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

Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals 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 individuals with advanced CKD. The project will have four (4) aims.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Community health worker intervention; Behavioral: Standard Care (in control arm)

Detailed Description

The overarching goal of this project is to reduce kidney health disparities faced by individuals with advanced kidney disease. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for individuals with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4. 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 individuals 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 Type: Interventional
• Enrollment (Estimated): 448
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lilia Cervantes, MD; Phone Number: 3036418009; Email: lilia.cervantes@cuanschutz.edu
• Study Contact Backup: Name: Sandra Hernandez, MPH; Email: SANDRA.GARCIA-HERNANDEZ@CUANSCHUTZ.EDU

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health and Hospital Authority
      • Contact: Rocio Pereira, MD; Phone Number: 3034366000; Email: rocio.perieira@dhha.org
      • Principal Investigator: Seth Furgeson, MD
      • Contact: Seth Furgeson, MD; Phone Number: 3037245063; Email: seth.furgeson@dhha.org
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Not yet recruiting
      • University of New Mexico Health Science Center
      • Contact: Mark Unruh, MD; Phone Number: 5052720407; Email: mlunruh@salud.unm.edu
      • Contact: Larissa Myaskovsky, PhD; Phone Number: 5052720070; Email: lmaskovsky@salud.unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥ 18 years of age,
• 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:

• Previous kidney transplant
• Previous surgery for dialysis such as an arteriovenous fistula, arteriovenous graft, or peritoneal dialysis catheter placement
• On chronic dialysis
• Conservative management or primary goal is palliation
• Incarcerated
• Pregnant*
• Under 18 years of age
• Moderate to severe dementia
• Deaf persons
• Lacking health insurance**
• Investigator Discretion: Individuals who, in the judgment of the Site PI (or designee), are deemed unsuitable for participation due to behavioral or logistical circumstances that could compromise study integrity or the safety of the participant or staff.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navigate-Kidney CHW Arm; Arm Description: A CHW will provide support during visits every 2 weeks for 3 months (i.e., 6 visits during first 3 months) followed by monthly visits until 1 year of study participation and then quarterly visits until 2 years of study participation. The CHW Navigate-Kidney intervention includes 4 functions: (1) Build trust through understanding of health experience; (2) Address multilevel social and challenges to facilitate health system navigation; (3) Provide patient-centered education; and (4) Enhance self-management. To provide patient-centered education, the CHW will use a Decision Aid created for this intervention.	Behavioral: Community health worker intervention; Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management.
Active Comparator: Standard Care; Arm Description: Arm Description: Participants will receive standard medical care following diagnosis. This care will include educational materials developed that describe prevention of CKD progression, KRT options, and conservative management in English or Spanish	Behavioral: Standard Care (in control arm); Participants receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death	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.	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death	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.	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
Rate of Participants with Optimal Kidney Replacement Therapy (KRT) Start	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.	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
Time to First Optimal Kidney Replacement Therapy (KRT) Process Measure Milestone	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.	From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
Change in Estimated Glomerular Filtration Rate eGFR	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.	Screening until End of Study or Death, whichever occurs first (up to 5 years)
Change in Decisional Conflict Scale (DCS) scores	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.	Baseline, Month 6, Month 12, Month 24
Change in Patient Activation (PAM-13) scores	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.	Baseline, Month 6, Month 12, Month 24
Change in Quality of Life, as measured by Patient-Reported Outcomes Measurement Information Systems' (PROMIS) Global Health Scale scores	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.	Baseline, Month 6, Month 12, Month 24
Change in Social Determinants of Health, as measured by AHC-HRSN Responses	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.	Baseline, Month 6, Month 12, Month 24
Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items)	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.	Baseline, Month 6, Month 12, Month 24
Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI)	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	Baseline, Month 6, Month 12, Month 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dissemination and implementation RE-AIM outcomes for Navigate-Kidney	PRISM (Practical Robust Implementation and Sustainable Model) contextual factors will be used to assess dissemination and implementation outcomes. PRISM consists of 2 parts: 1) Key contextual factors that impact implementation 2) Implementation outcomes called RE-AIM (Reach-Effectiveness-Adoption-Implementation-Maintenance). Qualitative interviews with community health workers and participants assigned to the NAVIGATE-Kidney intervention arm will be conducted.	Baseline up to End of Study (up to 5 Years)
Economic Evaluation Outcomes	Estimations of the cost of implementing and sustaining the intervention, and analysis to determine the economic value of NAVIGATE-kidney by calculating the incremental cost-effectiveness ratio (ICER) compared to standard care.	Baseline up to End of Study (up to 5 Years)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Weill Medical College of Cornell University; Denver Health and Hospital Authority; University of New Mexico
• Investigators: Principal Investigator: Lilia Cervantes, MD, University of Colorado-Anschutz SOM-Hospital Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): May 15, 2029
• Study Completion (Estimated): May 15, 2029

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dialysis; Transplant; Kidney; Chronic
• Additional Relevant MeSH Terms: Urogenital Diseases; Organizing Pneumonia; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Renal Insufficiency; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Bronchiolitis Obliterans Syndrome; Kidney Diseases; Renal Insufficiency, Chronic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 23-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Limited data sets will be shared at end of study via an NIDDK registry: NIDDK-CR, in accordance with NIDDK data sharing policies.
• IPD Sharing Time Frame: Within 12 months of Primary Completion Date, ongoing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No