End-stage Renal DiseaseNCT02389387
Reducing Disparities in Access to Kidney Transplantation (RaDIANT) Regional Study
An observational study of End-stage Renal Disease, run by Emory University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Intensive Intervention
- Type of treatment
- Injection or infusion
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Kidney transplant centers in the geographic area of North Carolina (NC), South Carolina (SC) and Georgia (GA)
- Low rates of referral for kidney transplantation (6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean)
- The presence of a racial disparity (African American vs. Caucasian) in referrals for kidney transplantation (racial disparity calculated based on the crude referral risk difference and the standardized referral risk difference.)
- The final pool of 440 facilities will be randomized to either the intervention or control group using a one to one ratio.
Who cannot join
- Close out date populated
- Transplant and hospital-based facility
- Home dialysis facility
- Patient census <25
- >100 miles from nearest transplant center
- Non-profit facility (except Wake Forest University Dialysis)
About this study
Official title: Reducing Disparities in Access to Kidney Transplantation: The RaDIANT Regional Study
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.
Read the detailed description
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.
- Conditions
- End-stage Renal Disease
- Being tested
- Intensive Intervention
- Keywords
- Dialysis Facilities, African Americans, Racial Disparity, Kidney Transplantation, Community-based Participatory Research, Coalition
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intensive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, one year after completion of the intervention
Secondary outcomes (2)
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.
Measured: Baseline, 6 months after referral, one year after the start of medical evaluation
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.
Measured: Baseline, 6 months after referral, one year after referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Rachel Patzer, Emory University
- Investigators
- Rachel Patzer, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389387
- Sponsor's protocol ID
- IRB00079596
- Other IDs
- 5U01MD010611-05
- Status last verified
- May 2024
- First submitted
- 10 Mar 2015
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39671258
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Access to Kidney Transplantation: The RaDIANT Regional Study
- ClinicalTrials.gov ID
- NCT02389387
- Acronym / sponsor ID
- IRB00079596
- Conditions
- End-stage Renal Disease
- Keywords
- Dialysis Facilities, African Americans, Racial Disparity, Kidney Transplantation, Community-based Participatory Research, Coalition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Mar 2015
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Intensive InterventionTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Kidney transplant centers in the geographic area of North Carolina (NC), South Carolina (SC) and Georgia (GA)
- Low rates of referral for kidney transplantation (6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean)
- The presence of a racial disparity (African American vs. Caucasian) in referrals for kidney transplantation (racial disparity calculated based on the crude referral risk difference and the standardized referral risk difference.)
- The final pool of 440 facilities will be randomized to either the intervention or control group using a one to one ratio.
Key exclusion criteria (6 listed)
- Close out date populated
- Transplant and hospital-based facility
- Home dialysis facility
- Patient census <25
- >100 miles from nearest transplant center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive InterventionI.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. | Other | Intensive Intervention |
Primary outcome
Change in Referral Disparity from baseline
Time frame: Baseline, one year after completion of the intervention
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.
2 secondary outcomes
Change in medical evaluation start racial disparity and waitlisting racial disparity
Time frame: Baseline, 6 months after referral, one year after the start of medical evaluation
Change in number of referrals between Control and Experimental patients from baseline
Time frame: Baseline, 6 months after referral, one year after referral
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 39671258Patzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Patzer, PhD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Referral Disparity from baseline (time frame: Baseline, one year after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.