Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization- the CHOOSE Home Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Selection or Initiation of Home Dialysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CHOOSE Home Intervention (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.
干预措施: Usual Care (Other)
结局指标
主要结局
Selection or Initiation of Home Dialysis
时间窗: 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.
Selection or Initiation of Home Dialysis
时间窗: 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.
次要结局
- 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)
- 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)