Trauma-Informed Care + Community Health Workers for Chronic Kidney Disease

(SUPPORT Trial)

Overseen By Judith A Long, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Kidney transplant, Dialysis, CHW enrollment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Trauma-Informed Care + Community Health Workers for Chronic Kidney Disease?

Research shows that community health workers (CHWs) help improve health outcomes by providing education and support, especially for underserved populations. They have been effective in managing chronic diseases like asthma, COPD, and heart disease, and have shown promise in improving care for Latinx individuals with kidney disease by building trust and facilitating access to medical care. ^{1 2 3 4 5}

Is the Trauma-Informed Care + Community Health Workers program safe for humans?

Community Health Worker programs, which are part of this treatment, have been shown to improve health outcomes in various settings and are generally considered safe. They help connect people with healthcare services and improve satisfaction with health services, suggesting they are well-received and safe for participants. ^{6 7 8 9 10}

How is the Trauma-Informed Care + Community Health Workers treatment for Chronic Kidney Disease different from other treatments?

This treatment is unique because it involves community health workers (CHWs) who provide culturally informed support and help patients navigate the healthcare system, which can improve access to care and patient self-management, especially in marginalized communities. Unlike traditional medical treatments, this approach focuses on building trust and addressing social and emotional needs alongside medical care. ^{1 10 11 12 13}

Eligibility Criteria

This trial is for Black and Hispanic individuals with stage 4 or 5 chronic kidney disease, who are Medicaid-eligible or uninsured, living in high poverty areas of Philadelphia. It aims to improve care quality by addressing structural racism and psychological trauma.

Inclusion Criteria

I live in a high poverty area in Philadelphia.

I am a patient at a participating clinic.

I am eligible for Medicaid or do not have any health insurance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of support from a community health worker and trauma-informed care training

6 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• IMPaCT Community Health Worker Program
• Trauma-Informed Care Training

Trial Overview The study tests a community health worker program designed to tackle healthcare system biases (IMPaCT) alongside training clinicians in trauma-informed care. Participants will either receive usual care, the CHW intervention plus clinician training, or only clinician training.

Participant Groups

Group I: TIC only Experimental Treatment 1 Intervention

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

Group II: CHW + TIC Experimental Treatment 2 Interventions

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.

Group III: Usual Care Active Control 1 Intervention

Patients in this arm will receive usual care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

In a focus group study with 24 low-income, uninsured adults from Project Access Dallas, participants highlighted that community health workers (CHWs) significantly help them navigate the healthcare system and improve their self-care abilities.

The findings suggest that integrating CHWs into a case management model effectively enhances patient understanding of health issues and supports underserved populations in managing their health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions of a community-based care coordination system. Gimpel, N., Marcee, A., Kennedy, K., et al.[2011]

A community health worker (CHW) intervention was implemented for Latinx individuals at risk for kidney disease, showing that 41% of participants completed the program and 75% of those who engaged scheduled a primary care appointment within 180 days.

Participants reported increased access to healthcare and improved navigation of the medical system, highlighting the intervention's acceptability and potential to address health disparities in kidney care among Latinx communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating Medical Care for Latinx Individuals at Risk for CKD: A Pilot Intervention. Novick, TK., Barrios, F., Osuna, M., et al.[2023]

Community health worker (CHW) interventions have shown promise in improving asthma-related quality of life and control, as well as reducing symptoms in adults, based on a systematic review of 4 studies in the U.S.

There is currently no evidence from the included studies regarding the effectiveness of CHW interventions for chronic obstructive pulmonary disease (COPD), highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the community health worker model in adult asthma and COPD in the U.S.: a systematic review. Parekh, TM., Copeland, CR., Dransfield, MT., et al.[2020]

Community health workers (CHWs) significantly improve care quality and health outcomes for chronic diseases, particularly hypertension, by enhancing access to care and treatment adherence among underserved populations.

CHWs play vital roles in patient education, monitoring health, and facilitating communication between patients and providers, but challenges remain in integrating them into healthcare teams effectively, requiring sustainable funding and policy changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. Brownstein, JN., Bone, LR., Dennison, CR., et al.[2022]

Latinx populations experience higher rates of kidney failure compared to non-Latinx Whites, despite similar rates of chronic kidney disease (CKD), highlighting the need for targeted interventions.

Community health worker (CHW) programs can improve outcomes for Latinx individuals with kidney disease by building trust, allowing participant input, and using trauma-informed approaches, but face challenges like systemic barriers and low recruitment, necessitating further research on their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology. Novick, TK., Cervantes, L., Golestaneh, L., et al.[2023]

To cover the costs of a community health worker (CHW) program that addresses both medical and social needs, each CHW would need to help avoid nearly 50 emergency department visits per year for their caseload of 150 participants.

