NCT06693661 · Emory University
Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease
(CLARIFy-KD)
What this study is about
Through the use of community-engaged processes, this project seeks to develop and implement clinical decision support (CDS) and a kidney health coaching (KHC) intervention. The CDS seeks to streamline workflows to effectively screen, identify, and link to care for those patients with advanced chronic kidney disease (CKD). The overall project goals are to 1.
View original scientific description
Through the use of community-engaged processes, this project seeks to develop and implement clinical decision support (CDS) and a kidney health coaching (KHC) intervention. The CDS seeks to streamline workflows to effectively screen, identify, and link to care for those patients with advanced chronic kidney disease (CKD). The overall project goals are to 1.) Design and conduct community-engaged clinical trials to test new interventions that dismantle the systemic factors that contribute to kidney health disparities. 2.) Foster research collaborations between investigators, people living with kidney disease, community-based organizations, and other key stakeholders. Researchers aim to assess whether the KHC intervention is effective at delaying the transition to kidney replacement therapy (KRT) and central venous catheter use or death.
Interventions
OTHER
Kidney Health Coaching
The intervention entails support from a KHC that includes: * An initial rapport-building call * Ongoing telephone support at least twice a month for six months * Meeting the patient at all in-person clinic appointments * Documenting interactions in the EMR using a customized platform Telephone support begins with a social determinants of health (SDoH) screening tool to identify barriers and facilitators to CKD self-management and appointment adherence. This tool provides access to local resources based on the patient's ZIP code. Subsequent calls will follow up on resource usage, review CKD educational materials and treatment options, complete the Decision Aid for Renal Therapy tool, and facilitate communication through the patient portal. Each call will start with specific goals (e.g., review National Kidney Foundation CKD materials) and conclude with goals for the next session.
OTHER
Usual Care
ER Discharge (d/c): Participants may receive consultations and support from Care Management in the ER, such as transportation or medication assistance. Follow-up by a social worker varies post-discharge. Hospital d/c: All hospitalized patients are assessed by the care management team to identify psychosocial needs and begin discharge planning, which may include follow-up appointments and resources. High-risk patients receive additional follow-up from a care transitions coordinator for 30 days post-discharge. Primary Care: Patients in primary care clinics have access to various support services. Those recently hospitalized or identified as high-risk receive care coordination from social workers. Internal referrals are managed by referral coordinators, while external referrals come from clinic staff. Discharge information is provided after visits. Nephrology: There are no coordinated support services for chronic kidney disease (CKD) patients receiving nephrology care.
Primary outcome measures
Time-to-Kidney Replacement Therapy w/Central Venous Catheter
Time frame: Throughout study participation up to 12 months
Composite measure of time to transition to Kidney Replacement Therapy (KRT) using a central venous catheter (CVC) over the course of the study period
Time-to-death
Time frame: Throughout study participation up to 12 months
Composite measure of time to death over the course of the study period. A record of death in the electronic medical record (EMR), and the date of death will be recorded. If the data is not available in EMR, national death statistics will be checked, and the patient's family will be asked.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Identifies as African American or Black
- Two estimated glomerular filtration rates (eGFRs) \< 29 separated by at least 90 days but within the past 2 years, or a Kidney Failure Risk Equation (KFRE) score of 10% or greater likelihood of kidney failure within the next 2 years
- Had an encounter at Emory Healthcare through an ambulatory visit or inpatient stay (i.e., ER or hospital visit within the previous 2 months
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
- Currently on dialysis
- currently receiving hospice care or other types of conservative management for terminal illness
- Currently on waitlist, or referred for/or completed a transplant evaluation visit within the past 2 years
- Kidney or another solid organ transplant
- Active cancer treatment
- Non-English speaking
- Participating in another treatment or intervention study at the time of enrollment
- Currently pregnant or planning to become pregnant at the time of recruitment
Where
- Atlanta, Georgia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), James T. Laney School of Graduate Studies
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations