Optimizing Kidney Transplant Informed Consent

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01859884

Collaborator

University of Alabama at Birmingham (Other)

288

Enrollment

Locations

Arms

Duration (Months)

144

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Kidney Disease	Behavioral: Inform Me: web-based education tool	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Health Services Research

Official Title:

Optimizing Kidney Transplant Patients' Informed Consent for Increased Risk Donors

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Knowledge of increased risk donor kidney transplants [1 week]
Assess knowledge of increased risk donor kidneys

Secondary Outcome Measures

Willingness to accept an increased risk donor kidney transplant [1 week]
Willingness to accept an increased risk donor kidney.

Other Outcome Measures

Decisional conflict [1 week]
Will measure difficulty in treatment decision-making.
Satisfaction with the informed consent process [1 week]
Assess decision-making quality, decision satisfaction, and perception of information.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.