A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 10/18/2018 |
| Start Date: | August 2007 |
| End Date: | December 2019 |
The main purpose of this study is to learn which educational method is most helpful to
patients and their family members when they consider whether to pursue live donor kidney
transplantation.
Patients who are eligible for a kidney transplant usually get information in the transplant
clinic about two types of kidney transplants - one where the kidney comes from a dead donor
and one where the kidney comes from a healthy living donor. Patients are given this
information by a transplant nurse or doctor and then encouraged to discuss it with family
members and friends.
In this study, we are trying to see if changing how and where we give patients this
information makes a difference in how patients and their family members think about live
donor kidney transplantation. So, we are looking at whether getting the information in the
transplant clinic - either alone or in a group - is the same or different than getting the
same information in your home.
The study is only recruiting African American patients. This is being done because African
Americans have a higher likelihood of developing chronic kidney disease and needing a kidney
transplant than patients of other races. However, they wait longer for a kidney transplant
and die at a higher rate on the waiting list because they are less likely than other patients
to receive a live donor kidney transplant. We want to see which educational approach works
best with African American patients and their families.
patients and their family members when they consider whether to pursue live donor kidney
transplantation.
Patients who are eligible for a kidney transplant usually get information in the transplant
clinic about two types of kidney transplants - one where the kidney comes from a dead donor
and one where the kidney comes from a healthy living donor. Patients are given this
information by a transplant nurse or doctor and then encouraged to discuss it with family
members and friends.
In this study, we are trying to see if changing how and where we give patients this
information makes a difference in how patients and their family members think about live
donor kidney transplantation. So, we are looking at whether getting the information in the
transplant clinic - either alone or in a group - is the same or different than getting the
same information in your home.
The study is only recruiting African American patients. This is being done because African
Americans have a higher likelihood of developing chronic kidney disease and needing a kidney
transplant than patients of other races. However, they wait longer for a kidney transplant
and die at a higher rate on the waiting list because they are less likely than other patients
to receive a live donor kidney transplant. We want to see which educational approach works
best with African American patients and their families.
Chronic kidney disease (CKD) affects over 10 million people in the United States. Diabetes,
hypertension, glomerulonephritis, and polycystic kidney disease contribute to most cases of
CKD. Those with CKD who become dialysis-dependent are considered to have ESRD. The incidence
of ESRD has increased dramatically over the last decade and is estimated to be 338 per
million population. Adults with ESRD are known to experience significant mortality and
morbidity, and there is evidence of significant health disparities between Whites and ethnic
minorities.
While kidney transplantation is the treatment of choice for patients with ESRD, the waiting
list and waiting time for deceased donor transplantation are expanding exponentially. Live
donor kidney transplantation (LDKT) remains a viable option for patients, yet more than half
of all wait-listed patients, especially minorities, do not pursue LDKT. Therefore, programs
designed to further expand LDKT, especially those targeting minority populations, are needed
given the current and projected shortage of deceased donor organs.
The long-term goal of this research program is to improve education provided to African
Americans and, thereby, increase rates of LDKT. The objective of this application is to
determine the relative effectiveness of three strategies for increasing LDKT in African
Americans. In a recently completed HRSA-funded (2002-2006) randomized clinical trial, we
demonstrated that a home-based LDKT intervention program was superior to standard
clinic-based education in increasing LDKT rates at one transplant center. The proposed study
seeks to replicate and extend the evaluation of a home-based (HB) educational intervention in
an African American patient population. The central hypothesis is that a HB intervention
yields higher LDKT rates relative to other interventions in African Americans. This
hypothesis has been formulated on the basis of strong preliminary data. The rationale for the
proposed research is that, by identifying the interventions most likely to yield higher LDKT
rates in African Americans, we can further develop and refine the interventional methodology
that will allow the most effective education to be disseminated to all kidney transplant
programs. We are especially well-prepared to conduct the proposed research due to the
multidisciplinary nature of the research team, as well as the expertise and experience of the
team in developing LDKT and live donation educational materials, implementing and evaluating
novel LDKT interventions, conducting LDKT research with African Americans, and producing
meaningful outcomes. Specifically, the research team includes investigators who are funded in
the conduct of ESRD, kidney transplantation, and organ donation research and who are
dedicated to the scientific advancement of LDKT. Also, the research will be conducted in an
environment that is conducive to the successful completion of this project.
To evaluate our central hypothesis and to accomplish the objective of the proposed study, we
plan to pursue the following two specific aims:
Specific Aim 1. Determine the clinical effectiveness of three separate LDKT educational
approaches with African American patients.
Recently, we found that an LDKT educational intervention delivered in the patient's home and
that involved both patients and their invited guests (family, friends, community leaders) was
an effective strategy for increasing LDKT, especially in African Americans. This is a very
different educational approach than what is used in most transplant centers, which typically
involves either group-based (patients and whomever accompanies them to clinic) meetings or
individual patient sessions. Based on the work summarized in the Preliminary Studies section,
the working hypothesis in this study is that patients randomized to a Home-Based (HB)
intervention will demonstrate more favorable outcomes relative to patients randomized to a
Group-Based (GB) intervention conducted in the transplant clinic or to a Standard Care (SC)
condition in which individual patients are education in the transplant clinic. Specifically,
relative to the GB or SC educational approaches, the HB intervention will demonstrate...
Primary Outcome:
Hypothesis 1.1: A higher proportion of enrolled patients with LDKTs.
Secondary Outcomes:
Hypothesis 1.2: A higher proportion of enrolled patients with live donor inquiries.
Hypothesis 1.3: A higher proportion of enrolled patients with live donor evaluations.
Hypothesis 1.4: A higher number of potential donors educated, per patient. Hypothesis 1.5:
More improvement in live donation knowledge. Hypothesis 1.6: More improvement in live
donation concerns. Hypothesis 1.7: More willingness to initiate live donor discussion with
others.
Specific Aim 2. Determine the sociodemographic, medical, and donation-specific variables that
are most strongly associated with pursuing LDKT.
Based on the work summarized in the Preliminary Studies section, the working hypothesis is
that LDKT status (primary outcome: yes/no) will vary significantly by sociodemographic,
medical, and donation-specific variables. Specifically… Hypothesis 2.1: The following patient
characteristics will be significantly associated with having received LDKT: male, younger,
dialysis-dependent, more live donor inquiries, more knowledge about live donation, fewer
concerns about live donation, and more willingness to initiate live donation discussion with
others.
hypertension, glomerulonephritis, and polycystic kidney disease contribute to most cases of
CKD. Those with CKD who become dialysis-dependent are considered to have ESRD. The incidence
of ESRD has increased dramatically over the last decade and is estimated to be 338 per
million population. Adults with ESRD are known to experience significant mortality and
morbidity, and there is evidence of significant health disparities between Whites and ethnic
minorities.
While kidney transplantation is the treatment of choice for patients with ESRD, the waiting
list and waiting time for deceased donor transplantation are expanding exponentially. Live
donor kidney transplantation (LDKT) remains a viable option for patients, yet more than half
of all wait-listed patients, especially minorities, do not pursue LDKT. Therefore, programs
designed to further expand LDKT, especially those targeting minority populations, are needed
given the current and projected shortage of deceased donor organs.
The long-term goal of this research program is to improve education provided to African
Americans and, thereby, increase rates of LDKT. The objective of this application is to
determine the relative effectiveness of three strategies for increasing LDKT in African
Americans. In a recently completed HRSA-funded (2002-2006) randomized clinical trial, we
demonstrated that a home-based LDKT intervention program was superior to standard
clinic-based education in increasing LDKT rates at one transplant center. The proposed study
seeks to replicate and extend the evaluation of a home-based (HB) educational intervention in
an African American patient population. The central hypothesis is that a HB intervention
yields higher LDKT rates relative to other interventions in African Americans. This
hypothesis has been formulated on the basis of strong preliminary data. The rationale for the
proposed research is that, by identifying the interventions most likely to yield higher LDKT
rates in African Americans, we can further develop and refine the interventional methodology
that will allow the most effective education to be disseminated to all kidney transplant
programs. We are especially well-prepared to conduct the proposed research due to the
multidisciplinary nature of the research team, as well as the expertise and experience of the
team in developing LDKT and live donation educational materials, implementing and evaluating
novel LDKT interventions, conducting LDKT research with African Americans, and producing
meaningful outcomes. Specifically, the research team includes investigators who are funded in
the conduct of ESRD, kidney transplantation, and organ donation research and who are
dedicated to the scientific advancement of LDKT. Also, the research will be conducted in an
environment that is conducive to the successful completion of this project.
To evaluate our central hypothesis and to accomplish the objective of the proposed study, we
plan to pursue the following two specific aims:
Specific Aim 1. Determine the clinical effectiveness of three separate LDKT educational
approaches with African American patients.
Recently, we found that an LDKT educational intervention delivered in the patient's home and
that involved both patients and their invited guests (family, friends, community leaders) was
an effective strategy for increasing LDKT, especially in African Americans. This is a very
different educational approach than what is used in most transplant centers, which typically
involves either group-based (patients and whomever accompanies them to clinic) meetings or
individual patient sessions. Based on the work summarized in the Preliminary Studies section,
the working hypothesis in this study is that patients randomized to a Home-Based (HB)
intervention will demonstrate more favorable outcomes relative to patients randomized to a
Group-Based (GB) intervention conducted in the transplant clinic or to a Standard Care (SC)
condition in which individual patients are education in the transplant clinic. Specifically,
relative to the GB or SC educational approaches, the HB intervention will demonstrate...
Primary Outcome:
Hypothesis 1.1: A higher proportion of enrolled patients with LDKTs.
Secondary Outcomes:
Hypothesis 1.2: A higher proportion of enrolled patients with live donor inquiries.
Hypothesis 1.3: A higher proportion of enrolled patients with live donor evaluations.
Hypothesis 1.4: A higher number of potential donors educated, per patient. Hypothesis 1.5:
More improvement in live donation knowledge. Hypothesis 1.6: More improvement in live
donation concerns. Hypothesis 1.7: More willingness to initiate live donor discussion with
others.
Specific Aim 2. Determine the sociodemographic, medical, and donation-specific variables that
are most strongly associated with pursuing LDKT.
Based on the work summarized in the Preliminary Studies section, the working hypothesis is
that LDKT status (primary outcome: yes/no) will vary significantly by sociodemographic,
medical, and donation-specific variables. Specifically… Hypothesis 2.1: The following patient
characteristics will be significantly associated with having received LDKT: male, younger,
dialysis-dependent, more live donor inquiries, more knowledge about live donation, fewer
concerns about live donation, and more willingness to initiate live donation discussion with
others.
Inclusion Criteria:
- African American race
- male or female
- 21 to 80 years old
- diagnosis of ESRD
- eligible for listing on the kidney transplant waiting list at Beth Israel Deaconess
Medical Center
- resides within 150 minutes of transplant center
- residential or cell phone service
- signed informed consent
Exclusion Criteria:
- Wait-listed for additional organ transplant (i.e., heart, liver)
- current substance abuse or dependency
- known or suspected psychotic disorder
- known or suspected mental retardation
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