NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Community health worker intervention
BehavioralCommunity health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management.
Standard Care (in control arm)
BehavioralParticipants receive standard care
Treatment groups
448 Participants
are divided into 2 treatment groupsGroup A: Navigate-Kidney CHW ArmExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)Secondary outcomes
1
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.
Time frame
From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)2
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.
Time frame
From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)3
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.
Time frame
From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)4
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.
Time frame
Screening until End of Study or Death, whichever occurs first (up to 5 years)Other outcomes
1
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.
Time frame
Baseline up to End of Study (up to 5 Years)2
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.
Time frame
Baseline up to End of Study (up to 5 Years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
University of New Mexico
Collaborator
Denver Health and Hospital Authority
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov