Clinical trial NCT06378476: Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment
Official title: Using Community Health Workers and Trauma-Informed Care Training for Clinicians to Improve Kidney Disease Outcomes in a Diverse Urban Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Racism, Systemic
Trauma, Psychological
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Kidney Disease Quality of Life Instrument (KDQOL)
timeFrame: 6 months
Secondary outcomes:
measure: Patient Activation Measure
timeFrame: 6 months
measure: All-Cause Hospitalizations
timeFrame: 6 months
measure: Patient preferences for end-stage renal disease treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
References: