ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01776073
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Rachel Patzer, PhD, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
End-Stage Renal Disease Behavioral: Patient Navigation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
Study Start Date : January 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time from referral to evaluation appointment [ Time Frame: 1 year ]
  2. Time from referral to initial listing (active or inactive) [ Time Frame: 1 year ]
  3. Time from referral to transplant [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Rate of loss to follow-up; Rate of failure to show for evaluation appointment [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01776073


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

Responsible Party: Rachel Patzer, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01776073     History of Changes
Other Study ID Numbers: IRB00060661
Mason-01 ( Other Identifier: Other )
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Keywords provided by Rachel Patzer, PhD, Emory University:
Transplantation
Healthcare Disparities
Quality Assurance

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