Optimizing Kidney Transplant Informed Consent

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Elisa Gordon, Northwestern University
ClinicalTrials.gov Identifier:
NCT01859884
First received: May 20, 2013
Last updated: February 17, 2014
Last verified: February 2014

May 20, 2013
February 17, 2014
October 2013
June 2014   (final data collection date for primary outcome measure)
Knowledge of increased risk donor kidney transplants [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Assess knowledge of increased risk donor kidneys
Knowledge of increased risk donor kidney transplants [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Assess knowledge of increased risk donor kidneys, risks, benefits, alternatives, and outcomes.
Complete list of historical versions of study NCT01859884 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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.
Same as current
 
Optimizing Kidney Transplant Informed Consent
Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
End-stage Kidney Disease
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.
  • 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.
    Intervention: Behavioral: Inform Me: web-based education tool
  • No Intervention: Control Standard of Care
    This group receives standard of care with a post test.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • English-speaking
  • 21 years or older
  • Kidney Transplant candidates eligible: 1) completed the first phase of transplant evaluation education, and 2) wait-listed patients expected to receive a transplant within the next 6 months, returning for re-evaluation.

Exclusion Criteria:

  • No special classes of study participants, including fetuses, neonates, prisoners, institutionalized individuals, or other vulnerable populations will be included in the proposed study. Although pregnant women will be eligible for participation in the study, they are unlikely to be selected for kidney transplantation.
Both
21 Years and older
No
Not Provided
United States
 
NCT01859884
STU00055356
Yes
Elisa Gordon, Northwestern University
Northwestern University
University of Alabama at Birmingham
Principal Investigator: Elisa Gordon, PhD, MPH Northwestern University
Northwestern University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP