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

April 14, 2026 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Albert Einstein College of Medicine
        • Principal Investigator:
          • Tanya S Johns, MD, MHS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CHW facilitated social care navigation and peer support as part of IDC

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.
Other: CHOOSE Home Intervention
Integration of a CHW (Community Health Worker) in the CKD (Chronic Kidney Disease) care process to augment patient engagement and address HRSNs (Health-Related Social Needs) within the context of an IDC (Interdisciplinary Care) CKD clinic. The multifaceted components of the intervention are tailored to address key care delivery and social barriers to home dialysis utilization before implementation.
Other Names:
  • CHW Intervention
  • CHW + IDC Intervention
  • IDC + CHW
Other: IDC alone

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.
Other: Usual Care
This is the usual interdisciplinary care that patients would typically receive for their chronic kidney disease. A key missing factor here is the lack of a community health worker. Patients in this group will be screened for health-related social needs and receive general information on ways to access social services from a study coordinator. Patients will not receive facilitated peer support and social care navigation from the Community Health Worker.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selection or Initiation of Home Dialysis
Time Frame: 1 year study follow up period
The percentage of patients who select or initiate home dialysis in each study arm will be summarized by study arm. To account for patients who may not progress to end-stage kidney disease (ESKD) within one year, this percentage will be defined as the sum of non-ESKD patients choosing home dialysis and ESKD patients who start home dialysis, divided by the total patients in each group.
1 year study follow up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported status of Health-related social needs (HRSNs)
Time Frame: From baseline to 6 months and baseline to 1 year

HRSNs will be assessed by the by administration of the Accountable Health Communities Health-Related Social Needs (AHC-HRSN) survey at baseline and 1 year.

The AHC-HRSN is a 26-item screening tool designed to help providers identify patients' needs. This study will focus on five core domains captured in the first 10-items of the screening tool. The five core domains are housing instability, food insecurity, transportation problems, interpersonal safety, and utility help. If a patient answers positively to any domain(s) and desires assistance, they are considered to have that corresponding health-related social need.

Change in HRSN status (i.e., resolved/progress made or no progress) from baseline to 6 months and 1 year will be categorized and summarized by study arm.
From baseline to 6 months and baseline to 1 year
Change in Patient Activation Measure Scores
Time Frame: From baseline to 6 months and baseline to 1 year

Change in Patient Activation Measure (Patient Engagement) will be assessed by assessment of the Patient Activation Measure (PAM) survey at baseline, 6 months, and 1 year.

The PAM is a 13-item survey designed to assess a patient's knowledge, beliefs, confidence, and skills about managing one's healthcare. Each item is scored on a 4-point Likert scale ranging from 1 ("Strongly disagree") to 4 ("Strongly Agree"). Raw scores are transformed to a scale with a theoretical range of 0-100, based on calibration tables, with higher PAM scores indicating higher levels of patient activation.

For purposes of this study, change from baseline to 6 months and 1 year will be assessed, and positive percentage scores will indicate increased patient activation.

The percentage of patients in each arm with a 6-point PAM increase over a period of 6-12 months will be summarized by study arm.
From baseline to 6 months and baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York University

Investigators

  • Principal Investigator: Tanya S Johns, MD, MHS, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-16868
  • 1R01DK140574-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with NIH guidelines, the study team will share data with qualified investigators whose research protocols have been approved by their institutions' Institutional Review Boards. The final dataset will include qualitative and quantitative data including anonymized transcripts, socio-demographics, medical history, social history, and clinical outcomes data. The dataset will be stripped of all personal identifiers according to HIPAA and the Common Rule. The investigator team plans to submit anonymized data to a generalist repository, Vivli, that is participating in the NIH Generalist Repository Ecosystem Initiative (GREI) so that it can be made available to other investigators under an NIH-approved data-sharing agreement that ensures that: (1) data is used only for research purposes and does not identify individual participants; (2) data is handled in a secure and confidential way; and (3) data is destroyed or returned after analyses are completed.

IPD Sharing Time Frame

Following publication, time frame to be determined

IPD Sharing Access Criteria

Data will be shared with qualified research investigators whose research protocols have been approved by their institutions' Institutional Review Boards.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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