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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01MD010611-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to facilitate coordination of transplant centers in North Carolina, South Carolina, and Georgia to share kidney transplant referral data in patients with End-Stage Renal Disease (ESRD) who are candidates for kidney transplantation.
Disparities exist in access to kidney transplantation where poor and minority patients are less likely to access each step of the kidney transplant process. Current national surveillance data does not capture information on transplant referral, and it is unclear to what extent dialysis facility-level factors may influence disparities in access to transplantation. Due to significant variability in the standardized transplant ratios observed at each facility, the investigators hypothesize that there may be facility-related reasons that impact disparities in access to the first step of the kidney transplant process -- referral to the transplant center to undergo an evaluation for the suitability for transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Two hundred twenty (220) dialysis facilities will follow standard of care practices in their management of ESRD patients. They will not receive interventions, but they will have access to standard educational materials and quality improvement through End Stage Renal Disease Network 6. | ||
| Intensive Intervention | Two hundred twenty (220) dialysis facilities will follow standard of care practices and the intensive intervention in their management of ESRD patients. The intensive intervention will consist of 1) A multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX) to enhance coordination between dialysis and transplant staff and track ESRD patients through the seven primary steps to transplant , 2) educational webinars/seminars for staff, 3) facility-specific performance feedback reports, 4) assistance with and review of center-specific action plans to increase transplant referral, 5) scheduled bi-annual phone calls with an SETC member to monitor progress, 6) patient education on transplant via creation of an Education Station in facility lobby, and 7) development of a Peer Mentor program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Intervention | Other | I.A multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX):1) real-time communication between staff across healthcare settings, documenting the use of transplant education materials, 2) sending/receiving electronic referrals for transplant specific to a transplant center's requirements and 3) tracking patients' status in the transplant process (e.g., patient interest in transplant, referral for transplant, evaluation start/completion, waitlist status, and transplant) II. Educational webinars/seminars for staff, III. Facility-specific performance feedback reports, IV. Assistance with and review of center-specific action plans to increase transplant referral, V. Scheduled bi-annual phone calls with an SETC member to monitor progress, VI. Patient education on transplant via creation of an Education Station in facility lobby, VII. Development of a Peer Mentor program. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Referral Disparity from baseline | Assessed by referral disparity ratio: percentage of African American patients over percentage of white patients referred (%AA referred/%white referred) to compare across intervention and control facilities at baseline and one year after completion of the intervention. This is a facility level outcome. | Baseline, one year after completion of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medical evaluation start racial disparity and waitlisting racial disparity | Assessed by the racial disparity ratio (%AA/%white) by facility group (control or experimental) for medical evaluation start within 6 months of referral and placement on the waitlist within 1 year of initiating the medical evaluation. This is a facility level outcome. | Baseline, 6 months after referral, one year after the start of medical evaluation |
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Inclusion Criteria:
The final pool of 440 facilities will be randomized to either the intervention or control group using a one to one ratio.
Exclusion Criteria:
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Research assistants from GA transplant centers will contact ~1500 patients via phone. These are patients that were referred for kidney transplant in 2014 that did and did not start the evaluation process. Verbal consent will be obtained, and then conduct the surveys by phone to ensure that patients with any literacy or visual barriers are included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Patzer, PhD | Emory University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39671258 | Derived | Patzer RE, Buford J, Urbanski M, McPherson L, Paul S, Di M, Harding JL, Katz-Greenberg G, Rossi A, Anand PM, Reeves-Daniel A, Jones H, Mulloy L, Pastan SO; Southeastern Kidney Transplant Coalition. Reducing Disparities in Access to Kidney Transplantation Regional Study: A Randomized Trial in the Southeastern United States. Clin J Am Soc Nephrol. 2025 Feb 1;20(2):256-266. doi: 10.2215/CJN.0000000586. Epub 2024 Dec 13. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2020 | Sep 17, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Change in number of referrals between Control and Experimental patients from baseline | Number of individual-patient referrals within 1 year of dialysis start, medical evaluation start within 6 months among those referred, and waitlisting within 1 year among those who start evaluation, among experimental vs. control patients. | Baseline, 6 months after referral, one year after referral |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |