Your Path to Transplant: A Randomized Control Trial of A Tailored Computer Education Intervention for Living Donor Kidney Transplant
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,White and Hispanic 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
|Official Title:||Computer Tailored Education Program to Reduce Disparities in Living Donor Kidney Transplant|
- Patient LDKT Attitude & Decision-Making Measure: Readiness [ Time Frame: up to 8 months post-Baseline ] [ Designated as safety issue: No ]Using validated measures, patients will be asked how ready they are to get a DDKT by reporting whether they are "not considering getting a DDKT in the next six months" (Precontemplation), "considering getting a DDKT in the next six months" (Contemplation), "preparing to get a DDKT in the next 30 days" (Preparation), "undergoing evaluation to get a DDKT" (Action) or "listed and waiting to get a DDKT" (Maintenance). Patients will also be asked how ready they are to pursue LDKT and to rate whether they are "not considering taking actions in the next six months to pursue LDKT" (Precontemplation), "considering taking actions in the next six months to pursue LDKT" (Contemplation), "preparing to take actions in the next 30 days to pursue LDKT" (Preparation), or "taking actions to pursue LDKT" (Action).
- Patient LDKT Attitude & Decision Making Measure: Decisional Balance [ Time Frame: up to 8 months post-Baseline ] [ Designated as safety issue: No ]Decisional Balance measures will assess how patients weigh the relative importance of possible LDKT and DDKT positive and negative outcomes (e.g., "My living donor will feel good seeing my health improve"). 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: up to 8 months post-Baseline ] [ Designated as safety issue: No ]The Self-Efficacy scale measures the confidence an individual has in his/her ability to pursue transplant 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".
- Patient LDKT Attitude & Decision Making Measure: Small Steps towards LDKT and DDKT [ Time Frame: up to 8 months post-Baseline ] [ Designated as safety issue: No ]To assess their steps toward transplant, patients will be asked to respond whether they have "Already done", "Are planning to do", or "Don't plan to do" a list of actions related to LDKT and DDKT. Examples of steps toward LDKT include "Read information/watch videos about getting a living donor transplant" and "Ask potential donors to be tested", while examples of steps toward DDKT include "Share educational materials about deceased donation with people in your life" and "Follow-up with the transplant coordinator until transplant evaluation is complete".
- 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"; "Compared to transplants from donors who have died, how long do transplants from living donors last?"). A measure of transplant knowledge is then created by summing the number of correct answers to the questions.
- Final Outcome: Pursuit of Transplant [ Time Frame: 18 months post-Baseline ] [ Designated as safety issue: No ]Finally, patients' electronic medical records at UCLA and data from the Scientific Registry for Transplant Recipients (SRTR) will be reviewed 18 months post-baseline to create a final study outcome for each patient. At the study's conclusion, the patient will be coded as to: 1) be waitlisted for a DDKT; 2) have received a DDKT; 3) have received a LDKT; 4) have been determined to be medically ineligible for transplant; 5) have died; or 6) have dropped out of evaluation.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (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
Patients will receive coaching and feedback over the phone and stag-appropriate educational materials (i.e. paphlets, brochures, personalized feedback report) based on their answers to the survey questions and where they are in their kidney transplant evaluation process.
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02181114
|Contact: Crystal S Anderson, MPHfirstname.lastname@example.org|
|Contact: John D Peipert, MA, MSWemail@example.com|
|United States, California|
|UCLA Division of Nephrology||Recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Crystal S Anderson, MPH 310-206-7243 firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Mark Robbins, PhD|
|Principal Investigator:||Amy D Waterman, PhD||University of California, Los Angeles|