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

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Kidney Replacement Therapy

Treatments: Other: Usual Care; Other: CHOOSE Home Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06925776

1R01DK140574-01 (U.S. NIH Grant/Contract)

2025-16868

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Chronic Kidney Disease Epidemiology Collaboration (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)

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

CHW facilitated social care navigation and peer support as part of IDC

Other group

Description:

Patients will receive community health worker (CHW) facilitated social care navigation and peer support around kidney replacement therapy (KRT) decision-making as part of their interdisciplinary care (IDC) for CKD, up to 1 year. Participants will complete surveys, questionnaires, or interviews at baseline, 6 months, and 12 months.

Treatment:

Other: CHOOSE Home Intervention

IDC alone

Other group

Description:

Patients will receive IDC (Interdisciplinary Care) only. They will not receive CHW (Community Health Worker) facilitated peer support and social care navigation. Participants will complete surveys, questionnaires, or interviews at baseline, 6 months, and 12 months.

Treatment:

Other: Usual Care