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

Not Applicable

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Behavioral: Patient Navigation

• Registration Number: NCT01776073
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-24
• Study First Posted: 2013-01-25
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

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

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Exclusion Criteria

• There are no exclusion criteria that would limit subject participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient navigation	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

Primary Outcome Measures

Name	Time	Method
Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion	1 year

Secondary Outcome Measures

Name	Time	Method
Time from referral to initial listing (active or inactive)	1 year
Time from referral to evaluation appointment	1 year
Time from referral to transplant	1 year

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States