Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation

NCT02342119 | Completed

• 2 other identifiers: PRO131005115R01DK101715-04
• Study Type: interventional
• Target: 1,315
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

kidney transplantation; race disparities; living donor kidney transplantation; transplant evaluation

Outcome Measures

Primary Outcomes (1)

• Receipt of Kidney Transplant

  This measure will assess whether or not the patient receives a kidney transplant

  Assessed via Post- transplant medical record review. An average time period to receive transplant and assess this outcome is approximately 43.6 months from baseline.

Secondary Outcomes (5)

• Time to complete transplant evaluation

  Assessed via medical record at completion of KT evaluation (Time 2) which can take up to one year from baseline

• Kidney Transplant Decision Making (assessed using increasing levels of preference for a living versus deceased donor)

  Assessed twice. First at initiation of pre-KT workup (Time 1) which is baseline. And next at the completion of evaluation (Time 2) which can take place up to one year from baseline.

• Booklet and video helpfulness (assess perceptions of the quality and helpfulness of the video and booklet)

  Assessed at completion of evaluation (Time 2) which can take place up to one year from baseline.

• Quality of Life (KDQOL-SF)

  Assessed at completion of evaluation (Time 2) which can take place up to one year from baseline.

• Type of transplant (whether the patient receives a Living or Deceased Donor Kidney Transplant)

  Assessed via Post- transplant medical record review. An average time period to receive transplant and assess this outcome is approximately 43.6 months from baseline.

Study Arms (2)

KTFT+TALK

EXPERIMENTAL

Patients who are being evaluated for a kidney transplantation via Kidney Transplant Fast Track and who are receiving the Talking About Living Kidney Donation intervention

Other: Talking About Living Kidney Donation; Other: Kidney Transplant Fast Track

KTFT+No TALK

ACTIVE COMPARATOR

Patients who are being evaluated for a kidney transplantation via Kidney Transplant Fast Track and who are not receiving the Talking About Living Kidney Donation intervention

Other: Kidney Transplant Fast Track

Interventions

Talking About Living Kidney Donation OTHER

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.

Also known as: TALK

KTFT+TALK

Kidney Transplant Fast Track OTHER

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.

Also known as: KTFT

KTFT+No TALK; KTFT+TALK

Eligibility Criteria

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

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Myaskovsky L, Leyva Y, Puttarajappa C, Kalaria A, Ng YH, Velez-Bermudez M, Zhu Y, Bryce C, Croswell E, Wesselman H, Kendall K, Chang CC, Boulware LE, Tevar A, Dew MA. Kidney Transplant Fast Track and Likelihood of Waitlisting and Transplant: A Nonrandomized Clinical Trial. JAMA Intern Med. 2025 May 1;185(5):499-509. doi: 10.1001/jamainternmed.2025.0043.

  PMID: 40063052 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

• Mary Amanda Dew, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Amanda Dew, PhD, Professor of Psychiatry, Psychology, Epidemiology, Biostatistics, and Clinical and Translational Science

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 19, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: August 1, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

US (1)