Optimizing Kidney Transplant Informed Consent
The objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. We have developed a web-based tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone for kidney transplant.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
|Official Title:||Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors|
- Knowledge of increased risk donor kidney transplants [ Time Frame: 1 week ] [ Designated as safety issue: No ]Assess knowledge of increased risk donor kidneys
- Willingness to accept an increased risk donor kidney transplant [ Time Frame: 1 week ] [ Designated as safety issue: No ]Willingness to accept an increased risk donor kidney.
- Decisional conflict [ Time Frame: 1 week ] [ Designated as safety issue: No ]Will measure difficulty in treatment decision-making.
- Satisfaction with the informed consent process [ Time Frame: 1 week ] [ Designated as safety issue: No ]Assess decision-making quality, decision satisfaction, and perception of information.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Inform Me: web-based education tool
Intervention will receive the standard of care, the Inform Me intervention, a post-test evaluation, and 1 week recall test.
Behavioral: Inform Me: web-based education tool
The purpose of Inform Me is to help kidney transplant candidates understand what kidneys from increased risk donors are and describes the risks and benefits of accepting and refusing a kidney from an increased risk donor. Increased risk donors are donors who engaged in behaviors that increase their chances of having: Human Immunodeficiency Virus, Hepatitis B Virus , Hepatitis C Virus. Inform Me focuses only on increased risk donor kidneys. Inform Me aims to prepare patients to make a decision with their transplant team to accept or to refuse a kidney from an increased risk donor. Inform Me does not try to convince patients to accept or refuse a kidney from increased risk donors.
No Intervention: Control Standard of Care
This group receives standard of care with a post test.
The shortage of kidneys for kidney transplantation 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 candidates kidneys that come from donors who have an increased risk of transmission of human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C. Increased risk kidney donors are defined as those who have engaged in behaviors associated with an increased risk of HIV, Hepatitis B, and Hepatitis C, and comprise approximately 9% of all US deceased organ donors. The Organ Procurement and Transplantation Network policy mandated informed consent from recipients who accept increased risk kidneys. The objective of this study is to increase study participants' comprehension about increased risk donor kidneys necessary for informed consent. To accomplish this objective, we will develop a web-based tool that educates and assesses participants' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone. The tool will utilize health information technology to deliver information about the definition of, risks, benefits, and alternatives to using increased risk donor kidneys via a web-based application. Computer adaptive learning will personalize information presented to each candidate according to his/her comprehension levels in interactive chapters to increase comprehension. Inform Me will facilitate nurses' primary role as patient educators.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859884
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Elisa Gordon, PhD, MPH||Northwestern University|