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

NCT01776073 | Completed DMC

• 2 other identifiers: IRB00060661Mason-01
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease

Keywords

Transplantation; Healthcare Disparities; Quality Assurance

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (3)

• Time from referral to evaluation appointment

  1 year

• Time from referral to initial listing (active or inactive)

  1 year

• Time from referral to transplant

  1 year

Other Outcomes (1)

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

  1 year

Study Arms (2)

Patient navigation

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

Patient Navigation BEHAVIORAL

Patient navigation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Rachel Patzer, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

US (1)