Transplant Social Worker Support for Live Kidney Donation in African Americans
Phase: NA
Conditions: Kidney Disease
Sponsor: Duke University

Transplant Social Worker Support for Live Kidney Donation in African Americans
 Document Date: December 21, 2022
NCT02369354
Abstract 
Live donor kidney transplantation (LDKT) represents an optimal therapy for many patients. 
However, African Americans have been persistently and significantly less likely to receive LDKT 
when compared to Whites. The process of seeking and establishing a live donor for LDKT 
requires potential donors overcome several potential obstacles to LKDT. As a critical first step 
to seeking LDKT, patients must engage their physicians and their family members or friends 
(who provide support for patients’ health decisions and could also be potential donors) in 
discussions about LDKT to determine whether LDKT is a viable and/or desirable treatment 
option. LDKT discussions with physicians help patients and family members understand the 
risks and benefits of LDKT to both the potential recipient and any potential donors. Families’ 
LDKT discussions help them establish whether it is possible to identify willing and medically 
eligible live donors, and they help families discuss the potential psychological, physical, and 
financial strains of LDKT on patients and families. Once discussions have occurred, potential 
donors must confront logistical (e.g., childcare or travel to transplant centers) and financial (e.g., 
unpaid time away from work) challenges associated with LDKT. Studies have shown that even 
when African American patients desire LDKT, rates of LDKT discussions are suboptimal. 
Further, African American potential live kidney donors are less likely than their White 
counterparts to complete the donor evaluation process, and they may be more sensitive than 
Whites to logistical and financial barriers to LDKT. Innovative strategies to overcome 
interpersonal, logistical and financial barriers to LDKT are sorely needed for African Americans, 
particularly those who may be highly motivated to seek this therapy. Transplant social workers 
routinely perform psychosocial evaluations on potential LDKT recipients and donors and are 
well suited to support families’ navigation of LDKT discussions. Transplant social workers are 
also well versed in the financial aspects of LDKT (e.g., insurance coverage rules) and frequently 
provide financial guidance to potential LDKT recipients and donors. We propose to study 
innovative transplant social worker led interventions that will help African American potential 
LDKT recipients and their families overcome interpersonal, logistical and financial barriers to 
LDKT. We will randomly assign African Americans on the deceased kidney donor waiting list to 
receive their usual care on the transplant list or to one of two social worker led interventions—
one which helps patients and families discuss LDKT with each other and with patients’ 
physicians, and one which provides families with financial support to overcome logistical and 
financial barriers to LDKT. As a primary outcome, we will measure whether the interventions 
activate live kidney donation on African American potential recipients’ behalves. The proposed 
study leverages our multidisciplinary team’s substantial prior experience studying culturally 
sensitive interventions to overcome barriers to LDKT among African Americans. 
Primary Objectives 
We will study the effectiveness of highly innovative transplant social worker led interventions 
that intervene on key knowledge, interpersonal, logistical and financial barriers to live kidney 
donation for African Americans patients on the deceased donor kidney waiting list. 
Objectives and Hypothesis 
A. Transplant Social Worker Educational and Behavioral Intervention. In our previous
work, we developed the Talking About Live Kidney Donation Social Worker Intervention
(TALK SWI), a culturally sensitive educational and behavioral intervention to improve
consideration and pursuit of live donor kidney transplants among patients with chronic
kidney disease (CKD) and their families. TALK SWI is tailored to accommodate patients
with low reading (i.e., 4thgrade) and health literacy levels and helps patients and their

families overcome self-identified interpersonal barriers to discussing and pursuing live 
donor kidney transplants. TALK SWI educational materials were determined to be 
culturally sensitive based on our conduct of 8 focus groups of African American and non- 
African American patients with chronic kidney disease (with and without live donor 
kidney transplant experience) and their family members identifying their concerns about 
live donor kidney transplantation19.In a recently completed randomized controlled trial,
we found TALK SWI was effective in improving rates of consideration and pursuit of pre-
emptive live donor kidney transplantation among patients with stage 4 CKD not yet on 
dialysis.22We propose to study the effectiveness of the TALK SWI intervention to
activate live kidney donation among African Americans who have recently registered on 
the transplant waiting list. We hypothesize the TALK SWI will be a powerful catalyst to 
increase live kidney donation for these patients who have already overcome some 
barriers to live donor kidney transplantation (i.e., completed the transplant evaluation). 
B. Transplant Social Worker Financial Assistance Intervention. We hypothesize a
financial assistance intervention delivered by transplant social workers to help patients
and their potential donors overcome logistical and financial obstacles to live donor
kidney transplantation will be well-received by social workers, patients, and their
families.
If effective, our financial intervention will provide a rationale for potentially expanding
current National Live Donor Assistance Center (NLDAC) policies. In a separately funded
study, we are currently testing the effectiveness of a financial assistance intervention to
improve access to live donor kidney transplantation among patients with end stage renal
disease (ESRD) who are not yet on the transplant waiting list. We hypothesize that
patients who are on the waiting list and highly motivated to receive a kidney (who we
propose to study in this application) will view this intervention favorably. The current
study leverages our substantial previous work to develop and test these
interventions. Our proposed study is a distinct and novel extension of our
previous work in three ways: (1) Placing the TALK SWI and the Financial Assistance
Intervention in the transplant social work environment: Neither intervention has
previously been studied in the transplant center, although this is a place where social
workers are already routinely employed in clinical care. Social workers have all the skills
necessary to execute both interventions, making this proposal a natural extension of our
prior work. (2) Studying patients on the deceased donor transplant waiting list: We have
not previously employed either intervention among patients waiting for a deceased donor
kidney. Because these patients are highly motivated to receive kidneys, employing the
interventions among this population could prove highly effective. (3) Combining TALK
SWI with the Financial Assistance Intervention: We have not previously employed these
interventions simultaneously. Because the interventions address distinct key barriers to
African Americans’ receipt of live donor kidney transplantation, we hypothesize
combining them could have an additive effect in overcoming barriers to live donor kidney
transplantation. To enhance the perceived long-term relevance of our interventions to
African Americans, we will measure the cultural competence of the transplant social
worker interventions using established measures developed by the Agency for Health
Care Research and Quality35and tailor the interventions to enhance their cultural
competence based on our findings.
Background and Significance 
Promise of Live Donor Kidney Transplantation to Address Disparities in Access to 

Kidney Transplants for African Americans 
Ethnic/race disparities in the incidence and prevalence of end-stage renal disease (ESRD) are 
striking. Over the past 20 years, African Americans have consistently had ESRD incidence and 
prevalence rates four times greater than Whites after adjustment for age and gender.1Kidney
transplantation offers patients with ESRD several benefits, including improved survival and 
quality of life at less cost than that of dialysis care.2-6However African Americans have been
persistently less likely than Whites to receive kidney transplants.7Donation rates of African
Americans have remained disproportionately low relative to the need for transplants among 
African Americans when compared to donation rates of Whites for the past 10 
years.1,7Suboptimal availability of deceased donor kidneys contributes to African Americans’
longer waiting times on transplant waiting lists when compared to Whites.8Live donor kidney
transplantation (LDKT) represents a promising strategy to improve access to kidney transplants 
for African Americans. LDKT not only offers improved outcomes over deceased donor 
transplantation but may also have the benefits of bypassing certain barriers to deceased donor 
kidney transplantation, including immunological incompatibility and longer waiting times.9-12 
Barriers Faced by African Americans to the Pursuit of LDKT and Live Kidney Donation 
Despite technological improvements in LDKT (such as laparoscopic donor nephrectomy) and 
widely publicized successes of LDKT, African Americans with ESRD continue to trail behind 
Whites with respect to the receipt of LDKT.1,13,14 A variety of barriers may contribute to
persistently lower rates of LDKT among African Americans compared to Whites including (1) 
inadequate knowledge or awareness of LDKT as a treatment option; (2) interpersonal difficulties 
initiating and sustaining discussions with families and the health care team about LDKT; (3) 
difficulties identifying willing and medically eligible live kidney donors; and (4) logistical and 
financial barriers to live kidney donation. 
Inadequate knowledge or awareness of LDKT.  
Studies show that African Americans with progressing chronic kidney disease (CKD) often have 
poor knowledge of transplantation as a treatment option when compared to their White 
counterparts.15Further, African Americans with ESRD often initiate dialysis therapy with little to
no prior discussion of transplantation with their health care providers, limiting their knowledge of 
LDKT.16Inadequate health literacy (defined as the ability to understand health information) has
also been linked to lower rates of transplantation17and may represent a barrier to receipt of
LDKT for African Americans. 
Interpersonal difficulties initiating and sustaining discussions about LDKT.  
African American patients often report they have difficulties initiating and sustaining discussions 
about LDKT with their families and health care providers8,11-14, which presents a major
roadblock to their active pursuit and ultimate receipt of LDKT. Even when African American 
patients on dialysis state that they desire LDKT, they have been shown to discuss LDKT only 
variably with their closest family members and their physicians.18Discussions about LDKT help
patients and families become informed about the risks and benefits of LDKT, explore the 
feasibility of identifying potential related donors, and take the steps necessary to complete 
donor and recipient medical evaluations in a timely manner. In studies, African American 
patients and their families have reported that their difficulties discussing LDKT stem from a 
variety of reasons, including their insufficient skill or discomfort with initiating discussions, their 
awkward feelings about discussing LDKT (e.g., concerns about coercing potential donors (for 

patients) or about openly expressing hesitance to be evaluated (for family members), and their 
desires for professional support to help them navigate complex family issues related to LKT 
(e.g., needs of children or financial considerations).19,20Initiating and sustaining discussions
may be particularly challenging to accomplish when many patients experience denial regarding 
their need to consider or discuss LDKT.19,21In our own recently completed study among
patients with progressing CKD but who had not yet started dialysis, an intervention designed to 
enhance patients’ and families’ pre-emptive discussion of LDKT was associated with patients’ 
greater pursuit of pre-emptive LDKT as a treatment option.22 
Difficulties identifying willing and medically eligible donors. 
Compared to Whites, African Americans may have pronounced difficulties identifying medically 
eligible and willing potential live kidney donors. African Americans in the general population are 
at greater risk than non-African Americans to experience diabetes and hypertension, the major 
risk factors for ESRD, which decrease their likelihood of being eligible to donate live kidneys.23-
25African American family members of patients with ESRD may have even greater future risk of
developing kidney disease when compared to those without a family history, adding further 
difficulty to identifying healthy related potential live kidney donors.26Because their likelihood for
identifying potential donors with risk factors for ESRD is so high, African American potential 
LDKT recipients may need to identify many willing potential live donors, to improve their 
chances of identifying one medically eligible potential donor. Nonetheless, studies show that 
even when African Americans have no obvious contraindications to donation, they are less likely 
to complete their medical donation evaluations when compared to Whites with the same 
potential health risks.27 
Logistical and financial barriers to LDKT.  
Live kidney donation poses several potential logistical and financial hurdles, such as 
travel/lodging expenses, lost wages from time off work, and expenses for domestic help among 
donors which may pose substantial barriers to live kidney donation among African 
Americans.28A recent study of the general public identified potential living donors who were
concerned about out of pocket expenses related to donation had 50% less odds of being willing 
to donate when compared to persons not concerned about expenses.29 In a separate study,
an overwhelming majority of the U.S. general public reported having favorable attitudes toward 
financial assistance programs which could help cover indirect costs for living donors, including 
costs associated with leave from work, with African Americans reporting significantly more 
favorable attitudes towards some forms of financial assistance when compared to Whites.30The
recently established National Live Donor Assistance Center, which provides financial 
subsistence to low income families represents the first national effort to address financial needs 
of the very poor (i.e., 300 percent of the Department of Health and Human Services (HHS) 
Poverty Guidelines) for whom these financial and logistical challenges pose barriers to their 
being evaluated for live kidney donation.31To date, however, the studies demonstrating the
effectiveness of this program or similar programs to enhance consideration or pursuit of live 
kidney donation among African Americans have not been published. 
Value of Transplant Social Worker Led Education and Support Interventions to Improve 
LDKT and Live Kidney Donation among African Americans on the Deceased Donor 
Kidney Waiting List 
Interventions providing African American patients and families with the support they need to 

overcome commonly encountered barriers to LDKT are critically needed. African American 
patients with ESRD who are waiting on the deceased donor kidney waiting list represent an 
excellent target population for such interventions, as they are highly motivated to receive 
transplants, have already overcome some barriers to receiving transplants (i.e., completed the 
transplant evaluation process), but may face barriers to identifying medically eligible and willing 
live kidney donors. Many transplant centers employ social workers to assess psychosocial 
needs of potential recipients and donors in the pursuit of LDKT.32Social workers are trained to
help potential recipients and donors address a broad variety of challenging health-related 
problems33,3 4and may be particularly well suited to help patients navigate commonly
encountered barriers to LDKT, including interpersonal barriers to initiating and sustaining LDKT 
discussions as well as identifying strategies (e.g., public or privately available programs 
providing financial assistance) to help them overcome logistical and financial challenges to 
LDKT. In our own previous work, patients with CKD and their families felt social workers could 
be particularly useful in helping them navigate often complex discussions about LDKT (including 
addressing issues such as potential donor coercion and discussing LDKT with children) as well 
as for helping them identify ways to overcome financial barriers to LDKT.19 To date, however,
effective interventions designed specifically to help social workers adequately address barriers 
to LDKT for African American potential recipients on the deceased donor kidney waiting list 
have not yet been established. Rigorously studied and effective transplant social worker led 
interventions could be employed widely across the US with confidence and could help to narrow 
ethnic/race disparities in access to kidney transplants. 
Design and Procedures 
Conceptual Framework 
We will refine and test the effectiveness of transplant social worker led educational, behavioral 
support, and financial assistance interventions to overcome barriers to receipt of LDKT among 
African American patients awaiting deceased donor kidneys and their families. Our conceptual 
framework draws from the PRECEDE-PROCEED behavioral model. In the model, Predisposing 
Factors (including knowledge, beliefs, attitudes, values, and motivations) are antecedents to 
behavior and provide the rationale for motivation for health behaviors of interest. Interventions 
designed to activate patients and families toward LDKT must address predisposing factors that 
pose barriers to pursuit of LDKT. 
Reinforcing Factors (such as social support, peer influence, significant others, and vicarious 
reinforcement) are factors that follow a behavior (e.g., potential recipient discussion and pursuit 
of LDKT) and provide continuing reward or incentive for the persistence or repetition of the 
behavior. For instance, interventions providing patients and their families with education and 
support for considering and pursuing LDKT may provide them with greater confidence to 
engage in behaviors leading to LDKT. Enabling Factors (such as programs, services, and 
resources necessary for persons to develop skills that enable health behavior changes) are 
antecedents to behavior that allow a motivation to be realized directly or indirectly through an 
environmental factor.59For instance, financial assistance interventions addressing their
logistical and financial concerns could propel family members to donate. Our study interventions 
will intervene on Predisposing Factors  which pose barriers to African American’s pursuit of 
LDKT, including patients’ and their families’ inadequate knowledge of LDKT, interpersonal 
difficulties initiating and sustaining family discussions about LDKT and LDKT discussions with 
health care providers, and logistical or financial barriers to LDKT. We will perform a randomized 

controlled trial to test the effectiveness of these transplant social worker led interventions as 
Reinforcing (through the effect of educational video and booklet providing basic education about 
LDKT and emphasizing the importance of engaging in discussion and pursuit of LDKT) and 
Enabling (by providing social worker support for family discussions about LDKT and by 
providing financial support to overcome logistical and financial barriers to live kidney donation). 
We hypothesize that the behavioral intervention will lead to patients’ and families’ greater 
pursuit of LDKT compared to usual care and the financial assistance intervention paired with the 
behavioral intervention will be most effective in increasing LDKT among African Americans on 
the kidney waiting list. Our primary outcomes will measure potential live kidney donors’ 
activation toward donating. 
Overview of General Approach 
We will study the incremental effectiveness of (1) an educational and behavioral social worker 
intervention and (2) a live donor financial assistance intervention to improve live donor activation 
and live kidney donation for African American patients on the deceased donor kidney transplant 
waiting list. The proposed mechanisms through which the interventions intervene on knowledge, 
interpersonal, financial, and logistical barriers to LDKT are listed in Table 1. In a two-phase 
study, we will first adapt the previously developed Talking About Live Kidney Donation (TALK) 
Social Worker protocol for use with transplant social workers (Phase 1), and we will then 
conduct a randomized controlled trial (Phase 2) to study the effectiveness of interventions to 
improve pursuit of LDKT (in recipients) and live kidney donation (among potential donors). 
Study Interventions 
1.
TALK Educational and Behavioral Social Worker Intervention (“TALK SWI”).The
Talking about Live Kidney Donation Social Worker Intervention (TALK SWI) is a culturally
sensitive theory-based intervention, which we previously rigorously developed in
collaboration with a behavioral psychologist, transplant nephrologists, transplant surgeons,
transplant social workers, patient advocacy experts from the National Kidney Foundation of
Maryland, and the input from patients and families with CKD and LDKT experience.39It
consists of an educational module (booklet and video) as well as a social worker led brief
behavioral support intervention to help patients and their families overcome barriers to
considering and pursuing LDKT. In a recently completed randomized controlled trial, the
TALK SWI was effective in activating patients to consider and pursue LDKT, including their
increased engagement in LDKT discussions, their completion of LDKT medical evaluations,
and their identification of potential live donors.22TALK SWI consists of (1) an educational
module and (2) a protocol-driven social worker behavioral support intervention. TALK SWI
directly addresses many concerns we previously identified among African American patients
and families considering LDKT.19
a.
TALK SWI Educational Module. The TALK SWI education module consists of an
educational 20-minute video and an educational booklet that are designed for
patients or their families to review alone or together. The video features minority
and non-minority patients who have undergone LDKT and their family members
discussing their experiences with considering LDKT as a treatment option from
the recipient and donor perspectives, as well as health care providers (transplant
surgeon, transplant nephrologist, transplant social worker) citing key factors
patients and families should consider when contemplating LKT.It also directly
addresses concerns that may pose specific barriers to LDKT for African
Americans, including mistrust or fear of the LDKT process, difficulties discussing
LDKT, and financial considerations related to pursuing LDKT. (The video can be
viewed at:http://ww w.youtube.com/watch?v=Wmo-

aTjZR64&feature=youtu.be) The educational booklet provides a synopsis of the 
LDKT process from recipient and donor perspectives. It also includes a listing of 
publicly available resources from which further information about the LDKT 
evaluation, transplant, and donation process, clinical risks with LDKT, and 
financial issues related to LDKT can be obtained. To assist patients and family 
members with initiating LDKT discussions or addressing complex issues during 
LDKT discussions (e.g., donor coercion), the booklet also presents several 
‘model conversations’ presenting examples on how to initiate and sustain LDKT 
discussions. (Booklet can be best viewed at: 
http://diseasemanagementboulware.org/wpcontent/themes/jhm/flipbook/tal
k- study/).
b.
TALK SWI Behavioral Support. TALK SWI Behavioral Support is a protocol-
driven individual and family- based social intervention applying a Social
Construction-based Family Problem Solving theoretical framework.44-
46According to this framework, families are problem solving units whose optimal
structure for confronting problems potentially affecting all group members, such
as ESRD and LDKT, is achieved when a neutral authority figure is designated as
the mediator for relaying messages between all members and encouraging open
channels of communication to enable each member to contribute to the
problem’s resolution, ultimately enhancing group satisfaction. The protocol
specifies that the TALK Social Worker will meet with patients considering LDKT
for up to one hour to assess their perceived barriers to completing key behaviors
reflecting their consideration and pursuit of LDKT (discussing LDKT with their
families, discussing LDKT with their physicians, identifying a potential live donor).
The TALK Social Worker employs motivational interviewing techniques to help
participants self-identify potential barriers they face toward completing LDKT
helps and patients strategize about ways they might overcome barriers. The
TALK Social Worker also invites patients to bring family members and/or friends
for a second visit. During family visits, the TALK Social Worker assesses the
extent to which previous family discussions about patients’ kidney disease had
occurred, the results of such conversations, whether family members have
communicated about LDKT with patients’ physicians, and any barriers family
members perceive toward achieving LDKT.39,47However, our focus groups
identified additional support roles that transplant social workers would be well
qualified to fill, including a role as a point of contact for patients and families
seeking financial assistance with LDKT.19During our Study Phase 1, we will
refine the TALK SWI behavioral support protocol to include these additional roles
that are routinely filled by social workers in transplant centers.
2. Live Donor Financial Assistance Intervention. We have designed a financial
assistance intervention to provide support for potential living kidney donors’ medical and
non-medical expenses associated with pursuing live kidney donation. The intervention is
modeled after existing federal live donor financial assistance programs (including the
National Live Donor Assistance Center (NLDAC) program), and it is intended to provide
financial support for potential live kidney donors in circumstances where existing federal
programs do not provide support. The intervention strictly adheres to US law governing
the reimbursement of expenses for potential live kidney donors. We will offer study
participants the option of enrolling their willing potential live kidney donors (i.e. persons
wishing to pursue medical evaluations to potential live kidney donors on their behalf)

reimbursement for medical and non-medical expenses related to the evaluation, surgery, 
and recovery periods associated with live kidney donation. Each study participant 
(potential kidney recipient) will be offered a “bank” of $2100.00 from which potential 
donors can receive reimbursement for live kidney donation related expenses. While 
multiple people may step forward to be evaluated for donation and incur expenses, the 
total amount available per patient study participant is $2100.00. Our intervention will 
provide reimbursement to a broad group of participants, of which many may not meet 
NLDAC income requirements. Participants not qualifying for NLDAC may not require the 
same level of financial reimbursement, or those choosing to forgo NLDAC may desire 
more broadly applicable financial assistance (e.g., for lost wages from work) than 
assistance provided by NLDAC. Based on national data, $2100.00 corresponds to 3 
weeks of paid leave from work for production or non-supervisory workers 48,
approximately 4 weeks of child care 49and travel and lodging needs for donors coming
from other geographic areas. If effective, our intervention will provide rationale for 
expanding current NLDAC qualification requirements. 
Features of our Live Donor Financial Assistance Intervention Compared to the 
National Living Donor Assistance Program (NLDAC)31
Feature 
Proposed 
Intervention 
NLDAC 
Financial Assistance Amount 
$2100 
$6000 
Potential Donor and Recipient Income Limits 
No 
300% 
poverty 
level or less 
Proof of Donor Financial Hardship Required 
No 
Yes 
Covers Travel, Hotel, Parking and Meal Costs Related 
to Donor Evaluation, Surgery, and Follow-up 
Yes 
Yes 
Covers Lost Wages from Work Related to Donor 
Evaluation, Surgery, and Follow-up 
Yes 
No 
Covers Child Care Related Costs Related to Donor 
Evaluation, Surgery, and Follow-up 
Yes 
No 
Adheres to NOTA 
Yes 
Yes 
Specific Intervention Details. We will reimburse potential donors for approved financial 
assistance through the study by submitting formal original invoices, receipts, and other 
documentation of their need for reimbursement of qualified medical and non-medical 
expenses related to live kidney donation evaluation, donation, or convalescence (up to 
10 weeks post LDKT procedures). Qualifying expenses include travel, doctor’s and 
hospital visits, lodging, meals, incidental expenses (e.g., parking, long distance calls), 
lost wages, and childcare costs incurred by the potential donor as part of (1) donor 
evaluation, clinic visit or hospitalization, (2) hospitalization for the living donor surgical 
procedure, and/or (3) medical or surgical follow-up clinic visit or hospitalization. All 
receipts must be submitted within 1 year (365 days) of the date the kidney patient 
(recipient) joined the study. Participants will be permitted to utilize the $2100.00 for 
multiple approved purposes, as long as the total value is not greater than $2100.00. 
Furthermore, more than one potential donor may draw from these funds, as the total 

value of reimbursed expenses does not exceed the value of $2100.00 per patient study 
participant. We developed the live donor financial assistance intervention following 
guidelines of the “Organ Donation and Recovery Improvement Act (ODRIA),” (Section 3, 
42 U.S.C. 274f) signed into law on April 5, 2004, establishing the authority and 
legislative parameters to provide reimbursement for travel and subsistence expenses 
incurred towards living organ donation. The intervention is also modeled after the 
National Living Donor Assistance Center (NLDAC), a federally funded program 
administered by the Division of Transplantation (DoT), Healthcare Systems Bureau 
(HSB), Health Resources and Services Administration (HRSA), United States Health 
and Human Services (HHS) through a cooperative agreement with the University of 
Michigan and the American Society of Transplant Surgeons 
(http://www.livingdonorassistance.org/default.aspx). We will advise all participants that it 
is possible that they may be disqualified from participating in other living donor 
assistance programs by participating in the TALKS Study program and they take 
personal responsibility to confirm their eligibility for other programs. 
Study Phase 1 (Planning Phase). Adaptation of TALK SWI for use in Transplant 
Centers 
Rationale. The TALK SWI was designed with input from African American and non-
African American patients and families with CKD to address common concerns about 
LDKT.19The TALK booklet and video were screened to ensure their appropriateness for
all persons considering LDKT, including minority and non-minority persons with low (i.e. 
4thgrade) reading level and low health literacy.39The TALK Social Worker Behavioral
Support Intervention was originally conducted by an independently practicing social 
worker affiliated with nephrology practices. The TALK SWI protocol was therefore 
tailored to be used by transplant social workers working in transplant centers. 
TALK SWI Adaptation Procedures. We reviewed the original TALK SWI protocol with 
transplant social workers and adapt the TALK SWI into their existing workflows. 
Adaptation focused on (1) ensuring the intervention provides adequately addresses 
patients’ communication and financial needs in social workers’ views, and (2) ensuring 
the intervention can be feasibly implemented and sustained by transplant centers long-
term. For instance, we asked social workers to identify the resources they typically 
provide to patients and families concerned about the financial aspects of LDKT and we 
incorporated provision of these materials into the protocol. We also identified potential 
challenges transplant social workers typically encounter with TALK SWI implementation. 
Study Phase 2 (Randomized Controlled Trial Phase) 
We will perform a randomized controlled trial to assess the effectiveness of TALK SWI 
and the TALK SWI plus financial support intervention to improve rates of LDKT among 
African American potential transplant recipients on the deceased donor kidney waiting 
list at the Duke Kidney and Pancreas Transplant Program compared to usual care. We 
will follow potential recipients for 1 year via questionnaire and 2 years via medical 
records (post baseline questionnaire completion) to assess live kidney donor activation 
on their behalves (live donor inquiries, completed new live donor evaluations, or live 
kidney donation) (primary outcome). We will assess all primary outcomes at 1 year after 
baseline enrollment. We will also assess potential recipients’ self-reported behaviors 
reflecting their pursuit of LDKT, including their conduct of LDKT discussions with 
physicians and with their families and their identification of potential live donors. 

