Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease

ConditionKidney Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Kidney Health Coaching
Other intervention
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.
Usual Care
Other intervention
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.

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Intervention: Kidney Health CoachingOther 1 intervention

Group B: Control: Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

Time-to-Kidney Replacement Therapy w/Central Venous Catheter

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 frame