Overview

This trial is active, not recruiting.

Condition end-stage renal disease
Treatment patient navigation
Sponsor Emory University
Start date January 2013
End date October 2017
Trial size 800 participants
Trial identifier NCT01776073, IRB00060661, Mason-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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
patient navigation
(No Intervention)
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 Outcomes

Measure
Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion
time frame: 1 year

Secondary Outcomes

Measure
Time from referral to evaluation appointment
time frame: 1 year
Time from referral to initial listing (active or inactive)
time frame: 1 year
Time from referral to transplant
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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

Additional Information

Official title Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
Principal investigator Rachel Patzer, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Emory University.