Clinical trial NCT01048437: Educating Missouri Patients About Preemptive Living Donor Transplantation
Official title: Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Missouri Kidney Program
name: Health Resources and Services Administration (HRSA)
First posted: 2010-01-13
Enrollment: 370
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Willingness to pursue preemptive living donor transplant
timeFrame: pre and post-class
Secondary outcomes:
measure: Preemptive living donor transplant rates
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Missouri Kidney Program
state: Kansas
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Kidney Program
state: Missouri
city: Springfield
country: United States
facility: Missouri Kidney Program
state: Missouri
city: Warrensburg
country: United States
facility: Missouri Kidney Program
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Amy D Waterman, PhD
role: PRINCIPAL_INVESTIGATOR
References: