End Stage Renal Disease
Conditions
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.
Interventions
BEHAVIORALTransplant navigator
Navigator will provide help to patients in completing specific steps in transplant process.
BEHAVIORALUsual care
Nephrologists and dialysis facilities will provide usual care regarding access to transplantation.
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Steps Completed in Transplant Process | 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
| Measure | Time frame |
|---|---|
| Impediments to Successful Intervention | 18-24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care received by participants | 75 |
| Transplant Navigator Navigator will assist patients in completing steps in transplant process | 92 |
| Total | 167 |
Baseline characteristics
| Characteristic | Transplant Navigator | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 18 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 57 Participants | 141 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 9 | 56 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 92 participants | 75 participants | 167 participants |
| Sex: Female, Male Female | 45 Participants | 28 Participants | 73 Participants |
| Sex: Female, Male Male | 47 Participants | 47 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 92 |
| serious Total, serious adverse events | 0 / 75 | 0 / 92 |
Outcome results
Primary
Number of Steps Completed in Transplant Process
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.
Time frame: 18-24 months
Population: ITT analysis. Last observation carried forward for preliminary analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Number of Steps Completed in Transplant Process | 1.0 steps per participant |
| Transplant Navigator | Number of Steps Completed in Transplant Process | 2.8 steps per participant |
Secondary
Impediments to Successful Intervention
Time frame: 18-24 months