Optimizing Kidney Transplant Informed Consent

Not Applicable

Completed

• Conditions: End-stage Kidney Disease

• Registration Number: NCT01859884
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Study Start: 2013-10
• Primary Completion: 2014-12
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knowledge of increased risk donor kidney transplants	1 week	Assess knowledge of increased risk donor kidneys

Secondary Outcome Measures

Name	Time	Method
Willingness to accept an increased risk donor kidney transplant	1 week	Willingness to accept an increased risk donor kidney.

Trial Locations

Locations (2)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States