NAVIGATE-Kidney Program for Kidney Disease

(NAV-Kidney Trial)

Recruiting at 1 trial location

Overseen By Lilia Cervantes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 months

450 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Navigate-Kidney CHW for kidney disease?

Research shows that patient navigator programs and enhanced personal health records can improve healthcare quality for chronic kidney disease (CKD) patients. Additionally, adherence to a multidisciplinary renal health program has been effective in reducing the need for dialysis and lowering mortality rates in CKD patients. ^{1 2 3 4 5}

What safety data exists for the NAVIGATE-Kidney Program for Kidney Disease?

The available research highlights that chronic kidney disease (CKD) patients are at high risk for safety issues, such as medication errors and adverse events, due to impaired kidney function and frequent healthcare interactions. While specific safety data for the NAVIGATE-Kidney Program is not provided, the general safety concerns for CKD patients are well-documented, emphasizing the need for careful monitoring and management to prevent harm. ^{1 6 7 8 9}

How is the NAVIGATE-Kidney CHW treatment different from other kidney disease treatments?

The NAVIGATE-Kidney CHW treatment is unique because it involves patient navigators who help coordinate care, address system barriers, and educate patients, which is not a standard approach in kidney disease management. This program aims to improve outcomes by providing personalized support and education, similar to successful strategies used in cancer care. ^{1 2 10 11 12}

What is the purpose of this trial?

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

Research Team

Lilia Cervantes, MD

Principal Investigator

University of Colorado-Anschutz SOM-Hospital Medicine

Eligibility Criteria

The NAVIGATE Kidney trial is for Latinx individuals with advanced Chronic Kidney Disease (CKD). It aims to improve kidney health outcomes by testing a program called NAVIGATE-Kidney. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions related to CKD.

Inclusion Criteria

Adults who self-identify as Latino/e/a/x and/or Hispanic

I am not pregnant.

I am not currently in prison or jail.

Exclusion Criteria

Anyone who does not meet the criteria outlined above.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NAVIGATE-Kidney intervention with support from a community health worker every 2 weeks for 3 months, followed by monthly visits

3 months

6 visits (in-person) during first 3 months, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of patient-centered outcomes and implementation outcomes

Up to 5 years

Economic Evaluation

Economic evaluation to determine the cost-effectiveness of the NAVIGATE-Kidney intervention

Up to 5 years

Treatment Details

Interventions

• Navigate-Kidney CHW

Trial Overview This study tests the effectiveness of the NAVIGATE-Kidney program compared to standard care in reducing central venous catheter use at kidney replacement therapy start and improving other patient-centered outcomes like activation and decision-making.

Participant Groups

Group I: NAVIGATE-Kidney Control Experimental Treatment 1 Intervention

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.

Group II: NAVIGATE-Kidney CHW Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Findings from Research

Patient navigators can improve certain health outcomes for patients with chronic kidney disease (CKD) and kidney failure, such as enhancing transplant workup and listing, increasing peritoneal dialysis utilization, and boosting patient knowledge, based on a review of 17 studies.

However, many studies had a high risk of bias and did not demonstrate benefits across all outcomes, highlighting the need for more rigorous randomized controlled trials to assess the overall efficacy and cost-effectiveness of navigator programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigators for CKD and Kidney Failure: A Systematic Review. Taha, A., Iman, Y., Hingwala, J., et al.[2022]

A study involving 1486 patients with chronic kidney disease (CKD) showed that participation in CKD care programs led to a slight increase in the overall goal attainment rate from 59.4% to 60.5% over three years, particularly improving management of low-density lipoprotein and glycated hemoglobin levels.

Patients who achieved their treatment goals experienced better preservation of kidney function, as their estimated glomerular filtration rate (eGFR) did not decline, while those with poor goal achievement saw a significant decrease in eGFR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal attainment and renal outcomes in patients enrolled in the chronic kidney disease care program in Taiwan: a 3-year observational study. Wang, Y., Lee, YT., Lee, WC., et al.[2022]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

The National Kidney Foundation's Kidney Early Evaluation Program (KEEP) effectively identifies chronic kidney disease (CKD) in high-risk populations, with 28.7% of the 100,000 participants screened found to have CKD, compared to a lower prevalence of 13.1% reported in the general population.

KEEP's structured screening approach not only detects CKD early but also enhances understanding of kidney disease, supporting public health initiatives aimed at improving outcomes for individuals with diabetes, hypertension, or a family history of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. Vassalotti, JA., Li, S., Chen, SC., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient Navigators for CKD and Kidney Failure: A Systematic Review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Effectiveness of adherence to a renal health program in a health network in Peru. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A crucial lifeline: reducing mortality in the first 120 days. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Goal attainment and renal outcomes in patients enrolled in the chronic kidney disease care program in Taiwan: a 3-year observational study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

9. England pubmed.ncbi.nlm.nih.gov

NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Development of a chronic kidney disease patient navigator program. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Pharmacy program with DM component targets CKD. [2008]