Optimizing Kidney Transplant Informed Consent



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:November 2015

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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.

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.
We found this trial at
2
sites
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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