Clinical trial NCT06925776: Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Replacement Therapy
Keywords: Community Health Worker
Interdisciplinary Care
Kidney Replacement Therapy
home dialysis
Health-Related Social Needs
patent engagement
Hemodialysis
home hemodialysis
peritoneal dialysis
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-04-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, pragmatic, randomized, parallel two-arm single site trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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 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)
* 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

Primary outcomes:
measure: Selection or Initiation of Home Dialysis
timeFrame: 1 year study follow up period
Secondary outcomes:
measure: Change in Patient Activation Measure Scores
timeFrame: From baseline to 1 year
measure: Change in patient-reported status of Health-related social needs (HRSNs)
timeFrame: From baseline to 1 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Tanya S Johns, MD, MHS
role: PRINCIPAL_INVESTIGATOR
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