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

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.