Educating Missouri Patients About Preemptive Living Donor Transplantation

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; End Stage Renal Disease
• Interventions: Behavioral: Transplant education with video; Behavioral: Transplant education with speakers

• Registration Number: NCT01048437
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study is a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.

Detailed Description

Preemptive living donor transplant (PLDT), where renal patients get a living donor transplant before their kidneys fail, has better graft survival and lower mortality rates than living donor transplant following dialysis. However, not all renal patients and their living donors know about or consider living donation before a patient starts dialysis; To date, patients and donors presenting for PLDT are more likely to be Caucasian, of higher socioeconomic status, and more knowledgeable about transplant. To reach all patients newly diagnosed with kidney disease, the Missouri Kidney Program conducts a community Patient Education Program (PEP) outlining patients' transplant and dialysis options. Since 1994, approximately 2000 Missouri patients newly diagnosed with kidney disease and their family members have attended 2-day PEP classes. However, the current PEP transplant module does not significantly increase patients' willingness to pursue PLDT. Through a previous HRSA grant, Dr. Waterman designed the "Explore Transplant" education program based on Prochaska's Transtheoretical Model of Behavioral Change and her previous research to address key gaps in patients' living donation knowledge and to motivate patients to consider living donation. If funded, this study would conduct a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue PLDT and PLDT rates. Secondary objectives of the study are: (2) to increase rural and minority patients' access to transplant education, and (3) to describe racial, social, economic, and other influences affecting patients' PLDT willingness. The study design is a group-randomized controlled trial of 300 patients in 30 PEP classes in St. Louis, Springfield, and Kansas City, MO; patients and their family members in 15 classes will be randomized to receive the "Explore Transplant" education module, while 15 control classes will receive the traditional PEP transplant education. Across the education and control PEP classes we will compare: (1) increased willingness to pursue PLDT using baseline and follow-up attitudinal patient surveys, and (2) rates of living donation by tracking whether patients and their living donors present to any Missouri transplant center. At the conclusion of the study, we will have learned important information about how to reach and educate patients who have not yet begun dialysis and have developed a PLDT program that could be utilized in physicians' offices and by other organizations serving renal patients to increase living donation rates.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-13
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-13
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Chronic kidney disease
• Attend all 6 education modules
• 18+ years of age
• Have given consent by signing informed consent
• Speak and understand English
• Can read and understand questionnaires

Exclusion Criteria

• Patients who do not speak and understand English (material is presented orally)
• Patients who cannot read and understand the questionnaires
• Patients who are 17 years of age or younger

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transplant education with video	Transplant education with video	Explore Transplant transplant module featuring video
Transplant education with speakers	Transplant education with speakers	Explore Transplant transplant module featuring live guest speakers.

Primary Outcome Measures

Name	Time	Method
Willingness to pursue preemptive living donor transplant	pre and post-class

Secondary Outcome Measures

Name	Time	Method
Preemptive living donor transplant rates	1-2 years

Trial Locations

Locations (2)

Missouri Kidney Program; 🇺🇸 Warrensburg, Missouri, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States