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

NCT02181114 | Completed DMC

• 1 other identifier: DK088711-1
• Study Type: interventional
• Target: 815
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

Coaching; Educational Materials; Expert System; Living Donor Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Patient LDKT Attitude & Decision-Making Measure: Readiness

  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).

  up to 8 months post-Baseline

Secondary Outcomes (5)

• Patient LDKT Attitude & Decision Making Measure: Decisional Balance

  up to 8 months post-Baseline

• Patient LDKT Attitude & Decision Making Measure: Self-efficacy

  up to 8 months post-Baseline

• Patient LDKT Attitude & Decision Making Measure: Small Steps towards LDKT and DDKT

  up to 8 months post-Baseline

• Patient LDKT Attitude & Decision Making Measure: Transplant Knowledge

  up to 8 months post-Baseline

• Final Outcome: Pursuit of Transplant

  18 months post-Baseline

Study Arms (2)

Expert System Coaching

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Expert System Coaching BEHAVIORAL

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.

Expert System Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• University of Rhode Island: collaborator

Study Sites (2)

UCLA Division of Nephrology

Los Angeles, California, 90024, United States

Location

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Related Publications (2)

• Waterman AD, Peipert JD, Cui Y, Beaumont JL, Paiva A, Lipsey AF, Anderson CS, Robbins ML. Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant. Am J Transplant. 2021 Mar;21(3):1186-1196. doi: 10.1111/ajt.16262. Epub 2020 Sep 15.

  PMID: 33245618 DERIVED

• Waterman AD, Robbins ML, Paiva AL, Peipert JD, Kynard-Amerson CS, Goalby CJ, Davis LA, Thein JL, Schenk EA, Baldwin KA, Skelton SL, Amoyal NR, Brick LA. Your Path to Transplant: a randomized controlled trial of a tailored computer education intervention to increase living donor kidney transplant. BMC Nephrol. 2014 Oct 14;15:166. doi: 10.1186/1471-2369-15-166.

  PMID: 25315644 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy D Waterman, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Patient Engagement, Diversity, and Education

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 3, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

US (2)