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Your Path to Transplant: A Randomized Control Trial of A Tailored Computer Education Intervention for Living Donor Kidney Transplant

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University of California, Los Angeles
Sponsor:
Collaborator:
University of Rhode Island
Information provided by (Responsible Party):
Amy D. Waterman, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02181114
First received: June 27, 2014
Last updated: January 12, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Behavioral: Expert System Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Patient LDKT Attitude & Decision-Making Measure: Readiness [ Time Frame: up to 8 months post-Baseline ]
    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).


Secondary Outcome Measures:
  • Patient LDKT Attitude & Decision Making Measure: Decisional Balance [ Time Frame: up to 8 months post-Baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Estimated Enrollment: 900
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)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identify as Black, White, or Hispanic
  • Must not have been deemed kidney transplant ineligible by UCLA Kidney and Pancreas Transplant Program
  • Cannot be listed at another transplant center
  • Can read English

Exclusion Criteria:

  • Does not self-identify as Black, White, or Hispanic
  • Deemed ineligible to receive a kidney transplant by UCLA Kidney and Transplant Program
  • Listed at another transplant center
  • Cannot read English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02181114

Contacts
Contact: Crystal S Anderson, MPH 310-206-7243 csanderson@mednet.ucla.edu
Contact: John D Peipert, MA, MSW 310-206-4750 jpeipert@mednet.ucla.edu

Locations
United States, California
UCLA Division of Nephrology Recruiting
Los Angeles, California, United States, 90024
Contact: Crystal S Anderson, MPH    310-206-7243    csanderson@mednet.ucla.edu   
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    markrobb@uri.edu   
Sub-Investigator: Mark Robbins, PhD         
Sponsors and Collaborators
University of California, Los Angeles
University of Rhode Island
Investigators
Principal Investigator: Amy D Waterman, PhD University of California, Los Angeles
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy D. Waterman, Associate Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02181114     History of Changes
Obsolete Identifiers: NCT01553864
Other Study ID Numbers: DK088711-1 
Study First Received: June 27, 2014
Last Updated: January 12, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of California, Los Angeles:
Coaching
Educational Materials
Expert System
Living Donor Kidney Transplant

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 20, 2017