Clinical trial NCT01776073: Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
Official title: Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: Transplantation
Healthcare Disparities
Quality Assurance
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion
timeFrame: 1 year
Secondary outcomes:
measure: Time from referral to evaluation appointment
timeFrame: 1 year
measure: Time from referral to initial listing (active or inactive)
timeFrame: 1 year
measure: Time from referral to transplant
timeFrame: 1 year
Other outcomes:
measure: Rate of loss to follow-up; Rate of failure to show for evaluation appointment
timeFrame: 1 year
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Rachel Patzer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: