Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation

Summary

Living donor kidney transplantation (LDKT) is the optimal treatment for end-stage kidney disease (ESKD). But, the evaluation process for a kidney transplant is lengthy, time consuming, and burdensome to the patient. Also, race disparities exist in rates of transplant evaluation completion, transplantation, and LDKT. Our previous and ongoing NIDDK-funded research indicates that cultural factors (i.e., perceived discrimination in health care, religious objection to LDKT), transplant knowledge, and demographic characteristics (e.g., age, education, income) independently and significantly predict time to complete transplant evaluation. In December 2012 the investigators' transplant center implemented a one-day streamlined evaluation process, dubbed Kidney Transplant Fast Track (KTFT), but it has not been evaluated for efficacy or cost effectiveness. Thus, the investigators propose a quasi-experiment to determine the efficacy and cost-effectiveness of the KTFT (n=1030) compared to historical controls (n=1140) who were recruited for the investigators' current NIDDK study to increase transplant rates. At the same time, the investigators will conduct a randomized controlled trial (RCT) targeting vulnerable patients with the educational component of the TALK intervention (Talking About Live Kidney Donation) to increase LDKT. For both components of the proposal, the investigators will target vulnerable populations because they are most at risk for extended evaluation times and lower rates of LDKT. Using CONSORT standards, participants will be randomly assigned to TALK (n=515) versus no-TALK (n=515) conditions and undergo two interviews at pre-transplant work-up and at completion of transplant evaluation in order to: (1) test whether KTFT and TALK will reduce transplant evaluation time, and increase rates of transplant and LDKT in members of vulnerable groups; (2) determine whether engaging in a streamlined and coordinated-care evaluation experience within the transplant center reduces negative perceptions of the healthcare system; and (3) test the cost effectiveness of the KTFT with TALK relative to standard practices. The results of this two-pronged approach will help pave the way for other transplant centers to implement a fast-track system at their sites, improve quality of care by transplanting a larger number of vulnerable patients, and may help address stark race/ethnic disparities in rates of LDKT.

Conditions

• End-stage Kidney Disease

Interventions

OTHER

Talking About Living Kidney Donation

TALK participants receive a culturally sensitive educational booklet and video. A study interventionist encourages participants to share the materials with their family members or friends. Materials provide information to encourage patient and families shared and informed consideration of LDKT, including: 1) information about eligibility for LDKT, 2) the clinical evaluation required for LDKT, 3) the donor selection process, 4) surgical procedures for transplantation and donation, 5), and concerns brought forth about these factors, identified through structured group interviews.

OTHER

Kidney Transplant Fast Track

KTFT is a one-day streamlined transplant evaluation process. Every patient who is evaluated at the University of Pittsburgh Starzl Transplant Center receives the KTFT. This approach involves completion of most or all testing on the same day that patients arrive for their first pre-transplant clinic appointment, rather than providing them with a list of tests they complete on their own with their referring physician. If patients are unable to be scheduled the same day, the transplant clinic scheduler secures appointment times and preparatory material for all testing to be completed within a 2 week period.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Mary Amanda Dew, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-01

Primary Completion

2019-12-31

Completion

2020-08-31

Countries

• United States

Study Locations