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

NCT ID: NCT01776073

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-10-31

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.

Conditions

End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: BEHAVIORAL

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient Navigation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Rachel Patzer, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Patzer, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

Mason-01

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00060661

Identifier Type: -

Identifier Source: org_study_id