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| ID | Type | Description | Link |
|---|---|---|---|
| 7U01DK127918-02 | U.S. NIH Grant/Contract | View source | |
| IHS-2020C1-19350-IC | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Northwell Health | OTHER |
| Geisinger Clinic | OTHER |
| University of Mississippi Medical Center | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEPS Health System Surveillance and Outreach intervention | Experimental |
| |
| Usual Kidney Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEPS Health System Outreach intervention | Behavioral | STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach |
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| Measure | Description | Time Frame |
|---|---|---|
| Health system reported completion of transplant evaluation | Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Live donor inquires to transplant center | the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire | 6 months, 12 months, 18 months |
| Live kidney donor transplants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebony Boulware, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40199386 | Derived | Boulware LE, Ephraim PL, Shafi T, Green JA, Browne T, Strigo TS, Peskoe S, Wilson J, Lokhnygina Y, Alkon A, Jackson GL, Ellis MJ, Sudan D, Cameron B, Vaitla PK, Cabacungan A, Brubaker L, Obermiller EL, Diamantidis CJ. System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial. Contemp Clin Trials. 2025 Jun;153:107911. doi: 10.1016/j.cct.2025.107911. Epub 2025 Apr 6. |
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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 | Jan 17, 2024 | Jan 27, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| NIH |
| Patient-Centered Outcomes Research Institute | OTHER |
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The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
| 6 months, 12 months, 18 months |
| Placement on deceased kidney donor waitlist | The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS | 6 months, 12 months, 18 months |
| Deceased kidney donor transplants | The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS | 6 months, 12 months, 18 months |
| Health system reported initiation of transplant evaluation | Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports | 18 months |
| Patient reported physician discussions | number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire | baseline, 6 months, 12 months, 18 months |
| Patient reported family discussions | number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire | baseline, 6 months, 12 months, 18 months |
| Patient reported initiation of transplant evaluation | Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire | baseline, 6 months, 12 months, 18 months |
| Patient reported completion of transplant evaluation | Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire | baseline, 6 months, 12 months, 18 months |
| Patient reported identification of a living donor | Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire | baseline, 6 months, 12 months, 18 months |
| Patient reported kidney transplant knowledge | Number of questions patients correctly answer measured by patient report in questionnaire | baseline, 6 months, 12 months, 18 months |
| Patient reported empowerment | Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire. | baseline, 6 months, 12 months, 18 months |
| 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 |