Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Racism, Systemic; Trauma, Psychological
• Interventions: Behavioral: IMPaCT Community Health Worker Program; Other: Trauma-Informed Care Training

• Registration Number: NCT06378476
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Study Start: 2024-06-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHW + TIC	IMPaCT Community Health Worker Program	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.
CHW + TIC	Trauma-Informed Care Training	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.
TIC only	Trauma-Informed Care Training	Patients in this arm will receive primary care from a clinic where clinicians and staff have undergone trauma-informed care training.

Primary Outcome Measures

Name	Time	Method
Kidney Disease Quality of Life Instrument (KDQOL)	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.

Secondary Outcome Measures

Name	Time	Method
All-Cause Hospitalizations	6 months	The investigators will ascertain hospitalizations for 6 months after randomization via: a) participant report (with confirmation from a secondary source), b) electronic health records, and c) the Pennsylvania HealthCare Cost Containment Council (PHC4), which captures every hospitalization in the state and has diagnostic codes for hospitalization cause.
Patient Activation Measure	6 months	The 10-item self-reported Patient Activation Measure (PAM) assesses patient knowledge, skill, and confidence for self-management of health conditions. The PAM provides an individual 'activation' score on a 0-100 point scale. Higher scores indicate greater activation.
Patient preferences for end-stage renal disease treatment	6 months	To measure treatment preferences, we will ask patients what treatment they would select today if they needed renal replacement therapy (RRT) now - transplant, in-center dialysis, home dialysis, or palliative care.

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States