Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease (CLARIFy-KD)

Emory University

Status: Not yet enrolling

Conditions: Kidney Diseases

Treatments: Other: Kidney Health Coaching; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06693661

STUDY00007938

1U01DK137269 (U.S. NIH Grant/Contract)

2025P008750 (Other Identifier)

Details and patient eligibility

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.) 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.

Full description

This study has two Aims. In Aim 1, the research team will develop and implement multi-level, multi-component interventions across primary care and acute care access points, nephrology, and dialysis care using the Chronic Care Model as an organizing framework.

Aim 1: Implement multi-level, multi-component interventions across primary care and acute care access points, nephrology, and dialysis care using the Chronic Care Model as an organizing framework. The research team will deliver patient-centered kidney health coaching, with full-time kidney health coaches (KHC). They must have lived experience with chronic kidney disease (CKD) and will be selected for certain personality characteristics. The KHCs will undergo training to deliver patient support that aligns with 4 constructs of the Chronic Care Model: Clinical information systems, Patient self-management, and treatment decision-making support, Delivery system redesign, and Community resources. Participants enrolled in the intervention will receive 6-months of kidney health coaching. Those eligible for participation will be invited to participate and undergo the informed consent process via telephone. Next, study staff will administer the baseline assessment via telephone interview for those who consent.

Aim 2: Using a 2-group randomized controlled trial, determine the effectiveness of the interventions on primary outcomes analyzed at the level of patients (i.e., referral to nephrology and preemptive transplant, uptake of home hemodialysis).

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 University Hospital-Midtown 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Intervention: Kidney Health Coaching

Other group

Description:

Participants will receive patient-centered health coaching delivered by two full-time kidney health coaches for six months.

Treatment:

Other: Kidney Health Coaching

Control: Usual Care

Other group

Description:

Participants will receive the usual care based on where patients are identified (Emergency Room- ER, Primary Care, Hospital Discharge, Primary Care, or Nephrology)

Treatment:

Other: Usual Care