A. Study population: We will recruit a total of 300 (100 per each study arm) adult African
American patients with ESRD who are currently on the deceased donor kidney
waiting list with no prior kidney transplant from the Duke Kidney and Pancreas
Transplant Program (DKPTP). The DKPTP cares for a highly diverse set of patients with
ESRD, with nearly 55% of the deceased donor kidney transplant waiting list comprised of
African Americans annually. As of January 2014, the DKPTP had 297 (55%) African
American patients registered on the deceased donor kidney waiting list. DKPTP added
approximately 100 new African American waiting list registrants per year in 2012 and
2013. African Americans on the deceased donor kidney waiting list at DKPTP are
sociodemographically diverse, and reflect the local Durham, NC population in which 19%
have incomes below the Federal Poverty Level.50
B. Study Setting: The kidney/pancreas transplant program at DKPTP is a highly innovative
center, providing national leadership in the development and implementation of
numerous clinical strategies to improve rates of live kidney donation and donor safety
(performed first kidney transplant in NC and had performed their 3000thkidney transplant
in 2010). The center also features a complete team of transplant surgeons, nurse
transplant coordinators, administrative transplant coordinators, psychologists, and social
workers to support both potential recipients’ and donors’ medical and psychosocial
needs. The program currently does not have a social worker program tailored specifically
to address knowledge, interpersonal, logistical or financial barriers to LDKT in African
American potential recipients.
C. Study Design: We will recruit, enroll and then randomly assign participants to one of
three study conditions (“arms”). We will follow participants actively for 1 year to assess
the effectiveness of interventions to improve live kidney donation and receipt of LDKT
among study participants.
Arm 1. Usual Care (N=100): Participants randomly assigned to this arm will receive their
usual care with the transplant team while awaiting a deceased donor kidney transplant.
Participants are periodically contacted (approximately once per year) to establish their
continued desire to be listed on the waiting list and to address any administrative issues
related to transplant (i.e., updated contact and insurance information) by the DKPTP.
They will be mailed the booklet and video at the end of the study.
Arm 2. TALK SWI (N=100): Participants randomly assigned to this arm will receive the
TALK SWI delivered by a transplant social worker.
Arm 3. TALK SWI Plus Financial Assistance (N=100): Participants randomly assigned
to receive the TALK SWI Plus the Financial Assistance for Living Donor Expenses will
receive the TALK SWI as described for Arm 2. Study staff will also provide participants
with information about the study Live Donor Financial Assistance Intervention, and
provide instructions on how to use the Intervention (details on Financial Assistance
Intervention described above)
D. Study Outcomes and Assessments: We perform assessments at baseline, 4 months and
12 months for all participants in Arms 1, 2 and 3. Transplant coordinators at DKPTP
routinely capture names and contact information of potential donors contacting the
center to inquire about donation procedures on potential recipients’ behalves and enter it
in the Phoenix (PHX) transplant application, which is part of the EpicCare Ambulatory

module. For our primary outcome, we will assess “live kidney donor activation”, defined 
as the composite rate of live kidney donor inquiries on behalf of participants (clinic 
records of individuals inquiring about the process of being considered for LDKT on 
participants’ behalves), completed live kidney donor transplant evaluations (recorded 
and tracked by transplant coordinators), and live kidney donor transplants (LDKT) in 
each arm after 12 months study enrollment. To determine which behaviors were most 
strongly activated by our interventions, we will also assess rates of these individual 
events in each arm in post-hoc analyses. Secondary outcomes will include 
measurement of behaviors reflecting patients’ and their families’ interest and pursuit of 
LDKT, including: self-reported LDKT discussions with physicians, self-reported LDKT 
discussions with family, and identification of a potential live donor. We will also assess 
several other correlates of participants’ willingness or ability to pursue LDKT, including 
their demographic characteristics, family function, self-efficacy with regard to decision-
making about LDKT, perceptions of trust in their health care team. We will ask all 
participants about their use of any financial assistance programs, including the types and 
amounts of expenditures reimbursed. We also will track expenditures reimbursed 
specifically by participants in Arm 3. We will also passively follow participants for one 
additional year through their medical records to determine if participants achieve 
outcomes of interest after 1 year. 
Assessment of Environment and Intervention Cultural Competency: We will measure the 
cultural competency of the DKPTP and transplant social workers using the Agency for 
Health Care Research and Quality CAHPS Cultural Competence Item Set35, designed
to capture patients’ perspectives on the cultural competence of health care providers. 
Items include information on (a) research subject-health care provider communication 
including shared decision-making; (b) experiences of discrimination due to race, 
ethnicity, insurance, or language; (c) experiences leading to trust or distrust; and 
linguistic competency. We will also add questions to ask specifically about the 
communication and shared decision-making skills of transplant social workers employing 
TALK SWI. 
Intervention Fidelity and Uptake: We will ask participants whether they have used the 
TALK Education Module and/or shared it with family members through telephone 
questionnaires administered at 4 and 12 months follow up. To assess social workers’ 
fidelity to the SWI protocol, we will audiotape and transcribe all TALK SWI meetings and 
assess the TALK social worker’s adherence to key behaviors specified in the protocol. 
We have previously assessed social workers’ adherence to the TALK social worker 
intervention in this manner and found the TALK SWI could be consistently 
executed.47For participants randomly assigned to the Financial Assistance Intervention,
we will assess via questionnaire whether participants made others (i.e., family members) 
aware of their participation in the Financial Assistance Intervention. We will also assess 
family members’ inquiries to use the Intervention and types and amounts of expenditures 
they reimburse. 
Selection of Subjects 
Patient Participants: Patients with end stage renal disease, who have completed the evaluation 
for kidney transplantation, are aged 18 and older, African American, and are on the deceased 
donor waiting list will be recruited from the DKPTP. We will work with DKPTP/Maestro Care 

