Optimizing Kidney Transplant Informed Consent

NCT01859884 | Completed DMC

• 1 other identifier: STU00055356
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Knowledge of increased risk donor kidney transplants

  Assess knowledge of increased risk donor kidneys

  1 week

Secondary Outcomes (1)

• Willingness to accept an increased risk donor kidney transplant

  1 week

Other Outcomes (2)

• Decisional conflict

  1 week

• Satisfaction with the informed consent process

  1 week

Study Arms (2)

Inform Me: web-based education tool

EXPERIMENTAL

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

Control Standard of Care

NO INTERVENTION

This group receives standard of care with a post test.

Interventions

Inform Me: web-based education tool BEHAVIORAL

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.

Inform Me: web-based education tool

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 27463536 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Acquired Immunodeficiency Syndrome; Hepatitis B; Hepatitis C; Communicable Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections

Study Officials

• Elisa Gordon, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 22, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (2)