If participants also avoid 2 hospitalizations, the number of emergency visits needed to offset costs drops to about 34, suggesting that CHW programs can be cost-effective by reducing unnecessary healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where Is the Break-even Point for Community Health Workers? Using National Data and Local Programmatic Costs to Find the Break-even Point for a Metropolitan Community Health Worker Program. Gurley-Calvez, T., Williams, JAR.[2021]

A 15-hour training course significantly improved the asthma medication instruction abilities of 11 immigrant Mexican community health workers (CHWs), with median correct technique scores rising from 25% to 69% for metered dose inhalers and from 0% to 64% for spacers after training.

Post-training evaluations showed that all CHWs demonstrated adequate understanding of medication delivery techniques, indicating that with proper training, CHWs can effectively help families manage asthma medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an asthma medication training program for immigrant Mexican community health workers. Martin, MA., Mosnaim, GS., Rojas, D., et al.[2011]

The community health worker (CHW) program significantly improved patient satisfaction with accessing health services and community resources among 13 patients with type 2 diabetes.

Patients viewed the CHW program positively, indicating it could effectively address their health and social needs in safety net healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. Chang, W., Oo, M., Rojas, A., et al.[2021]

Community health workers (CHWs) have proven to be essential in improving health outcomes globally, particularly in low-income countries where they help reduce childhood undernutrition and improve maternal and child health.

In middle-income countries like Brazil and in the United States, CHWs play a vital role in primary health care and managing chronic diseases, contributing to better health management for populations that are often hard to reach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers in low-, middle-, and high-income countries: an overview of their history, recent evolution, and current effectiveness. Perry, HB., Zulliger, R., Rogers, MM.[2022]

Community health workers (CHWs) play a crucial role in improving the well-being of marginalized communities by providing culturally informed health services that promote equity and healing.

The work of CHWs highlights the importance of addressing systemic oppression in healthcare, advocating for reforms that are informed by both data and the lived experiences of community members, particularly in Latinx and other marginalized populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Community Health Workers' Roles in Latinx Communities Are Essential. Hernandez-Gordon, WD.[2022]

The Northern Manhattan Community Voices Collaborative trained 1,504 community health workers (CHWs) from 2000 to 2005, resulting in a 16%-200% increase in their competency for selected health skills.

These CHWs successfully facilitated health insurance enrollment for approximately 30,000 individuals, helped 8,000 children achieve complete immunization, and supported 4,000 families in managing asthma, demonstrating the effectiveness of integrating CHWs into community health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of community health worker training and programs in NYC. Perez, M., Findley, SE., Mejia, M., et al.[2022]

Community health workers (CHWs) in South Africa face low workplace trust due to poor pay and working conditions, which affects their ability to effectively support marginalized communities dealing with health issues like HIV/AIDS and COVID-19.

Despite having strong interpersonal trust with patients, CHWs struggle to rebuild patients' trust in the health system due to structural challenges like poverty and insensitivity from healthcare providers, highlighting the need for better support and understanding from the health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers' efforts to build health system trust in marginalised communities: a qualitative study from South Africa. Anstey Watkins, J., Griffiths, F., Goudge, J.[2021]

Participants in a community health worker (CHW) diabetes self-management program reported significant improvements in their ability to manage diabetes, including better information access and increased confidence in communicating with healthcare providers.

The program effectively addressed gaps in diabetes care by providing education, motivation, and peer support, which empowered participants to take a more active role in their healthcare and may help reduce racial and ethnic disparities in diabetes outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participants' assessments of the effects of a community health worker intervention on their diabetes self-management and interactions with healthcare providers. Heisler, M., Spencer, M., Forman, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient perceptions of a community-based care coordination system. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Facilitating Medical Care for Latinx Individuals at Risk for CKD: A Pilot Intervention. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Application of the community health worker model in adult asthma and COPD in the U.S.: a systematic review. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Where Is the Break-even Point for Community Health Workers? Using National Data and Local Programmatic Costs to Find the Break-even Point for a Metropolitan Community Health Worker Program. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an asthma medication training program for immigrant Mexican community health workers. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Community health workers in low-, middle-, and high-income countries: an overview of their history, recent evolution, and current effectiveness. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Why Community Health Workers' Roles in Latinx Communities Are Essential. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The impact of community health worker training and programs in NYC. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Community health workers' efforts to build health system trust in marginalised communities: a qualitative study from South Africa. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Participants' assessments of the effects of a community health worker intervention on their diabetes self-management and interactions with healthcare providers. [2022]