(Duke’s electronic medical record) to identify eligible patients over a period of potentially two 
years, or until we reach our sample size. 
NOTE: We later expanded our inclusion criteria to include persons who have previously 
received a deceased donor kidney transplant but who have not previously received a live donor 
kidney transplant.  
Family/Friend Participants: Family/friend participants will only be enrolled for patient participants 
enrolled in Arms 2 and 3 if patient participants identify them. Once a patient participant is 
enrolled in the study and has completed their first TALK SWI meeting, they will be asked if they 
would like to identify at least one family member or friend to bring to the second TALK SWI 
meeting and be approached for participation in the study. 
Potential Live Kidney Donor Participants: Potential live kidney donors will only become aware of 
the Donor Financial Support Intervention through referrals by patient participants randomized to 
ARM 3 who voluntarily choose to make potential donors aware on their own accord, without 
prompting from study staff or the study Social Worker. Study staff and the study Social Worker 
will not contact or attempt to contact any family, friends, or acquaintances of enrolled patient 
participants. Patient participants in ARM 3 will be given a brochure (by study staff after the first 
TALK SWI meeting) for the donor financial support program and encouraged to share the 
information with people. 
We will advise patient participants to ask potential donors to contact us directly only for 
questions related to the financial program. The financial assistance program being offered as 
part of this study is intended to provide reimbursement only in those circumstances when 
payment cannot reasonably be covered by other sources of reimbursement. Under Federal law, 
reimbursement to any living organ donor for travel and other qualifying expenses may only be 
provided if the donor cannot receive reimbursement for these expenses from any of the 
following sources: 
1. any State compensation program, an insurance policy, or any Federal or State health
benefits program;
2. an entity that provides health services on a prepaid basis; or
3. the recipient of the organ.
All persons who wish to become living organ donors are eligible to receive reimbursement 
from this study for their travel and qualified expenses if they cannot receive 
reimbursement from the sources outlined above and if they meet all the requirements for 
donor reimbursement as outlined below: 
1. prove that they are either U.S. citizens or lawfully admitted residents of the U.S.;
2. have primary residence in the U.S. or its territories;
3. travel is originating from the donor’s primary residence;
4. donor and recipient attest to full compliance with section 301 of the National Organ
Transplant Act (NOTA), as amended (42 U.S.C. 274e) which stipulated in part “ * * * (i)t
shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any
human organ for valuable consideration for use in human transplantation if the transfer
affects interstate commerce. The preceding sentence does not apply with respect to
human organ paired donation”;
5. the transplant center where the donation procedure occurs attests to its status of good
standing with the Organ Procurement and Transplantation Network (i.e., it is not a

Member Not in Good Standing); and any individual who in good faith incurs qualifying 
expenses toward the intended donation of an organ but with respect to whom no 
donation of the organ occurs. 
Subject Recruitment and Compensation 
We will recruit three types of participants: (1) patients (“patient participants”) with ESRD, (2) 
their family members and friends (“family/friend participants”), and (3) their potential live donors 
(“live kidney donor participants”) for this study. Participants will be informed their participation 
will have no effect on patients’ or their own subsequent insurance or health care, including their 
access to a kidney transplant, and that none of their data will be given to their physicians so 
they could be personally identified. Participants will also be advised and they can refuse to 
participate in any aspect of the study at any time. 
A. Patient Participants
1. Screening, Recruitment, and Random Assignment
a) Potential patients will be identified through Maestro Care and the DKPTP PHX
reporting system for screening purposes and updates throughout the two year
recruitment period or until we reach our sample size. 
b) Study staff will review the list to ensure potential patient participants meet preliminary
study criteria (i.e., African American, age 18 or older, are on deceased kidney
transplant waiting list, no prior kidney transplant).
A letter from DKPTP, signed by all physicians and surgeons in the DKPTP will be 
mailed to potential participants and will be accompanied by a letter from Dr. 
Boulware describing the study and offering potential participants an opportunity to 
contact the research team with interest in participating or to opt-out from 
participation by either returning the provided form with a self-addressed mailed 
envelope, or by emailing or calling the telephone number provided prior to the first 
telephone call. A consent form will be included for them to sign and return, and 
additional one to keep for their records. (Note: A label with the unique TALKS Study 
ID will be placed on the back of the signature page to verify we have documented 
the return for the correct participant.) Risk and REALM questions will be included 
for them to refer to during the baseline questionnaire. 
c) Following the 14-day opt-out period, study staff will contact potential patient
participants, who have not opted out, via telephone to confirm eligibility, answer any
questions, review the consent form and obtain verbal consent. (If patients contact 
us prior to that, they are allowed to take part then.) Study staff will administer the 
baseline questionnaire. Potential patient participants will be asked to also sign and 
return the written consent form within the week. We will attempt to remind them to 
return their signed consent form at future contacts. 
d) Random assignment to intervention arms will take place immediately following
completion of the baseline questionnaire while patient participants are on the
telephone so they can be informed of their upcoming contacts. 
e) Study staff will mail the DVD and booklet to patient participants randomly assigned to
Arms 2 and 3, as well as the TALKS Financial Assistance Program pamphlet and
forms to Arm 3 only. 
f) Study staff will mail patient participants a thank you note and $30 check for
completing the baseline questionnaire.

