Educating Missouri Patients About Preemptive Living Donor Transplantation

Chronic Kidney Disease Clinical Trial

Official title:

Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048437
• Other study ID #: 080726
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: September 13, 2011
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Transplant education with video
1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors
• Transplant education with speakers
1 hour standard transplant module is replaced with the Explore Transplant presentation and 3 live speakers: 1 deceased donor recipient, 1 living donor recipient and 1 living donor

Locations

Country	Name	City	State
United States	Missouri Kidney Program	Overland Park	Kansas
United States	Missouri Kidney Program	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Missouri Kidney Program	Springfield	Missouri
United States	Missouri Kidney Program	Warrensburg	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Health Resources and Services Administration (HRSA), Missouri Kidney Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness to pursue preemptive living donor transplant		pre and post-class	No
Secondary	Preemptive living donor transplant rates		1-2 years	No