Clinical trial NCT06693661: Collaborating Leaders to Address Racism With Interventions for Equity: Kidney Disease
Official title: Mitigating the Effects of Structural Racism on Chronic Kidney Disease Disparities Among African Americans
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Kidney Diseases
Keywords: African American
Health Disparities
Chronic Care Model (CCM)
Kidney Health Coach (KHC)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: James T. Laney School of Graduate Studies
First posted: 2024-11-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Through the use of community-engaged processes and an anti-racism approach, 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 effects of structural racism 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 that target patient-and provider-level outcomes across primary care and acute care access points, nephrology, and dialysis care, using the Chronic Care Model (CCM) and Public Health Critical Race Praxis (PHCRP) as organizing frameworks.

Aim 1: Implement multi-level, multi-component interventions across primary care, acute care access points, nephrology, and dialysis care using the Chronic Care Model (CCM) and PHCRP as organizing frameworks. 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: Conduct a 2-group, single-blinded randomized design-controlled trial to determine the effectiveness of the intervention on primary and secondary outcomes measured via patient self-report and the electronic medical record.

Eligibility criteria: Inclusion Criteria:

* Identifies as African American or Black;
* Age 18 and over;
* 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

Primary outcomes:
measure: Time of disease progression to intervention
timeFrame: Throughout study participation up to 12 months
Secondary outcomes:
measure: Time to progression to end stage kidney disease (ESKD)
timeFrame: Throughout study participation up to 12 months
measure: Number of referrals for optimal KRT start
timeFrame: Throughout study participation up to 12 months
measure: Number of participants who transition to KRT and CVC use or death
timeFrame: Throughout study participation up to 12 months
measure: Proportion of appointments attended
timeFrame: Throughout study participation up to 12 months
measure: CKD Symptom Burden Scale
timeFrame: Baseline, 6 months and 12 months
measure: Quality of Life Scale
timeFrame: Baseline, 6 months and 12 months
measure: Patient activation Score
timeFrame: Baseline, 6 months and 12 months
measure: Decisional conflict scale
timeFrame: Baseline, 6 months and 12 months
measure: Medical mistrust organization score.
timeFrame: Baseline, 6 months and 12 months
measure: CKD treatment Knowledge
timeFrame: Baseline, 6 months and 12 months
measure: Kidney replacement therapy (KRT) Knowledge Score
timeFrame: Baseline, 6 months and 12 months
measure: Shared Decision-Making Score
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
measure: Number of participants that experienced healthcare discrimination
timeFrame: Baseline, 6 months and 12 months
measure: Social Risk Score
timeFrame: Baseline, 6 months and 12 months
measure: Mental Health Score
timeFrame: Baseline, 6 months and 12 months
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Kimberly R Jacob Arriola, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: