Chronic Kidney Diseases, Kidney Diseases
Conditions
Keywords
Kidney, Chronic, Dialysis, Transplant
Brief summary
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.
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.
Interventions
BEHAVIORALCommunity health worker intervention
Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management.
BEHAVIORALStandard Care (in control arm)
Participants receive standard care
Sponsors
University of Colorado, Denver
University of New Mexico
Denver Health and Hospital Authority
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Our clinical trial is a multi-site, unblinded, patient-level randomized controlled trial that will randomize 450 adult Latinx individuals with CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The two arms include: (1) NAVIGATE-Kidney, a CHW Arm, in which 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 end of study or until 3 months following KRT start or (2) a Control (standard care) Arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTLilia Cervantes, MD
CONTACTSandra Hernandez, MPH
PRINCIPAL_INVESTIGATORLilia Cervantes, MD
University of Colorado-Anschutz SOM-Hospital Medicine
Outcome results
None listed