Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment (SUPPORT)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Trauma, Psychological; Racism, Systemic
• Intervention / Treatment: Behavioral: IMPaCT Community Health Worker Program; Other: Trauma-Informed Care Training

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHW + TIC; 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; 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
Experimental: TIC only; 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; 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
No Intervention: Usual Care; Patients in this arm will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preferences for end-stage renal disease treatment	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.	6 months
Patient Activation Measure	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.	6 months
All-Cause Hospitalizations	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.	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Behavior; Social Behavior; Prejudice; Social Discrimination; Racism; Psychological Trauma; Renal Insufficiency, Chronic; Systemic Racism
• Other Study ID Numbers: 855188

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No