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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients|
- Time from evaluation to waitlisting in referred patients; Rate of pre-transplant evaluation completion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time from referral to evaluation appointment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time from referral to initial listing (active or inactive) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time from referral to transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Rate of loss to follow-up; Rate of failure to show for evaluation appointment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: 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
|Behavioral: Patient Navigation|
No Intervention: Standard of Care
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776073
|Contact: Mohua Basu, MPHfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Mohua Basu 404-712-0735 email@example.com|
|Principal Investigator: Rachel Patzer, PhD, MPH|
|Sub-Investigator: Mohua Basu, MPH|
|Sub-Investigator: Rachel Koval, MPH|
|Principal Investigator:||Rachel Patzer, PhD, MPH||Emory University|