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NCT06925776 | NOT YET RECRUITING | Kidney Replacement Therapy

Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization
Sponsor:

Montefiore Medical Center

Brief Summary:

The goal of this clinical trial is to learn if this intervention (the CHOOSE Home intervention) is feasible and may lead to more home dialysis usage in a high-risk patient population. The main questions it aims to answer are: * Will there be an increase in home dialysis selection or initiation over study follow up? * Will there be a change in patient reported status of Health-Related Social Needs (HRSNs) and patient engagement at 1 year follow up? Researchers will compare the intervention group that will include interdisciplinary care (IDC) and the integration of a Community Health Worker (CHW) into the chronic kidney disease (CKD) care process to the IDC only control group. The research team will assess whether the intervention led to better social care navigation, enhanced patient engagement, and increased home dialysis use.

Condition or disease

Kidney Replacement Therapy

Intervention/treatment

CHOOSE Home Intervention

Usual Care

Phase

NA

Detailed Description:

The overarching aims of the study are to 1) utilize a community- engaged approach with input from diverse community partners to refine the CHOOSE Home Trial; and 2) evaluate the feasibility, acceptability, and possible effect of the CHOOSE Home Intervention. Feasibility and acceptability will be evaluated using complementary quantitative and qualitative measures and organized into the dimensions of the RE-AIM framework. The investigator team hypothesizes that the CHOOSE Home intervention may lead to increased home dialysis utilization by more effectively addressing health-related social needs and fostering greater patient engagement. This proposal brings together experts in CKD care, SDOH, health equity, implementation and community-engaged research. The results will be used to inform further studies in CKD care delivery to reduce health inequities in home dialysis use and improve the quality of life for patients with CKD.

Study Type : INTERVENTIONAL
Estimated Enrollment : 106 participants
Masking : SINGLE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization- the CHOOSE Home Trial
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2027-05-01
Estimated Study Completion Date : 2027-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age ≥ 18 years
  • * Advanced CKD (defined by estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73m2 or less using the 2021 CKD-EPI equation)
  • * English or Spanish speaking
  • * Provide informed consent
  • * Followed by a nephrologist at Montefiore and seen within last 12 months
  • * Willing to receive interdisciplinary care (i.e., nurse practitioner facilitated CKD education and care coordination)
  • * Has at least one unmet social need amenable to CHW intervention
Exclusion Criteria
  • * Active malignancy
  • * Anticipated survival is less than 1 year as determined by the patient's treating nephrologist
  • * Opting to do medical management only (non- dialysis supportive care) for management of their kidney failure
  • * Plan to relocate outside of New York City within the next 12 months
Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization

Location Details

NCT06925776

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New York

Albert Einstein College of Medicine

Bronx, New York, United States, 10461