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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Selection or Initiation of Home Dialysis [Срок оценки: 1 year study follow up period]

Вторичные конечные точки (2)

• Change in Patient Activation Measure Scores [Срок оценки: From baseline to 6 months and baseline to 1 year]
• Change in patient-reported status of Health-related social needs (HRSNs) [Срок оценки: From baseline to 6 months and baseline to 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Albert Einstein College of Medicine — The Bronx

Публикации

• 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.
• Francois 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 25506238
• Johns 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. PMID 35479194
• Johns TS, Yee J, Smith-Jules T, Campbell RC, Bauer C. Interdisciplinary care clinics in chronic kidney disease. BMC Nephrol. 2015 Oct 12;16:161. doi: 10.1186/s12882-015-0158-6. PMID 26458811
• Cho EJ, Park HC, Yoon HB, Ju KD, Kim H, Oh YK, Yang J, Hwang YH, Ahn C, Oh KH. Effect of multidisciplinary pre-dialysis education in advanced chronic kidney disease: Propensity score matched cohort analysis. Nephrology (Carlton). 2012 Jul;17(5):472-9. doi: 10.1111/j.1440-1797.2012.01598.x. PMID 22435951
• Hsu HT, Chiang YC, Lai YH, Lin LY, Hsieh HF, Chen JL. Effectiveness of Multidisciplinary Care for Chronic Kidney Disease: A Systematic Review. Worldviews Evid Based Nurs. 2021 Feb;18(1):33-41. doi: 10.1111/wvn.12483. Epub 2020 Nov 28. PMID 33247619
• Peeters 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 24158983
• Manns 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 35314481

Идентификаторы

NCT: NCT06925776 · 2025-16868 · 1R01DK140574-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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