End Stage Renal Disease (ESRD)NCT07033117
RaDIANT Health Systems Intervention
A study testing Performance Feedback Reports on Referral and Evaluation Closures, Dialysis Facility Awareness Campaign and Patient Contact via Preferred Method in people with End Stage Renal Disease (ESRD) and Kidney Disease, run by Indiana University at 5 sites in United States.
Trial summary
The overarching goal of the proposed study is to determine whether the addition of structural interventions at the health system level targeting upstream barriers in the transplant process will improve access to transplant evaluation start. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease (ESRD), Kidney Disease
- What is being tested?
- Performance Feedback Reports on Referral and Evaluation Closures, Dialysis Facility Awareness Campaign and Patient Contact via Preferred Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Oct 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Five large transplant centers (Emory Transplant Center and Piedmont Transplant Center in Atlanta, GA; Medical University of SC; Duke University in Durham, NC; and Indiana University in Indianapolis, IN) ~800 referring dialysis center referring to these transplant centers
Who cannot join
- Individuals referred, initiating evaluation, and waitlisted at non-participating start centers
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Piedmont Transplant Institute
Atlanta, Georgia, 30309
Ana Rossi, MD, (404) 605-4600, ana.rossi@piedmont.org
- Recruiting
Emory Transplant Center
Atlanta, Georgia, 30322
Stephen Pastan, MD, (855) 366-7989, stephen.pastan@emoryhealthcare.org
- Recruiting
Duke Transplant Center
Durham, North Carolina, 27710
Goni Katz-Greenberg, MD, (855) 855-6484, goni.katzgreenberg@duke.edu
- Recruiting
IU Health Transplant - Indianapolis
Indianapolis, Indiana, 46202
Jonathan Fridell, MD, (317) 944-4370, jfridell@iu.edu
- Recruiting
MUSC Mid-Carolinas Transplant Center
Lancaster, South Carolina, 29720
Prince Mohan, MD, (843) 792-5097, mohanp@musc.edu
About this study
Official title: The RaDIANT Health Systems Intervention for Improving Access to Kidney Transplantation
The overarching goal of the proposed study is to determine whether the addition of structural interventions at the health system level targeting upstream barriers in the transplant process will improve access to transplant evaluation start.
- Conditions
- End Stage Renal Disease (ESRD), Kidney Disease
- Being tested
- Performance Feedback Reports on Referral and Evaluation Closures, Dialysis Facility Awareness Campaign, Patient Contact via Preferred Method, Phone Call to Dialysis Facility During the Patient's Dialysis Session, Phone Call to Provider
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance Feedback Reports on Referral and Evaluation ClosuresOther
Performance feedback reports will reflect each transplant center's performance related to kidney transplant evaluation initiation and referral closure. These reports aim to help centers understand common reasons why patients do not initiate the evaluation process or failed to proceed beyond the evaluation process, and to identify patterns in referral and evaluation closure practices. Reports will be individualized and distributed quarterly to the transplant center champion by the intervention lead.
Dialysis Facility Awareness CampaignOther
As part of the intervention, dialysis centers will participate in an Awareness Campaign designed to educate staff about transplant center quality improvement efforts and how they may be contacted as part of the project. This campaign may include brief webinars or informative documents distributed via platforms such as IPRO Learn.
Patient Contact via Preferred MethodOther
Transplant centers will contact patients using their preferred method of communication.
Phone Call to Dialysis Facility During the Patient's Dialysis SessionOther
Facilities will enhance their patient communication procedures by making a phone call to the dialysis facility during the patient's dialysis session if the patient has not responded to initial outreach attempts. This additional step increases the likelihood of reaching the patient during a time when they are accessible and can engage in scheduling or follow-up.
Phone Call to ProviderOther
Transplant centers will enhance their outreach procedures by making a phone call to the referring provider (e.g., nephrologist, medical assistant) or another provider involved in the patient's care (e.g., primary care provider) in the event of self-referral if the patient has not responded to initial outreach attempts or "no-shows" an initial evaluation appointment. This additional step ensures that the referring provider is informed of the patient's progress and can assist in re-engagement or decision-making prior to referral closure.
Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-ShowOther
Transplant center staff will utilize transplant referral communication platforms and/or email to communicate updates to dialysis staff regarding patient status (e.g., unable to contact the patient or no-show) before referral closure.
Audit and Tracking of Patient Contact Attempts Prior to Referral ClosureOther
Transplant center staff will continue internally tracking the frequency that a patient is contacted before closure and the date of closure, in alignment with center standard practice. This intervention introduces an audit process to be conducted before closure to ensure that all contact attempts (including one or more attempts to contact the patient directly, one or more phone calls to the alternate preferred contact, or one or more attempted contacts to the dialysis unit to connect with the patient), in alignment with center communication procedures, are appropriately executed.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Component Intervention | Experimental | Five participating transplant centers will multicomponent intervention in their management of patients referred to their transplant center for a kidney transplantation. The intervention will consist of: (1) required performance feedback reports on closed referrals; and a set of optional components that may be implemented variably by centers, including; (2) contacting patients via their preferred method; (3) phone calls to the dialysis facility during the patient's dialysis session; (4) phone calls to the referring or other provider; (5) use of a multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX) or secure email to communicate patient status and no-show information; and (6) communication tracking and audit. Dialysis facilities in GA, NC, SC, and IN will receive resources to support an awareness campaign to support implementation of intervention activities within transplant centers. Receives: Other: Performance Feedback Reports on Referral and Evaluation Closures; Other: Dialysis Facility Awareness Campaign; Other: Patient Contact via Preferred Method; Other: Phone Call to Dialysis Facility During the Patient's Dialysis Session; Other: Phone Call to Provider; Other: Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-Show; Other: Audit and Tracking of Patient Contact Attempts Prior to Referral Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transplant evaluation start within 6 months of transplant referral
The difference in the proportion of patients starting transplant evaluation within 6 months of being referred from baseline to up to one-year post-intervention
Measured: Baseline, Post Intervention (Up to one year)
Secondary outcomes (2)
Change in transplant waitlisting
The difference in the proportion of patients waitlisted from baseline and up to one-year post-intervention
Measured: Baseline, Post Intervention (Up to one year)
Change in transplant receipt among those who were waitlisted
The difference in the proportion of patients who received a transplant among those who were waitlisted from baseline and up to one-year post-intervention
Measured: Baseline, Post Intervention (Up to one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start27 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Indiana University Health, Emory Healthcare, Piedmont Healthcare, Medical University of South Carolina, Duke University
- Responsible party
- Principal investigator, Rachel Patzer, PhD, MPH, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033117
- Sponsor's protocol ID
- 18998 - Aim 2
- Other IDs
- R01DK136283
- Status last verified
- May 2026
- First submitted
- 13 Jun 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RaDIANT Health Systems Intervention for Improving Access to Kidney Transplantation
- ClinicalTrials.gov ID
- NCT07033117
- Acronym / sponsor ID
- 18998 - Aim 2
- Conditions
- End Stage Renal Disease (ESRD), Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Indiana University Health, Emory Healthcare, Piedmont Healthcare, Medical University of South Carolina, Duke University
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- 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 overarching goal of the proposed study is to determine whether the addition of structural interventions at the health system level targeting upstream barriers in the transplant process will improve access to transplant evaluation start.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Component Intervention | Experimental | Other: Performance Feedback Reports on Referral and Evaluation Closures, Other: Dialysis Facility Awareness Campaign, Other: Patient Contact via Preferred Method, Other: Phone Call to Dialysis Facility During the Patient's Dialysis Session, Other: Phone Call to Provider, Other: Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-Show, Other: Audit and Tracking of Patient Contact Attempts Prior to Referral ClosureFive participating transplant centers will multicomponent intervention in their management of patients referred to their transplant center for a kidney transplantation. The intervention will consist of: (1) required performance feedback reports on closed referrals; and a set of optional components that may be implemented variably by centers, including; (2) contacting patients via their preferred method; (3) phone calls to the dialysis facility during the patient's dialysis session; (4) phone calls to the referring or other provider; (5) use of a multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX) or secure email to communicate patient status and no-show information; and (6) communication tracking and audit. Dialysis facilities in GA, NC, SC, and IN will receive resources to support an awareness campaign to support implementation of intervention activities within transplant centers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Five large transplant centers (Emory Transplant Center and Piedmont Transplant Center in Atlanta, GA; Medical University of SC; Duke University in Durham, NC; and Indiana University in Indianapolis, IN) ~800 referring dialysis center referring to these transplant centers
Key exclusion criteria (1 listed)
- Individuals referred, initiating evaluation, and waitlisted at non-participating start centers
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 |
|---|---|---|
| Performance Feedback Reports on Referral and Evaluation ClosuresPerformance feedback reports will reflect each transplant center's performance related to kidney transplant evaluation initiation and referral closure. These reports aim to help centers understand common reasons why patients do not initiate the evaluation process or failed to proceed beyond the evaluation process, and to identify patterns in referral and evaluation closure practices. Reports will be individualized and distributed quarterly to the transplant center champion by the intervention lead. | Other | Multi-Component Intervention |
| Dialysis Facility Awareness CampaignAs part of the intervention, dialysis centers will participate in an Awareness Campaign designed to educate staff about transplant center quality improvement efforts and how they may be contacted as part of the project. This campaign may include brief webinars or informative documents distributed via platforms such as IPRO Learn. | Other | Multi-Component Intervention |
| Patient Contact via Preferred MethodTransplant centers will contact patients using their preferred method of communication. | Other | Multi-Component Intervention |
| Phone Call to Dialysis Facility During the Patient's Dialysis SessionFacilities will enhance their patient communication procedures by making a phone call to the dialysis facility during the patient's dialysis session if the patient has not responded to initial outreach attempts. This additional step increases the likelihood of reaching the patient during a time when they are accessible and can engage in scheduling or follow-up. | Other | Multi-Component Intervention |
| Phone Call to ProviderTransplant centers will enhance their outreach procedures by making a phone call to the referring provider (e.g., nephrologist, medical assistant) or another provider involved in the patient's care (e.g., primary care provider) in the event of self-referral if the patient has not responded to initial outreach attempts or "no-shows" an initial evaluation appointment. This additional step ensures that the referring provider is informed of the patient's progress and can assist in re-engagement or decision-making prior to referral closure. | Other | Multi-Component Intervention |
| Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-ShowTransplant center staff will utilize transplant referral communication platforms and/or email to communicate updates to dialysis staff regarding patient status (e.g., unable to contact the patient or no-show) before referral closure. | Other | Multi-Component Intervention |
| Audit and Tracking of Patient Contact Attempts Prior to Referral ClosureTransplant center staff will continue internally tracking the frequency that a patient is contacted before closure and the date of closure, in alignment with center standard practice. This intervention introduces an audit process to be conducted before closure to ensure that all contact attempts (including one or more attempts to contact the patient directly, one or more phone calls to the alternate preferred contact, or one or more attempted contacts to the dialysis unit to connect with the patient), in alignment with center communication procedures, are appropriately executed. | Other | Multi-Component Intervention |
Primary outcome
Change in transplant evaluation start within 6 months of transplant referral
Time frame: Baseline, Post Intervention (Up to one year)
The difference in the proportion of patients starting transplant evaluation within 6 months of being referred from baseline to up to one-year post-intervention
2 secondary outcomes
Change in transplant waitlisting
Time frame: Baseline, Post Intervention (Up to one year)
Change in transplant receipt among those who were waitlisted
Time frame: Baseline, Post Intervention (Up to one year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance Feedback Reports on Referral and Evaluation Closures, Dialysis Facility Awareness Campaign and Patient Contact via Preferred Method in people with End Stage Renal Disease (ESRD) and Kidney Disease, run by Indiana University at 5 sites in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transplant evaluation start within 6 months of transplant referral (time frame: Baseline, Post Intervention (Up to one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.