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NCT Number: NCT06925776

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

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.

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Key information

Conditions

Kidney Replacement Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location status: Recruiting

Location contact

Tanya S Johns, MD, MHS

PRINCIPAL_INVESTIGATOR

Yaxkyn A Mejia, BA

CONTACT

[email protected]

718-430-2064

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHOOSE Home Intervention

Other

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

Usual Care

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yaxkyn A Mejia, BS

CONTACT

[email protected]

718-430-2064

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

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

Registry information

Official study 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

Acronym: CHOOSE Home

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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