Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment

NCT06378476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Diseases
  • Racism, Systemic
  • Trauma, Psychological

Interventions

BEHAVIORAL

IMPaCT Community Health Worker Program

The IMPaCT intervention consists of three stages: goal-setting, tailored support, and connection with long-term support. CHWs first seek to understand the patient's individual circumstances, life histories, and priorities by using a semi-structured interview guide inquiring about social and behavioral determinants of health. CHWs will then partner with patients to create customized action plans based on patient needs.

OTHER

Trauma-Informed Care Training

Primary care providers and staff at two General Internal Medicine clinics will receive training in providing supportive care to patients who have experienced trauma. The trainings are all action focused and include a review of racism in medicine, understanding intergenerational trauma and its impact on care, naming and mitigating barriers to health equity, and the basics of motivational interviewing

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-11-26
Completion
2025-11-26

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06378476 on ClinicalTrials.gov