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
  Purpose

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.


Condition Intervention
End-stage Kidney Disease
Behavioral: Inform Me: web-based education tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Knowledge of increased risk donor kidney transplants [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Assess knowledge of increased risk donor kidneys


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859884

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Rosyln B Mannon, MD    205-996-6383    rmannon@uab.edu   
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Elisa Gordon, PhD, MPH    312-503-5563    e-gordon@northwestern.edu   
Sponsors and Collaborators
Northwestern University
University of Alabama at Birmingham
Investigators
Principal Investigator: Elisa Gordon, PhD, MPH Northwestern University
  More Information

No publications provided

Responsible Party: Elisa Gordon, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01859884     History of Changes
Other Study ID Numbers: STU00055356
Study First Received: May 20, 2013
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 16, 2014