donation works 
 
“Weigh the Pros and Cons of All Your Options”.  Provides a side by side comparison of 
the pros and cons of dialysis, deceased donor transplant and living donor transplant 
 
3 Months post-baseline follow-up coaching call  
Approximately 3 months after the baseline assessment, patients in the intervention 
condition will receive a follow-up phone call from a coach (transplant research associate) to 
discuss topics including but not limited to: 
(1) their transplant plan and decision-making  
(2) what supports they have and/or need to ensure they are able to follow through 
with their transplant plan 
(3) how to discuss LDKT with friends and loved ones 
The purpose of the call is to provide additional education and support for patients. These 
conversations also provide additional opportunity for patients to discuss their feelings about and 
willingness to pursue the various transplant options. This call serves as a mini-assessment 
wherein the coach assesses patient readiness to pursue LDKT. At the conclusion of the 
coaching call, patients are given the option to receive additional educational materials designed 
to help bolster their confidence in potential discussions about their need for an LDKT. 
Patients expressing interest in learning more will be given the option to receive the 
Explore Living Donation Packet and the Finding a Living Donor Booklet.  Each resource 
provides patients with practical, skills-based information to help initiate conversations about 
living donation. Through these materials patients will engage with videos and print materials that 
provide detailed descriptions about how others have found living donors. Additionally, patients 

 
are given several sample letters that others have used with family and friends to help them 
identify potential donors.  
 
Evaluation and Statistical Plan 
 
Measures 
 
 
Patient information was obtained, mainly via questionnaires, at baseline, interim follow-
up (as explained above in Follow-up Measurements: Timing), and 9 months (Table 2).  
Descriptions of these measures are below.  Unless otherwise indicated, all measures were 
assessed at baseline, follow-up, and 9 months. 
 
Demographic, clinical, and cultural factors (baseline only) 
During the baseline assessment, patients will be asked some basic demographic and cultural 
questions such as their age, biological sex, race, and ethnicity. Clinical information will be 
collected, including data such as patient dialysis status and comorbidities such as diabetes, 
hypertension, and polycystic kidney disease.  
 
Transplant derailers (baseline only) 
Transplant derailers can be described as individual factors that might be sources of delay, 
difficulty, or challenge to a patient pursuing transplant. These factors include education, job 
status, income, health insurance quality, neighborhood/environmental assessment, financial 
stability, access to transportation, and family obligations. 
 
Transplant knowledge & health literacy 

 
To assess heath literacy, the two-item subjective health literacy and numeracy measure was 
used48. Extent of previous transplant education and current transplant knowledge measures 
were adapted from previously developed measures.49  The knowledge and education measures 
were designed to assess the amount and quality of transplant knowledge participants had.  
 
Small steps to pursue LDKT 
Small steps include a list of actions that people may take related to getting a living donor 
transplant (e.g., talk to people you trust about whether to get a living donor transplant or ask 
potential donors to be tested).  
 
Measures of readiness for LDKT, based upon TTM 
We use previously validated scales49 to measure readiness to pursue LDKT and the pros and 
cons of living donation. The readiness measures assess how ready patients are to take actions 
to pursue LDKT, based upon the stages in the Trans-Theoretical Model of Change (e.g. “I am 
not considering taking actions in the next six months to pursue living donation” (Pre-
contemplation)).  We also measured readiness using the scales developed by  Rodrigue et al.21, 
which also measure readiness for LDKT but use slightly different wording (e.g. “I am not thinking 
about or considering live donor kidney transplantation” (Pre-contemplation) and “I have thought 
about live donor kidney transplantation and I am seriously considering the possibility” 
(Preparation)).  The pros and cons assessment asks participants to rate the importance of a 
series of statements about transplant to their decision to pursue LDKT( e.g., “I will feel guilty 
having someone donate to me” or “With a living donor transplant, I will be able to contribute to 
my family and friends sooner”).   
 
LDKT Decisional Balance and Self-efficacy 

 
Decisional Balance items will measure the perceived importance to patients of the possible 
positive and negative outcomes of LDKT.  Patients will be asked “How important is this 
statement to your decision about living donor transplant?” and then be asked to respond to 12 
positive and negative statements (e.g. “I will feel guilty having someone donate to me”, “I will be 
healthier because I spent less time on dialysis”).  Responses will be measured on a 5-point 
Likert-type scale (1 = "Not important" to 5 = "Extremely important"). To assess LDKT self-
efficacy, we will use 6 items adapted from prior studies exploring LDKT49.  Items will measure 
how confident participants are that they could continue their pursuit of LDKT even if they were 
faced with a various challenges (e.g. “You don’t know anyone who might be a living donor for 
you” or “You asked someone to donate and they turned you down”).  Responses to these items 
will also be on a 5-point Likert scale, (1=”Not at all confident” to 5=”Completely confident”). 
 
