Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease

NCT06693661 | Recruiting DMC

• 3 other identifiers: STUDY000079381U01DK1372692025P008750
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Keywords

African American; Health Disparities; Chronic Care Model (CCM); Kidney Health Coach (KHC)

Outcome Measures

Primary Outcomes (2)

• 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

  Throughout study participation up to 12 months

• Time-to-death

  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.

  Throughout study participation up to 12 months

Secondary Outcomes (18)

• Time to progression to end stage kidney disease (ESKD)

  Throughout study participation up to 12 months

• Time-to-optimal Kidney Replacement Therapy (KRT) referral

  Throughout study participation up to 12 months

• Number of participants who transition-to-Kidney Replacement Therapy w/Central Venous Catheter

  Throughout study participation up to 12 months

• Mortality rate

  Throughout study participation up to 12 months

• Nephrology appointment attendance

  Throughout study participation up to 12 months

Study Arms (2)

Intervention: Kidney Health Coaching

OTHER

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

Other: Kidney Health Coaching

Control: Usual Care

OTHER

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

Other: Usual Care

Interventions

Kidney Health Coaching 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.

Also known as: KHC Protocol

Intervention: Kidney Health Coaching

Usual Care 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.

Also known as: Control

Control: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James T. Laney School of Graduate Studies: collaborator
• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kimberly R Jacob Arriola, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly R Jacob Arriola, PhD, MPH

CONTACT

404-727-2600; kjacoba@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Provost for Graduate Studies

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following the completion of the study.
• Access Criteria: Through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Data Repository.

Locations

US (1)