The shortage of kidneys for KT results in almost 10,000 deaths per year in the United States. One strategy to increase the number of available kidneys is to offer kidney transplant (KT) candidates kidneys at increased risk (IR) of transmission of human immunodeficiency virus (HIV), hepatitis B (HBV) and C (HCV), as defined using the 1994 US Public Health Service (PHS) guidelines for preventing infectious disease transmissions. IR donors are defined as those who have engaged in behaviors associated with an increased risk of HIV and HCV transmissions, and comprise approximately 9 percent of all US deceased organ donors. However, following an unexpected transmission of HIV and HCV from an IR deceased donor to 4 recipients in 2007, OPTN policy and Center for Medicare and Medicaid Services (CMS) conditions of participation mandated informed consent from recipients who accept IR kidneys. Despite the requirements for specific informed consent, neither OPTN nor CMS offer guidance about how or what information should be disclosed to potential recipients. As a result, the current informed consent processes provide varying levels of information about IR donors. Further, KT candidates have been found to misunderstand what IR donors are and desire more information about IR donor kidneys than provided. Low literacy levels of KT candidates may limit their understanding of IR donor kidneys. The objective of this study is to increase KT candidates'comprehension about IR kidneys necessary for providing informed consent. To accomplish this objective, we will develop a web-based tool that educates and assesses candidates'comprehension (iGetIR), as a supplement to current informed consent processes. We will then conduct an RCT to compare the effectiveness of the current informed consent processes (controls) with the current consent processes supplemented by iGetIR. The tool will utilize health information technology to deliver information to candidates about the definition of, risks, benefits, and alternatives to using IR kidneys via a web-based application. We will develop educational materials by transforming infectious risk data into easy to comprehend information using adult learning theory, health communication best practices, and health literacy universal precautions. As part of this innovative informed consent process, computer adaptive learning will personalize information according to each candidate's comprehension levels in interactive chapters to increase comprehension. Given OPTN's and CMS's mandate, it is a priority of the transplant community to develop educational tools to improve the current informed consent process, and we are unaware of any interventions that address this need. Because transplant nurses play a central role in the multidisciplinary approach to the patient education and informed consent processes for KT, this study proposes to capitalize on their knowledge and expertise by supplementing the current informed consent processes.

Public Health Relevance

The proposed study will develop a web-based tool that educates and assesses kidney transplant candidates'comprehension of increased risk donor kidneys (iGetIR). We will then compare the effectiveness of the current informed consent processes supplemented by iGetIR, with the current consent processes alone for kidney transplant candidates. A standardized and personalized informed consent process will improve kidney transplant candidates'comprehension and enhance autonomous decision-making, while helping transplant centers meet current OPTN and CMS mandates for patient education and informed consent, specifically for increased risk donor kidneys.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21NR013660-01
Application #
8341357
Study Section
Special Emphasis Panel (ZRG1-RPHB-P (50))
Program Officer
Tully, Lois
Project Start
2012-07-04
Project End
2014-06-30
Budget Start
2012-07-04
Budget End
2013-06-30
Support Year
1
Fiscal Year
2012
Total Cost
$240,047
Indirect Cost
$84,677
Name
Northwestern University at Chicago
Department
Surgery
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
Gordon, Elisa J; Ison, Michael G (2014) Decision aids for organ transplant candidates. Liver Transpl 20:753-5