Usual Care (Arm 1) 
h) Patient participants assigned to receive Usual Care (Arm 1) will receive their care at
DKPTP as they usually would.
TALK Social Worker Intervention (Arms 2 and 3 only) and Financial Intervention 
(Arm3 only) 
i) Patient participants randomly assigned to Arms 2 and 3 will be asked to review the
20-minute TALK video and booklet related to living kidney donation, as well as
attend two meetings with the study Social Worker to talk about LDKT. If the patient
participant says they are unable to attend an in-person meeting due to distance,
lack of transportation, or their health issues does not allow them to travel, we will
offer the Social Worker meeting (SWI) via telephone. This will not be offered to any
patient participant unless they mention the barriers noted above. We will offer this
prospectively to newly consented patient participants as well as for those who were
consented previously and were unable to take part in the SWI meeting due to these
same barriers, (recorded in our database), we will contact them via phone to offer
this option.
j) Study staff will schedule patient participants first meeting with the study Social Worker
following the baseline questionnaire and contact them a few days prior to remind 
them of the meeting and to encourage them to review the DVD and booklet. 
In-Person SWI: Study staff will also mail patient participants a reminder letter with 
the appointment date, time and directions. 
Telephone SWI: Study staff will ask if they want to provide a number to receive a 
text and/or an email address, or prefer a mailed letter with the appointment date, 
time and toll-free WebEx phone number and access code to call in to a social 
worker session with the study Social Worker. Study staff will also remind them of 
their appointment via phone/text/email a day or so prior. 
k) In-person SWI: On the day of their first meeting with the study Social Worker, study
staff will meet the patient participant 30 minutes prior to the meeting to review the
DVD and booklet. 
Telephone SWI: On the day of their first meeting, the Social Worker will call in to 
the toll-free WebEx number. If the patient participant does not join the call, study 
staff will contact the patient participant via phone/text to remind them of the call and 
reschedule if needed. If the patient participant joins the call, the Social Worker will 
verify they have reviewed the DVD and booklet. If they have not viewed the DVD, 
the Social Worker will encourage them to do so after the call and will proceed with 
the social worker session. 
l) The patient participant will then meet/talk with the study Social Worker for up to one
hour. We will audiotape the social worker sessions (In-person SWI: encrypted 
audio voice recorder; Telephone SWI: encrypted audio voice recorder using 
speakerphone in a GIM private office) as described in the initial consent. If they 
refuse, the sessions will continue and only handwritten notes will be taken by the 
study Social Worker. 
m) In-person SWI: Patient participants will be asked to attend a second visit with the
study Social Worker to further discuss their possible pursuit of LDKT. They will be
instructed they may bring adult family members and friends to the second session,
if they desire. We will schedule the second Social Worker session at a time that is
convenient for patient participants and any family members or friends they wish to
bring to the second session. Telephone SWI: Patient participants will be asked to
take part in a second telephone SWI session with the study Social Worker to further
discuss their possible pursuit of LDKT. They will be asked to invite adult family

members and friends they want to take part in the second session. Study staff will 
attempt to schedule the call at that time. They will ask the patient participant if they 
want to provide a number to receive a text and/or an email address, or prefer a 
mailed letter with the appointment date, time and toll-free WebEx phone number 
and access code to call in to a social worker session with the study Social Worker. 
They will be asked to share the call-in information with family/friends who may want 
to join the second SWI session. 
n) In-person SWI: Study staff will administer a brief 10-minute hardcopy questionnaire
to the patient participant immediately following the Social Worker session to obtain
feedback about the acceptability of the TALK SWI. We will provide assistance with 
reading the questions and checking the responses if needed. Telephone SWI: 
Once the SWI session is complete, the Social Worker will ask the patient participant 
to remain on the line to schedule their next session, complete their post assessment 
and paperwork for payment. The Social Worker will leave the call and immediately 
notify one of the other study staff to join the call and 
1) administer the brief 10-minute questionnaire 2) complete the paperwork required
for payment; and, 3) if in Arm 3, see item (o) below.
Financial Intervention (Arm 3 only) 
o) In-person SWI: Patient participants in ARM 3 will briefly meet with study staff
immediately following their first session with the study Social Worker. Study staff
will provide and review a brochure and materials for the donor financial support with 
patient participants. Patient participants will be encouraged to share the information 
with family members, friends and acquaintances if they desire, and to have 
potential donors contact study staff if interested. 
Telephone SWI: Patient participants in ARM 3 will briefly review and discuss the 
brochure and materials they received in the mail for the donor financial support with 
study staff during the first SWI call. Patient participants will be encouraged to share 
the information with family members, friends and acquaintances if they desire, and 
to have potential donors contact study staff if interested. Study staff will mail 
additional copies of the materials if needed.  
TALK Social Worker Intervention (Arms 2 and 3 only) 
p) Study staff will mail patient participants a thank you note and $50 check for
completing the first session with the study Social Worker.
q) In-person SWI: Study staff will mail patient participants a reminder letter with the
appointment date, time and directions. Study staff will contact patient participants
by telephone a few days prior to their second Social Worker session to remind them 
of their meeting and to invite any family members or friends they wish to bring to 
the second session. 
Telephone SWI: If the patient participant did not schedule the second social worker 
session, study staff will contact them to schedule a date and time. Study staff will 
ask the patient participant if they want to provide a number to receive a text and/or 
an email address, or prefer a mailed letter with the appointment date, time and toll-
free WebEx phone number and access code to call in to a social worker session 
with the study Social Worker. Study staff will email, text and/or mail patient 
participants a reminder letter with the appointment date, time and toll-free WebEx 
phone number and access code. Study staff will also remind them of their 
appointment via phone/text/email a day or so prior to the session. Study staff will 
remind them to share the call-in information with family/friends. 
r) In-person SWI: On the day of their second session with the study Social Worker,

study staff will meet with the patient participant and their consenting family 
member(s)/friend(s). Telephone SWI: On the day of their second session, Study 
Staff will call in to the WebEx toll-free line. If family/friends call in, the Study Staff 
will verify they are 18 or older, review the study and obtain verbal consent from 
each family/friend as well as request a contact number to call them back individually 
after the session to complete a brief 10-minute questionnaire via phone 
immediately following the social worker session; and, 2) complete the paperwork 
required for payment. If the patient participant does not join the call, study staff will 
contact the patient participant via phone/text to remind them of the call and 
reschedule if needed. The session cannot occur without the patient participant 
present even if family/friends have joined the call. No family/friends will be 
consented without the patient participant present on the call. Study staff will contact 
the patient participant to reschedule if they do not join the call. Once family/friends 
are consented, the study staff will leave the call and the Social Worker will join to 
begin the session.  
s) The patient participants and family/friend participant(s) will then meet/talk with the
study Social Worker for up to one hour. The session will be audio recorded (In-
person SWI: encrypted audio voice recorder; Telephone SWI: encrypted audio 
voice recorder using speakerphone in a GIM private office) as described in their 
consents, but if they refuse to be audio recorded, the session will continue and only 
handwritten notes will be taken by the study Social Worker. 
t) In-person SWI: Study staff will administer a brief 10-minute hardcopy questionnaire
to the patient participant immediately following the Social Worker session to obtain 
feedback about the acceptability of the TALK SWI. We will provide assistance with 
reading the questions and checking the responses if needed. Telephone SWI: 
Once the SWI session is complete, the Social Worker will ask the patient participant 
to remain on the line to complete their post assessment and paperwork for 
payment. They will remind the family/friends that Study Staff will contact them 
shortly to complete their post assessment and paperwork for payment. The Social 
Worker will leave the call and immediately notify one of the other study staff to join 
the call. The Study Staff will 1) administer the brief 10-minute questionnaire, and 2) 
complete the paperwork required for payment. If consented family/friends attended, 
the Study Staff will call the family/friends to 1) administer the brief 10-minute 
questionnaire, and 2) complete the paperwork required for payment.  
u) Study staff will mail patient participants a thank you note and $50 check for
completing the session with the family/friend participant(s) and study Social Worker. 
2. Assessments
v) All patient participants (regardless of their random assignment) will be contacted at 4
and 12 months to complete follow up questionnaires via telephone. Study staff will
mail a thank you note and $30 check for completion of each of the questionnaires. 
All questionnaires are approximately 60 minutes in length. 
w) All patient participants will be followed for 2 years (post baseline questionnaire
completion) via electronic medical records (i.e., MaestroCare and DKPTP PHX
reporting system) to passively assess live kidney donor activation on their behalves 
(live donor inquiries, completed new live donor evaluations, or live kidney donation) 
as well as their status on their wait list (active/inactive). 
B. Family/Friend Participants
Adult family members and friends are only eligible to participate in the TALK SWI session 