Family Support & Living Donor Availability-  
These questions measure the participants’ support networks. Questions include the number of 
available donors, quality of the potential donors as determined by their health status, number of 
donor offers and willingness to consider paired donation. Additionally, a brief assessment of 
Unmet Social Support Needs50,51 will be used that compares the amount of transplant-related 
support participants have received in comparison to how much they’ve needed.  
 
General Health Status 
The Centers for Disease Control HRQOL-452 will be used as a measure of general health 
status. This 4-item assessment asks participants to report on overall health status (i.e., physical, 
mental, and emotional health) in the last 30 days.  
 
Medical Mistrust 

 
Medical Mistrust will be measured using the 7-item The Medical Mistrust Index53.  This scale 
examines whether or not patients trust health organizations. 
 
Cultural Competence Assessment 
Participants will be asked to reflect on the cultural competence of the project staff based on in-
person and telephone interactions. Items examine participant perceptions of whether staff 
presented clear information, treated them fairly, and were respectful and were adapted from 
supplemental cultural competence items that were part of the Consumer Assessment of 
Healthcare Providers and Systems.54  
 
Decisional Conflict Scale (follow-up and 9 months only) 
This scale asks respondents to reflect on the information they received about their treatment 
options and reflect on the option they chose (e.g., I know the risks and side effects of each 
option and I have enough advice to make a choice).55  
 
18-Month Records Review 
We will conduct a review of participants’ medical records to assess transplant-related outcomes 
at 18 months post-randomization. These measures will include: 
 
Receipt of LDKT 
We will determine whether or not trial participants have received a LDKT in the United States 
during the 18 months after they were randomized.  This determination will be made by 
examining our electronic medical records for each study participant.  If the person received a 
LDKT within the U.S., then we will determine whether this LDKT occurred at SBMC or some 
other transplant center. 
 

 
Recruitment of donor volunteers 
Using electronic transplant medical records at SBMC, we will determine how many donor 
volunteers contacted the transplant center to donate to each study participant during the 18 
month follow-up period.  Persons are considered “donor volunteers” after they (1) contact the 
transplant program to request an information packet regarding live kidney donation, and (2) 
complete and return a Living Donor Referral Form (included in the packet) to SBMC. 
 
Nursing education of donor volunteers 
After returning the Donor Referral Form, donor volunteers must complete an in-person 
education session regarding live kidney donation. As the first step in the donor evaluation, 
appearance at the transplant center for this education is a sign of the “seriousness” of the donor 
volunteer’s intent to donate.  For each study participant, we will determine how many (if any) of 
their donor volunteers appeared for an in-person nursing education session. 
 
Status on the DDKT waiting list 
We will determine the status of study participants still on the waiting list after the 18 month 
follow-up period. Specifically, we will determine whether they are: ●active (Status 1), or 
●inactive (Status 7) on the waiting list.  Other patients will have been removed from the SBMC 
waiting list because they: ●died; ●became too sick to transplant; ●refused transplant; 
●transferred to another center; ●improved and no longer required transplant; ●received a 
DDKT; ●received a LDKT; or ●other.  We will determine these reasons, along with the date they 
occurred, by querying the medical records for each patient. 
 
Statistical analyses 
Our initial analysis will be descriptive.  Our main analysis will use standard intention-to-
treat principles.  First, we will describe participants’ baseline characteristics and compare 

 
summary statistics of the Usual Care and Intervention groups.  These summary statistics will 
include mean, standard deviation, median, and range for continuous variables, and counts and 
frequencies for categorical variables.  Two-sample t-tests, Wilcoxon rank-sum tests (for non-
parametric variables) and chi-squared tests will be used to test for differences between the 
Usual Care and Intervention groups, as appropriate. 
For our primary outcome (increase in readiness to pursue LDKT), we will compare, using 
chi-square testing, the proportion of participants in the Usual Care vs. Intervention arms who 
have advanced at least one stage in their readiness to pursue LDKT (between the time of 
placement on waiting list and the time of reassessment at 18 months).  For our main secondary 
outcome (receipt of LDKT), we will compare, using chi-square testing, the proportion of study 
participants in the Usual Care vs. Intervention arms who have received a LDKT.  Sensitivity 
analyses will assess the intervention effect, adjusting for clustering of response by seminar 
group (because failing to account for clustering can reduce power)56,57.   
To determine which baseline factors (e.g. age), if any, modify the effect of the 
Intervention on the primary and secondary outcomes, logistic regression will model the log-odds 
of the outcome as a function of the intervention, while controlling for these factors of interest.  
Tests for modification by these key factors will be based on Wald tests of interaction terms 
between the intervention indicator and baseline factors.  We will perform logistic regression58 
and model-building as we have in prior published analyses59-61. 
To test the effect of the intervention upon other precursors of LDKT readiness and 
receipt (e.g. knowledge about LDKT, self-efficacy, and other social and behavioral factors), we 
will use stratified chi-square tests for categorical variables and linear regression models for 
semi-continuous scales.  The chi-square tests and linear regression models will be stratified by 
accumulated time on the waitlist at randomization (≤6 months vs. >6 months).  We will examine 
effects adjusted and unadjusted for baseline value for each respective scale. 
 

 
Power and sample size calculations 
The proportion of Usual Care (control) patients who have increased readiness for LDKT 
could plausibly range from 0.10 to 0.40, while the proportion who receives a LDKT is expected 
to equal 0.14 (based on prior baseline data from our center).  Assuming there are 250 or 200 
(assuming 100% and 80% retention rates) participants in each group, powers for increases of 
0.10, 0.15, and 0.20 are presented in Table 3.  In most scenarios, we have >80% power to 
detect a clinically significant increase in LDKT readiness and receipt of LDKT.  We may be 
slightly underpowered only for very small increases in these two outcomes.  Clustering by 
seminar in the Intervention arm may slightly reduce our power56,57,62, but we should have 
sufficient power to detect an effect of the Intervention upon our LDKT readiness and receipt. 
 

 
Abbreviations 
CKD: Chronic kidney disease;  
DDKT: Deceased donor kidney transplant; 
ESRD: End-stage renal disease;  
KDPI: Kidney donor profile index;  
KPD: Kidney paired donation;  
LDKT: Living donor kidney transplant;  
OPTN: Organ Procurement and Transplantation Network;  
PHS: Public Health Service;  
SBMC: Saint Barnabas Medical Center;  
TTM: Transtheoretical Model of Behavioral Change;  

 
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Figures, tables, and additional files 
Figure.  Flow of study participants through the study 
 
 
 
 
 
Listed for 
DDKT 
Usual care 
Intervention 
Follow-up study 
instruments 
Random
-ization 
Intervention 
seminar 
“Baseline” study 
instruments 
Outcome, 
18 months 
after listing 
for DDKT 
Study 
instruments 
Consent to 
trial 

 
Table 1. Intervention seminar components 
Topic 
Speaker 
Basic facts about CKD, transplant, and the 
waiting list 
Transplant physician 
Experience of receiving a transplant and 
LDKT 
Black LDKT recipient 
Experience of serving as a live kidney donor Black live kidney donor 
Wrap-up talk 
Transplant physician 
 
 
 

 
Table 2.  Outcomes and measures 
 
 
Baseline 
(after listing) 
1 wk after 
Intervention 
9 months after 
baseline 
18 months 
after baseline 
OUTCOMES 
 
 
 
 
Primary: Readiness to pursue LDKT (Stage of Change)  
X 
X 
X 
 
Main Secondary: Receipt of a LDKT 
 
 
 
X 
Number of donor volunteers recruited & evaluated 
 
 
 
X 
Status on DDKT waiting list 
 
 
 
X 
Knowledge of LDKT 
X 
X 
X 
 
OTHER MEDIATORS AND CORRELATES 
 
 
 
 
Transplant derailers 
X 
 
 
 
Previous transplant education 
X 
 
 
 
Health literacy 
X 
 
 
 
Small steps taken to pursue LDKT 
X 
X 
X 
 
Self-efficacy regarding LDKT 
X 
X 
X 
 
Family and social support 
 
 
 
 
Availability of potential living donors 
X 
 
 
 
General health status 
X 
 
X 
 
Decisional conflict 
 
X 
X 
 
Medical mistrust 
X 
 
X 
 
Pros/cons 
X 
X 
X 
 
Sociodemographics 
X 
 
 
 
Medical and treatment characteristics (etiology of CKD, 
dialysis type if any, dialysis vintage, etc.) 
X 
 
 
 

 
Table 3.  Power calculations for Primary and Main Secondary outcomes 
Proportion among 
Controls 
Proportion among 
Intervention 
Power 
250 participants per 
arm 
200 participants per arm 
Increase in readiness of at least one stage 
0.10 
0.20 
0.85 
0.76 
0.10 
0.30 
>.99 
>.99 
0.25 
0.40 
0.94 
0.88 
0.25 
0.45 
>.99 
0.99 
0.40 
0.55 
0.91 
0.83 
0.40 
0.60 
0.99 
0.98 
Receipt of LDKT 
0.14 
0.24 
0.78 
0.68 
0.14 
0.29 
0.98 
0.95 
0.14 
0.34 
>.99 
>.99