Clinical trial NCT01859884: Optimizing Kidney Transplant Informed Consent
Official title: Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Kidney Disease
Keywords: Kidney transplantation
Increased risk donor kidneys
Kidney donation
Organ donation
Human Immunodeficiency Virus
Hepatitis B
Hepatitis C
Infectious disease
Disease transmission
Centers for Disease Control (CDC)
Web-based intervention
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2013-05-22
Enrollment: 288
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge of increased risk donor kidney transplants
timeFrame: 1 week
Secondary outcomes:
measure: Willingness to accept an increased risk donor kidney transplant
timeFrame: 1 week
Other outcomes:
measure: Decisional conflict
timeFrame: 1 week
measure: Satisfaction with the informed consent process
timeFrame: 1 week
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Elisa Gordon, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gordon EJ, Sohn MW, Chang CH, McNatt G, Vera K, Beauvais N, Warren E, Mannon RB, Ison MG. Effect of a Mobile Web App on Kidney Transplant Candidates' Knowledge About Increased Risk Donor Kidneys: A Randomized Controlled Trial. Transplantation. 2017 Jun;101(6):1167-1176. doi: 10.1097/TP.0000000000001273.