if they agree to participate after being invited by a patient participant. 
In-Person SWI: At patient participants’ request, they will attend the SWI session with the 
study Social Worker and patient participant and will be approached to assess their 
willingness to participate in the study by study staff when they arrive with the patient 
participant for the social worker session. 
Telephone SWI: Patient participants will share the call-in information with family/friends 
whom they want to join the session. They will be asked their willingness to participate in 
the study by study staff when they call in for the social worker session. 
1. Recruitment and Consent
a) In-Person SWI: When family/friends (up to 5 family members per patient participant)
attend the second social worker session with patient participants, study staff will
ask to meet with potential family/friend participants separately from patient 
participants, to verify they are 18 or older, review the consent form and obtain their 
signature. Study staff will tell family/friend participants they will be asked to join the 
patient participant and study Social Worker to talk about LDKT one time only and 
that their session will be audio recorded as described in their consent, which they 
can refuse at any time. Study staff will also tell family/friend participants they will 
complete a brief 5-10 minute in-person questionnaire after their meeting with the 
social worker to collect gender, race and ethnicity, date of birth, mailing address, if 
they are a current Duke employee, and social security number (required by Duke 
for payment of incentives) and ask what they thought of the meeting. 
Telephone SWI: Patient participants will be provided the call-in information for the 
the social worker session and asked to share with any family/friends they wish to 
join the call. Once family/friends join the call, Study staff will ask each family/friend 
to verify they are 18 or older, review the study and obtain verbal consent. 
Study staff will tell family/friends they will be asked to join the patient participant and 
study Social Worker in a telephone conference call to talk about LDKT one time 
only and that their session will be audio recorded as described in their consent, 
which they can refuse at any time. Study staff will also tell family/friends they will be 
asked to complete a brief 5-10 minute questionnaire immediately following the 
session (study staff will ask them to provide a contact number to call them as soon 
as the social worker session is over) to collect gender, race and ethnicity, date of 
birth, mailing address, if they are a current Duke employee, and social security 
number (required by Duke for payment of incentives) and ask what they thought of 
the session. Once the family/friend consents, study staff will document the date and 
time of the consent. 
2. TALK Social Worker Intervention
b) The patient participant and family/friend participant(s) will then meet with/talk to the
study Social Worker for up to one hour.
3. Assessments
c) In-Person SWI: Study staff will administer a brief 10-minute hardcopy
questionnaire immediately following the social worker session to obtain feedback
about the acceptability of the TALK SWI. We will provide assistance with reading
the questions and checking the responses if needed. Telephone SWI: Study staff
will 1) contact each consenting family/friend participant and administer the brief 10-
minute questionnaire via phone immediately following the social worker session;
and, 2) complete the paperwork required for payment.
d) Study staff will mail family/friend participants a thank you note and $20 check for
completing the questionnaire and session with the patient participant and study
social worker. 

C. Potential Live Donor Participants
Potential live donor participants will only become aware of the financial assistance 
program through direct referral by patient participants in Arm 3. Research study staff will 
not contact or attempt to contact any family, friends, or acquaintances of enrolled 
patient participants for any reason related to live kidney donation unless they 
contact us and express interest in the program. 
a. Patient participants in Arm 3 will be provided with information about the donor financial
assistance program by study staff following the completion of their first social worker
session (discussed in-person for In-person SWI and via phone for Telephone SWI).
Study staff will advise potential participants that they may provide this information to
potentially interested donors if they wish to, and that potentially interested donors
should contact the study team if they are interested in participating in the program.
They will be given pamphlets and forms with study contact information.
b. When potential donors contact study staff via telephone, study staff will discuss the
program. Study staff will also mail a brochure describing the financial assistance
program to potential donor(s) and forms required for possible reimbursements from our
program if they choose to take part.
c. Study staff will schedule a call back time to review the mailed materials and seek
participation if interested. Study staff will inform them that their participation in the
financial assistance program offered by this study may preclude them from receiving
financial assistance from any other federal, state or private program (e.g. National
Living Donor Assistance Center (NLDAC)). Each potential donor participant will be
offered a “bank” of $2,100 from which potential donors can receive reimbursement for
live kidney donation related expenses. While multiple people may step forward to be
evaluated for donation and incur expenses, the total amount available per patient study
participant is $2,100.
d. Study staff will contact those potential donors via telephone who requested a return call
to answer any questions and seek participation. Interested potential donors will then
undergo approved consent procedures and enroll in the study via telephone. We
anticipate that 70% of the 100 patient participants randomized to Arm 3 will have at
least one potential donor who will utilize the donor financial support program and will
therefore also be included as human subjects in this study (N=70). Study staff will
obtain potential donor participants’ gender, race and ethnicity, date of birth, mailing
address, telephone number, and if they are a current Duke employee (required by Duke
for payment of incentives).
e. Potential donors incurring eligible expenses will be asked to complete a Living Donor
Assistance Program Donor Worksheet summarizing expenses as well as sign an
attestation form to confirm that they understand the legal restrictions of the intervention.
This is required with each submission of receipts. Study staff will mail potential donors
checks reimbursing approved eligible expenses.
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