Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation

Completed · Not applicable

Conditions studied: End-stage Kidney Disease

In brief

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.

Key facts

Study ID

NCT02342119

Run by

University of Pittsburgh

People needed

1315

Starts

2015-05-01

Expected to finish

2020-08-01

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have scheduled a kidney transplant evaluation appointment at the Starzl Transplant Institute at the University of Pittsburgh Medical Center.
• Male or female
• English speaking
• ESKD patients aged 18 and over
• Patient has not previously received a kidney transplant
• Patient has not been accepted for kidney transplant in another center

You may not qualify if…

• Prior kidney transplant (excluded to eliminate the possibility that past experiences would affect their current treatment decisions)
• Patient is already on the United Network for Organ Sharing (UNOS) waiting list through another center
• Children under age 18 will be excluded because they have dissimilar underlying conditions, response patterns and decision-making authority as a result of their developmental stage and dependency on adult guardians.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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