Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease

NCT ID: NCT06693661

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-06-30

Brief Summary

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.

Detailed 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).

Conditions

Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention: Kidney Health Coaching

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

Group Type: OTHER

Kidney Health Coaching

Intervention Type: OTHER

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.

Control: Usual Care

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

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

KHC Protocol; Control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

James T. Laney School of Graduate Studies

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly R Jacob Arriola

Vice Provost for Graduate Studies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly R Jacob Arriola, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Kimberly R Jacob Arriola, PhD, MPH

Role: CONTACT

kjacoba@emory.edu

404-727-2600

Other Identifiers

1U01DK137269

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P008750

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00007938

Identifier Type: -

Identifier Source: org_study_id