Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment

NCT06378476 | Completed

• 1 other identifier: 855188
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Racism, Systemic; Trauma, Psychological

Outcome Measures

Primary Outcomes (1)

• Kidney Disease Quality of Life Instrument (KDQOL)

  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.

  6 months

Secondary Outcomes (3)

• Patient Activation Measure

  6 months

• All-Cause Hospitalizations

  6 months

• Patient preferences for end-stage renal disease treatment

  6 months

Study Arms (3)

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.

Behavioral: IMPaCT Community Health Worker Program; Other: Trauma-Informed Care Training

TIC only

EXPERIMENTAL

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

Other: Trauma-Informed Care Training

Usual Care

NO INTERVENTION

Patients in this arm will receive usual care.

Interventions

Trauma-Informed Care Training OTHER

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

CHW + TIC; TIC only

IMPaCT Community Health Worker Program BEHAVIORAL

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.

CHW + TIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Systemic Racism; Psychological Trauma

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Racism; Prejudice; Social Behavior; Behavior; Social Discrimination; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research coordinators collecting baseline and outcomes data from participants will be blinded to arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sol Katz Professor of Medicine, University of Pennsylvania Perelman School of Medicine; Chief, Division of General Internal Medicine

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: June 17, 2024
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)