Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
Primary Purpose
End-Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
About this trial
This is an interventional supportive care trial for End-Stage Renal Disease focused on measuring Transplantation, Healthcare Disparities, Quality Assurance
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
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient navigation
Standard of Care
Arm Description
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
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
Outcomes
Primary Outcome Measures
Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion
Secondary Outcome Measures
Time from referral to evaluation appointment
Time from referral to initial listing (active or inactive)
Time from referral to transplant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01776073
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Transplantation, Healthcare Disparities, Quality Assurance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient navigation
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Primary Outcome Measure Information:
Title
Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time from referral to evaluation appointment
Time Frame
1 year
Title
Time from referral to initial listing (active or inactive)
Time Frame
1 year
Title
Time from referral to transplant
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Rate of loss to follow-up; Rate of failure to show for evaluation appointment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Patzer, PhD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
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