For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment. Moreover, living donor kidney transplantation (LDKT) offers numerous advantages over deceased donor kidney transplant such as better kidney quality, increased short- and long- term graft survival, lower rates of acute rejection, and reduced health care cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD patients four times more likely to receive a LDKT than African American ESRD patients. The long-term objective of this program of research is to understand the combined effect of a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.
The specific aims of the study are: (a) To develop and refine a web-based version of Living ACTS; (b) To conduct an outcome evaluation of the newly created web-based Living ACTS intervention by comparing the percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS compared to those who receive a control website with an embedded educational video; and (c) To conduct a process evaluation of the newly created web-based Living ACTS intervention by adapting commonly used process evaluation constructs (context, reach, dose received, fidelity, and recruitment) for an online environment. We will conduct a randomized controlled trial among a sample of 800 African American ESRD patients in the southeastern United States (ESRD Network 6 in Georgia and South Carolina), the region of the country with the largest proportion of African American ESRD patients on the waiting list. Patients will be randomly assigned to one of two study conditions (intervention or control). Participants at all four collaborating transplant centers will be seen by providers who utilize T-REX, thus allowing us to test the independent effect of individual-level education on a systems-level intervention. The primary outcome is the percent of patients with at least one living donor inquiry. Secondary outcomes will test the effect of the intervention on key constructs of the Information-Motivation-Behavioral Skills model to determine possible mediating pathways. Participants will undergo baseline assessment, access either the intervention or control educational materials, and complete an immediate follow-up assessment. Living donor inquiries will be examined over the subsequent 12 months. The process evaluation will utilize transplant center administrative records, immediate follow-up data from participants, website usage statistics, and study records. It is anticipated that achievement of these aims will yield outcomes with great clinical and public health impact.

Public Health Relevance

There are pervasive racial disparities in access to living donor kidney transplant, which for the majority of end stage renal disease patient represents the optimal treatment. The proposed study seeks to determine whether a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians coupled with culturally-sensitive individual level education is more effective at increasing access to living donor kidney transplant among African Americans than the systems-level intervention alone. In doing so, this study seeks to have a positive impact on public health and the vision of NIDDK, part of which is to seek insights and answers regarding health disparities in end stage renal disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK114891-03
Application #
9698344
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Serrano, Katrina Jane
Project Start
2017-08-01
Project End
2022-05-31
Budget Start
2019-06-01
Budget End
2020-05-31
Support Year
3
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Emory University
Department
Surgery
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322