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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Pilot, pragmatic, randomized, parallel two-arm single site trial
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Albert Einstein College of Medicine
The Bronx, New York 10461
Contact:
Yaxkyn A Mejia, BA
718-430-2064
yaxkyn.mejia@einsteinmed.edu

More Details

Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Yaxkyn A Mejia, BS
718-430-2064
yaxkyn.mejia@einsteinmed.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.