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临床试验/NCT06378476
NCT06378476已完成不适用

Using Community Health Workers and Trauma-Informed Care Training for Clinicians to Improve Kidney Disease Outcomes in a Diverse Urban Community

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2024年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
1
主要终点
Kidney Disease Quality of Life Instrument (KDQOL)

研究概览

简要总结

Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences.

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)

盲法说明

Research coordinators collecting baseline and outcomes data from participants will be blinded to arm.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic kidney disease stage 4 or 5
  • Patient at participating general internal medicine or family medicine clinic
  • Medicaid-eligible or uninsured
  • Reside in high poverty Philadelphia zip code

排除标准

  • No history of kidney transplant
  • Not receiving any form of dialysis
  • Not previously enrolled with a community health worker in the past 2 years

研究组 & 干预措施

CHW + TIC

Experimental

Patients in this arm will receive 6 months of support from a community health worker as well as primary care from a clinic where clinicians and staff have undergone trauma-informed care training.

干预措施: IMPaCT Community Health Worker Program (Behavioral)

CHW + TIC

Experimental

Patients in this arm will receive 6 months of support from a community health worker as well as primary care from a clinic where clinicians and staff have undergone trauma-informed care training.

干预措施: Trauma-Informed Care Training (Other)

TIC only

Experimental

Patients in this arm will receive primary care from a clinic where clinicians and staff have undergone trauma-informed care training.

干预措施: Trauma-Informed Care Training (Other)

Usual Care

No Intervention

Patients in this arm will receive usual care.

结局指标

主要结局

Kidney Disease Quality of Life Instrument (KDQOL)

时间窗: 6 months

KDQOL-36 is a short form that includes a generic score (the 12-Item Short Form Health Survey (SF-12), which includes the SF-12 Physical and Mental Component Summaries \[SF-12 PCS and MCS\]) and three CKD-specific subscales: 1) burden of kidney disease, 2) symptoms/problems of kidney disease, and 3) effects of kidney disease. Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, higher scores indicate better health-related quality of life.

次要结局

  • All-Cause Hospitalizations(6 months)
  • Patient Activation Measure(6 months)
  • Patient preferences for end-stage renal disease treatment(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith Long, MD

Sol Katz Professor of Medicine, University of Pennsylvania Perelman School of Medicine; Chief, Division of General Internal Medicine

University of Pennsylvania

研究点 (1)

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