Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Transplant navigator; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Navigator will provide help to patients in completing specific steps in transplant process.; Nephrologists and dialysis facilities will provide usual care regarding access to transplantation.
Other intervention name(s): Control: usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research