NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

Not Applicable

Not yet recruiting

• Conditions: Kidney Diseases; Chronic Kidney Diseases

• Registration Number: NCT06810622
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for Latinx with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for Latinx with advanced CKD. The project will have four (4) aims.

Detailed Description

The overarching goal of this project is to eliminate structural racism and reduce kidney health disparities faced by Latinx (gender-inclusive term; includes Hispanics, Latino/a/x) individuals. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for Latinx with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4/5. The investigators hypothesize that compared to standard care, the multilevel NAVIGATE-Kidney intervention will reduce the composite endpoint, defined as (1) time to transition to KRT and central venous catheter use or (2) death (primary outcome), increase the rate of optimal KRT starts and optimal KRT process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for Latinx with advanced CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The investigators will also evaluate Navigate-Kidney implementation outcomes using the PRISM (Practical Robust Implementation and Sustainable Model) science framework and conduct an economic evaluation to inform policy change.

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2025-01-31
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Study Start: 2025-05-30
• Primary Completion: 2027-09-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Adults ≥ 18 years of age,
• Adults who self-identify as Latino/e/a/x and/or Hispanic,
• Adults who are not pregnant,
• Adults who are not incarcerated,
• Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.

Exclusion Criteria

• Anyone who does not meet the criteria outlined above.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)	Composite outcome of time until participants in each arm either 1) begin dialysis (either as first KRT method or as a subsequent preparatory step for transplant) with a central venous catheter (CVC)), or 2) die from all-cause mortality, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)	Rate of participants in each arm that either 1) "crash start" Kidney Replacement Therapy (KRT) via first starting dialysis with a Central Venous Catheter (CVC), or 2) die from all-cause mortality prior to starting any method of KRT, whichever occurs first.
Rate of Participants with Optimal Kidney Replacement Therapy (KRT) Start	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)	Rate of patients with condition: "Optimal KRT start", a composite measure (defined by the CMS Kidney Care Choices (KCC) value-based payment model) that includes patients with any of the following: 1. Pre-emptive kidney transplant; 2. Home dialysis; and/or 3. In-center dialysis start with a functional arteriovenous fistula or graft.
Time to First Optimal Kidney Replacement Therapy (KRT) Process Measure Milestone	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)	Optimal Kidney Replacement Therapy (KRT) start process measure milestones are defined as the following: (1) Endpoints for permanent vascular access: vascular mapping and surgical visit or referral; (2) Endpoints for kidney transplant: Initial transplant visit, undergoing work-up for waitlisting, and waitlisting; (3) Endpoints for home dialysis: Initial evaluation visit for home dialysis.
Change in Estimated Glomerular Filtration Rate eGFR	Screening until End of Study or Death, whichever occurs first (up to 5 years)	Measure of kidney function, reported in mg/dL. Scores of less than 15 may indicate kidney failure, while scores of 90 or higher indicate normal kidney function.
Change in Decisional Conflict Scale (DCS) scores	Baseline, Month 6, Month 12, Month 24	Decisional Conflict Scale (DCS) is a 16-item tool that evaluates patient decisional conflict in 4 domains: informed, clarity, uncertainty, and support. Possible total scores range from 0 to 100, with higher scores indicating higher decisional conflict and worse outcomes.
Change in Patient Activation (PAM-13) scores	Baseline, Month 6, Month 12, Month 24	Patient activation is measured with the Patient Activation Measure 13 (PAM-13), ranging in scores from 0 to 100. Higher scores are associated with improved behaviors related to the patient's self-management of their health and disease, and a better outcome.
Change in Quality of Life, as measured by Patient-Reported Outcomes Measurement Information Systems' (PROMIS) Global Health Scale scores	Baseline, Month 6, Month 12, Month 24	The PROMIS Global Health Scale Version 1.2. is a 10-item tool that evaluates self-reported measures of patients' physical health and function. Possible scores range from 1-10, with higher scores indicating better health and function, and better outcomes.
Change in Social Determinants of Health, as measured by AHC-HRSN Responses	Baseline, Month 6, Month 12, Month 24	The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool is a 10-item, tool that identifies health-related social needs (HRSNs) in patients in 5 domains: Housing Instability, Food Insecurity, Transportation Problems, Interpersonal Safety, and Utility Help needs. Each item is scored using a Yes/No response format. Yes answers indicate a positive screening for a patient need.
Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items)	Baseline, Month 6, Month 12, Month 24	The Rotterdam Renal Replacement Knowledge test (R3K-T) is a 30-item tool that assesses participant knowledge of renal replacement therapy. Possible scores range from 0 to 30, with higher scores indicating more correct answers and higher participant knowledge about therapy.
Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI)	Baseline, Month 6, Month 12, Month 24	The Medical Mistrust Index (MMI) is an 11-item measure that evaluates participants' mistrust of health care organizations. The MMI items are scored on a 4-response Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating more mistrust of healthcare organizations

Trial Locations

Locations (2)

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

University of New Mexico Health Science Center; 🇺🇸 Albuquerque, New Mexico, United States