Optimizing Kidney Transplant Informed Consent
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01859884|
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|End-stage Kidney Disease||Behavioral: Inform Me: web-based education tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||November 2015|
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.
- Knowledge of increased risk donor kidney transplants [ Time Frame: 1 week ]Assess knowledge of increased risk donor kidneys
- Willingness to accept an increased risk donor kidney transplant [ Time Frame: 1 week ]Willingness to accept an increased risk donor kidney.
- Decisional conflict [ Time Frame: 1 week ]Will measure difficulty in treatment decision-making.
- Satisfaction with the informed consent process [ Time Frame: 1 week ]Assess decision-making quality, decision satisfaction, and perception of information.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|