Your Path to Transplant: A Randomized Control Trial of A Tailored Computer Education Intervention for Living Donor Kidney Transplant (YPT)
Because of the deceased donor organ shortage, more kidney patients are considering whether to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they are less likely to receive LDKTs. To address this disparity, this randomized controlled trial will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can be increased when they receive access to the Your Path to Transplant computerized Expert System (YPT). This trial will also examine how other known patient, family, and healthcare system barriers to LDKT impact YPT's effectiveness.
Nine hundred (900) Black and White ESRD patients presenting for transplant medical evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored feedback reports, coaching, and socioeconomic resource guidance associated with reducing barriers to access to LDKT. Control patients will receive usual care transplant education provided by UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and self-efficacy will be assessed at four time points: prior to presenting at the transplant center (baseline), during transplant evaluation (approximately 2 months post-baseline), and 4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will be assessed 18-months post-baseline.
At the conclusion of the study, we will have developed an innovative and cost-effective YPT Computerized Expert System that could be utilized to tailor LDKT discussion and education in different medical settings based on the needs of individual patients of different races.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
- Patient LDKT Attitude & Decision-Making Measure: Demographics and Personality Variables [ Time Frame: Baseline ] [ Designated as safety issue: No ]Demographic information for patients will be collected via survey questions that assess the patient's age, gender, ethnicity distance from the transplant center, type of health insurance received, and education and income levels.
- Patient LDKT Attitude & Decision Making Measure: Transplant Knowledge [ Time Frame: up to 8 months post-Baseline ] [ Designated as safety issue: No ]Patients will be asked 11 true/false and 8 multiple choice questions to determine their level of knowledge regarding basic facts, advantages, risks and outcomes of DDKT and LDKT (e.g., Patients older than 80 years can receive transplants (true); Compared to transplants from donors who have died, how long do transplants from living donors last?)
- Patient LDKT Attitude & Decision Making Measure: LDKT Readiness and Offers [ Time Frame: up to 8 months post-Baseline ] [ Designated as safety issue: No ]Patients will report whether they are either "not considering getting a living donor transplant in the next six months" (Precontemplation), "considering taking actions to get a living donor transplant in the next six months" (Contemplation), "preparing to take actions to get a living donor transplant in the next 30 days" (Preparation), or "taking actions to get a living donor transplant" (Action). Patients will also be asked if they have family members and friends who might consider being living donors (yes/no) and how many living donors have offered to be evaluated, undergone evaluation, been ruled out, or matched them
- Patient LDKT Attitude & Decision Making Measure:Decisional Balance [ Time Frame: Baseline ] [ Designated as safety issue: No ]A Decisional Balance measure provides information about the relative importance an individual places on possible LDKT positive and negative outcomes (e.g., "The surgery would be too painful or stressful for the donor"; "Most living donors say they are very glad they donated and would do it again"). Patients will be asked to rate the importance of each statement on a 5-point scale ranging from, (1) "Not important" to (5) "Extremely important."
- Patient LDKT Attitude & Decision Making Measure:Self-Efficacy [ Time Frame: Baseline ] [ Designated as safety issue: No ]The Self-Efficacy scale measures the confidence an individual has in his or her ability to pursue an LDKT in a wide variety of challenging situations (e.g., "If Your friends and family were unsupportive of you getting a transplant") on a scale from (1) "Not at all confident" to (5) "Completely confident."
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Expert System Coaching
Patients in the intervention group will receive coaching based off the answers provided in the computer-based Expert System that is designed to track their readiness level to pursue a living donor kidney transplant
|Behavioral: Expert System Coaching|
No Intervention: Control
Patients in the control group will only receive the standard of care education that is offered at the UCLA Kidney and Pancreas Transplant Center which consists of a powerpoint presentation on their Evaluation Day appointment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02181114
|Contact: Crystal S Kynard-Amerson, MPHemail@example.com|
|Contact: John D Peipert, MA, MSWfirstname.lastname@example.org|
|United States, California|
|UCLA Division of Nephrology||Recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Crystal S Kynard-Amerson, MPH 310-206-7243 email@example.com|
|Principal Investigator: Amy D Waterman, PhD|
|United States, Rhode Island|
|University of Rhode Island||Recruiting|
|Kingston, Rhode Island, United States, 02881|
|Contact: Mark Robbins, PhD 401-874-5082 firstname.lastname@example.org|
|Sub-Investigator: Mark Robbins, PhD|