Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization
CHOOSE Home
2 other identifiers
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2025
CompletedStudy Start
First participant enrolled
December 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 15, 2026
April 1, 2026
2.4 years
April 7, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Selection or Initiation of Home Dialysis
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 Outcomes (2)
Change in Patient Activation Measure Scores
From baseline to 6 months and baseline to 1 year
Change in patient-reported status of Health-related social needs (HRSNs)
From baseline to 6 months and baseline to 1 year
Study Arms (2)
CHW facilitated social care navigation and peer support as part of IDC
OTHERPatients 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.
IDC alone
OTHERPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Related Publications (17)
United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022.
BACKGROUNDFrancois K, Bargman JM. Evaluating the benefits of home-based peritoneal dialysis. Int J Nephrol Renovasc Dis. 2014 Dec 4;7:447-55. doi: 10.2147/IJNRD.S50527. eCollection 2014.
PMID: 25506238BACKGROUNDJohns TS, Prudhvi K, Motechin RA, Sedaliu K, Estrella MM, Stark A, Bauer C, Golestaneh L, Boulware LE, Melamed ML. Interdisciplinary Care and Preparedness for Kidney Failure Management in a High-Risk Population. Kidney Med. 2022 Mar 17;4(5):100450. doi: 10.1016/j.xkme.2022.100450. eCollection 2022 May.
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PMID: 33247619BACKGROUNDPeeters MJ, van Zuilen AD, van den Brand JA, Bots ML, van Buren M, Ten Dam MA, Kaasjager KA, Ligtenberg G, Sijpkens YW, Sluiter HE, van de Ven PJ, Vervoort G, Vleming LJ, Blankestijn PJ, Wetzels JF. Nurse practitioner care improves renal outcome in patients with CKD. J Am Soc Nephrol. 2014 Feb;25(2):390-8. doi: 10.1681/ASN.2012121222. Epub 2013 Oct 24.
PMID: 24158983BACKGROUNDManns BJ, Garg AX, Sood MM, Ferguson T, Kim SJ, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Dixon SN, Alam A, Allu S, Tangri N. Multifaceted Intervention to Increase the Use of Home Dialysis: A Cluster Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Apr;17(4):535-545. doi: 10.2215/CJN.13191021. Epub 2022 Mar 21.
PMID: 35314481BACKGROUNDMolnar AO, Harvey A, Walsh M, Jain AK, Bosch E, Brimble KS. The WISHED Randomized Controlled Trial: Impact of an Interactive Health Communication Application on Home Dialysis Use in People With Chronic Kidney Disease. Can J Kidney Health Dis. 2021 Jun 4;8:20543581211019631. doi: 10.1177/20543581211019631. eCollection 2021.
PMID: 34158965BACKGROUNDSanders KA, Whited A, Martino S. Motivational interviewing for patients with chronic kidney disease. Semin Dial. 2013 Mar-Apr;26(2):175-9. doi: 10.1111/sdi.12052. Epub 2013 Feb 14.
PMID: 23406198BACKGROUNDLunardi LE, Hill K, Xu Q, Le Leu R, Bennett PN. The effectiveness of patient activation interventions in adults with chronic kidney disease: A systematic review and meta-analysis. Worldviews Evid Based Nurs. 2023 Jun;20(3):238-258. doi: 10.1111/wvn.12634. Epub 2023 Mar 12.
PMID: 36906914BACKGROUNDFiori KP, Rehm CD, Sanderson D, Braganza S, Parsons A, Chodon T, Whiskey R, Bernard P, Rinke ML. Integrating Social Needs Screening and Community Health Workers in Primary Care: The Community Linkage to Care Program. Clin Pediatr (Phila). 2020 Jun;59(6):547-556. doi: 10.1177/0009922820908589. Epub 2020 Mar 5.
PMID: 32131620BACKGROUNDCreswell JW. Qualitative inquiry and research design: Choosing among five approaches, 2nd ed. Thousand Oaks, CA, US: Sage Publications, Inc, 2007.
BACKGROUNDBronfenbrenner U. Toward an experimental ecology of human development. Am Psychol. 1977;32:513-531. doi:10.1037/0003-066X.32.7.513
BACKGROUNDWeinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.
PMID: 3049068BACKGROUNDWeinstein ND, Sandman PM. A model of the precaution adoption process: evidence from home radon testing. Health Psychol. 1992;11(3):170-80. doi: 10.1037//0278-6133.11.3.170.
PMID: 1618171BACKGROUNDGlasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
PMID: 30984733BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya S Johns, MD, MHS
Albert Einstein College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2025
First Posted
April 13, 2025
Study Start
December 12, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Following publication, time frame to be determined
- Access Criteria
- Data will be shared with qualified research investigators whose research protocols have been approved by their institutions' Institutional Review Boards.
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.