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OpenTrials
Completed

NCT Number: NCT01776073

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Behavioral

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  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 outcomes

  1. Rate of loss to follow-up; Rate of failure to show for evaluation appointment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2013
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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