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Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT02342119
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mary Amanda Dew, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
End-stage Kidney Disease Other: Talking About Living Kidney Donation Other: Kidney Transplant Fast Track Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation
Study Start Date : May 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KTFT+TALK
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
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 Name: TALK

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.
Other Name: KTFT

Active Comparator: KTFT+No TALK
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
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.
Other Name: KTFT




Primary Outcome Measures :
  1. Receipt of Kidney Transplant [ Time Frame: 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. ]
    This measure will assess whether or not the patient receives a kidney transplant


Secondary Outcome Measures :
  1. Time to complete transplant evaluation [ Time Frame: Assessed via medical record at completion of KT evaluation (Time 2) which can take up to one year from baseline ]
    We will use medical record data to measure the time from initiation of pre-KT workup to completing of kidney transplant evaluation

  2. Kidney Transplant Decision Making (assessed using increasing levels of preference for a living versus deceased donor) [ Time Frame: 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. ]
    Kidney transplant decision making will be assessed using increasing levels of preference for a living versus deceased donor with 7 items adapted from the Kidney Transplant Questionnaire.

  3. Booklet and video helpfulness (assess perceptions of the quality and helpfulness of the video and booklet) [ Time Frame: Assessed at completion of evaluation (Time 2) which can take place up to one year from baseline. ]
    For participants in the TALK condition, we will assess perceptions of the quality and helpfulness of the video and booklet.

  4. Quality of Life (KDQOL-SF) [ Time Frame: Assessed at completion of evaluation (Time 2) which can take place up to one year from baseline. ]
    We will use the KDQOL-SF to measure QOL. The SF-36 serves as the generic core of this measure. The KDQOL also includes items relevant to patients with kidney disease.

  5. Type of transplant (whether the patient receives a Living or Deceased Donor Kidney Transplant) [ Time Frame: 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. ]
    This measure will assess whether the patient receives a Living or Deceased Donor Kidney Transplant



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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342119


Contacts
Contact: Kellee R Bornemann, BA 412-692-2678 Bornemannk@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kellee R Bornemann, BA    412-692-2678    krb28@pitt.edu   
Principal Investigator: Mary Amanda Dew, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mary Amanda Dew, PhD University of Pittsburgh

Responsible Party: Mary Amanda Dew, Mary Amanda Dew, PhD, Professor of Psychiatry, Psychology, Epidemiology, Biostatistics, and Clinical and Translational Science, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02342119     History of Changes
Other Study ID Numbers: PRO13100511
5R01DK101715-04 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mary Amanda Dew, University of Pittsburgh:
kidney transplantation
race disparities
living donor kidney transplantation
transplant evaluation

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