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Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805038
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : July 15, 2011
Last Update Posted : July 15, 2011
Information provided by:
Case Western Reserve University

Brief Summary:

Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and poor patients with End Stage Renal Disease have decreased access to kidney transplantation. In prior work, the investigators identified the steps in the transplant process that are responsible for creating these disparities. These include medical suitability, interest in receiving a transplant, referral to a transplant center for a pre-transplant workup, placement on a waiting list or identification of a living donor, and receipt of a kidney from a deceased or living donor. The investigators now propose to train transplant recipients to act as transplant navigators and then test the value of using transplant navigators to help patients and providers complete these steps.

The proposed community-based randomized controlled trial will involve approximately 75-100 adult hemodialysis patients at intervention dialysis facilities and approximately 75-100 patients at control facilities to compare a transplant navigator intervention with usual care over a 24 month interval. Baseline evaluation will include sociodemographic and medical characteristics, specific steps completed in the transplant process, and barriers to moving forward in the transplant process. At periodic intervals, the navigator will provide tailored information and assistance to patients and their nephrologists to help them complete the tasks required at each step. The major outcome will be completion of additional steps in the transplant process. Secondary analyses will examine impediments to successful intervention among subjects who fail to move forward in the transplant process despite assistance from a navigator.

The proposed project will test a novel intervention that targets patients and nephrologists as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Behavioral: Transplant navigator Behavioral: Usual care Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
Study Start Date : January 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Control
Usual care
Behavioral: Usual care
Nephrologists and dialysis facilities will provide usual care regarding access to transplantation.

Experimental: Intervention
Navigator will assist patients in completing steps in transplant process
Behavioral: Transplant navigator
Navigator will provide help to patients in completing specific steps in transplant process.
Other Name: Control: usual care

Primary Outcome Measures :
  1. Number of Steps Completed in Transplant Process [ Time Frame: 18-24 months ]
    Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.

Secondary Outcome Measures :
  1. Impediments to Successful Intervention [ Time Frame: 18-24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-70 years old
  • English speaking
  • Mentally competent

Exclusion Criteria:

  • Prior pre-transplant workup
  • Prior kidney transplant
  • Active systemic infection
  • Active or recent malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00805038

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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Western Reserve University
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Principal Investigator: Ash Sehgal, MD MetroHealth Medical Center
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Responsible Party: Ash Sehgal, MetroHealth Medical Center Identifier: NCT00805038    
Other Study ID Numbers: IRB07-00301
First Posted: December 9, 2008    Key Record Dates
Results First Posted: July 15, 2011
Last Update Posted: July 15, 2011
Last Verified: December 2008
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency