Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease

Official title

Improving Access to Nephrology Treatment and Care Among Patients at Greatest Risk for Kidney Failure

Overview

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

The team aims to implement multi-level, multi-component interventions across primary care and acute care access points and nephrology care, using an experimental 2-group randomized controlled trial, to assess the effectiveness of a kidney health coaching intervention on delaying a) the transition to kidney replacement therapy and central venous catheter use and b) death.

The research team will deliver patient-centered kidney health coaching through full-time kidney health coaches (KHCs), who have lived experience with chronic kidney disease (CKD) and have been selected for certain personality characteristics. The KHCs have undergone training to deliver patient support that aligns with the 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.

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 resour
• 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 p

Primary outcome measures

• Time-to-Kidney Replacement Therapy w/Central Venous Catheter [Time frame: Throughout study participation up to 12 months]
• Time-to-death [Time frame: Throughout study participation up to 12 months]

Secondary outcome measures (12)

• Time to progression to end stage kidney disease (ESKD) [Time frame: Throughout study participation up to 12 months]
• Time-to-optimal Kidney Replacement Therapy (KRT) referral [Time frame: Throughout study participation up to 12 months]
• Number of participants who transition-to-Kidney Replacement Therapy w/Central Venous Catheter [Time frame: Throughout study participation up to 12 months]
• Mortality rate [Time frame: Throughout study participation up to 12 months]
• Nephrology appointment attendance [Time frame: Throughout study participation up to 12 months]
• CKD Symptom Burden [Time frame: Baseline, 6 months and 12 months]
• Quality of Life Scale [Time frame: Baseline, 6 months and 12 months]
• Patient activation Score [Time frame: Baseline, 6 months and 12 months]
• Decisional conflict scale [Time frame: Baseline, 6 months and 12 months]
• Medical Mistrust Organization Score [Time frame: Baseline, 6 months and 12 months]
• Discrimination in Medical Settings (DMS) Scale [Time frame: Baseline, 6 months and 12 months]
• CKD treatment Knowledge [Time frame: Baseline, 6 months and 12 months]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Emory University Hospital Midtown — Atlanta
• Emory Healthcare System — Atlanta

Identifiers

NCT: NCT06693661 · STUDY00007938 · 1U01DK137269 · 2025P008750

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