Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Rachel Patzer, PhD, Emory University Identifier:
First received: January 23, 2013
Last updated: November 25, 2014
Last verified: November 2014

The purpose of this study is to measure the effect of introducing a patient navigator to guide high and moderate risk patients through the pre-waitlisting phases of the kidney transplant process. Patients identified as being at high and moderate risk of delay to waitlisting will be linked with a patient navigator, who will facilitate their completion of pre-waitlisting requirements. We believe that patients who are randomized to a patient navigator will be more likely to complete the pre-waitlisting process and will complete the process more quickly than high and moderate risk patients who do not receive additional assistance from a patient navigator.

Condition Intervention
End-Stage Renal Disease
Behavioral: Patient Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from referral to evaluation appointment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time from referral to initial listing (active or inactive) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time from referral to transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Rate of loss to follow-up; Rate of failure to show for evaluation appointment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient navigation
In addition to receiving the standard of care, these patients will be connected with a patient navigator who will provide personalized assistance with regard to completion of the pre-waitlisting process
Behavioral: Patient Navigation
No Intervention: Standard of Care
These patients will receive the standard of care, which includes assistance from the current Emory Transplant Center team of social workers, physicians, and other support staff with regard to completion of the pre-waitlisting process

Detailed Description:

The investigators plan to implement a newly developed risk assessment tool that uses medical and demographic indicators to estimate the probability of waitlisting for all patients beginning the transplant process at the Emory Transplant Center. Medical secretaries will collect information about patients' medical and demographic characteristics during the appointment scheduling phone call. This information will be entered into the REDCap risk assessment tool, which will be used to calculate the probability of waitlisting. A previously defined cut-off will be used to categorize the risk of delay to waitlisting.

A random subset of patients identified as being at high and moderate risk of delay to waitlisting will be connected with a patient navigator, who will be available not only to answer questions, but also to manage clinical information prior to, during, and following transplantation. The navigator will work to identify potential barriers and to ensure that the most up-to-date clinical information has garnered responses at the nurse and physician levels.

The effect of connecting high and moderate risk patients with a patient navigator on time to waitlisting and rate of waitlisting will be analyzed to determine whether such a program is an effective means of increasing access to transplant for patients who are likely to face financial, racial, and demographic barriers.


Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Kidney transplant candidates older than 18 years of age at Emory Transplant Center

Exclusion Criteria:

  • There are no exclusion criteria that would limit subject participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01776073

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Rachel Patzer, PhD, MPH Emory University
  More Information

No publications provided

Responsible Party: Rachel Patzer, PhD, Assistant Professor, Emory University Identifier: NCT01776073     History of Changes
Other Study ID Numbers: IRB00060661, Mason-01
Study First Received: January 23, 2013
Last Updated: November 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Healthcare Disparities
Quality Assurance

Additional relevant MeSH terms:
Kidney Failure, Chronic
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases processed this record on February 27, 2015