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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| Denver Health and Hospital Authority | OTHER |
| Weill Medical College of Cornell University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigate-Kidney CHW Arm | Experimental | 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. |
|
| Standard Care | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community health worker intervention | Behavioral | Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management. |
| 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) |
| 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) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilia Cervantes, MD | Contact | 3036418009 | lilia.cervantes@cuanschutz.edu | |
| Sandra Hernandez, MPH | Contact | SANDRA.GARCIA-HERNANDEZ@CUANSCHUTZ.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Lilia Cervantes, MD | University of Colorado-Anschutz SOM-Hospital Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Recruiting | Denver | Colorado | 80204 | United States |
Limited data sets will be shared at end of study via an NIDDK registry: NIDDK-CR, in accordance with NIDDK data sharing policies.
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Within 12 months of Primary Completion Date, ongoing.
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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| Standard Care (in control arm) | Behavioral | Participants receive standard care |
|
| 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 |
| 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) |
| University of New Mexico Health Science Center | Not yet recruiting | Albuquerque | New Mexico | 87131 | United States |
|
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |