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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve kidney care for Black and Hispanic individuals who face higher risks and barriers in accessing treatment. It tests whether community health workers (local helpers trained to support patients) and trauma-informed care (care that considers past trauma) can enhance the lives of those with chronic kidney disease (CKD). Individuals with stage 4 or 5 CKD living in low-income areas of Philadelphia and who are on Medicaid or uninsured might qualify. The trial will compare usual care to two new approaches, including the IMPaCT Community Health Worker Program, to determine which best enhances quality of life and reduces hospital visits.

As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in kidney care that could benefit the community.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the IMPaCT Community Health Worker Program is well-received by participants. Studies have found that community health workers (CHWs) help patients access necessary healthcare services. For instance, one study found that 69% of participants with abnormal test results sought further medical help with CHW support. This suggests that the program is both safe and effective in aiding patients' healthcare decisions.

In contrast, trauma-informed care (TIC) considers the whole person, including past traumas and current symptoms, aiming to create a safe and supportive environment. Reports have not indicated any negative effects from this method, making it a promising option for managing chronic kidney disease (CKD). Overall, both the CHW program and TIC are considered safe for use in healthcare settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing chronic kidney disease by integrating trauma-informed care with support from community health workers (CHWs). Unlike traditional treatments that focus solely on medical management, this trial emphasizes the holistic support that CHWs can provide, which includes addressing social and emotional factors that may impact a patient's health. The CHW + TIC arm combines this support with trauma-informed care, which trains clinicians to better understand and respond to patients' trauma histories, potentially improving patient engagement and outcomes. This innovative approach aims to enhance the overall care experience, making it more personalized and supportive, which could lead to better management of the condition.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Studies have shown that Community Health Workers (CHWs) can improve health by providing education and support, particularly for underserved groups. In this trial, one arm includes the Penn Medicine IMPaCT CHW program, a proven method that involves local community members in healthcare to remove obstacles and enhance care for marginalized patients. Research indicates that this program can increase understanding of chronic kidney disease (CKD) and improve patients' quality of life. Another arm focuses on Trauma-Informed Care (TIC), which emphasizes understanding and supporting patients who may have experienced trauma, potentially leading to better health outcomes. With TIC, healthcare providers are better prepared to meet their patients' unique needs, potentially reducing hospital visits and increasing patient involvement. Additionally, one arm combines both CHW and TIC interventions to assess their combined impact. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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) 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]

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]

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) 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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925006114

Expanding Kidney Care: How Non-Physician Health ... The current global nephrology workforce is insufficient to meet the rising burden of chronic kidney disease and kidney failure.

2. withpower.com withpower.com/trial/phase-psychological-trauma-5-2024-fa16c

Trauma-Informed Care + Community Health Workers for ... Research shows that community health workers (CHWs) help improve health outcomes by providing education and support, especially for underserved populations.

3. ldi.upenn.edu ldi.upenn.edu/fellows/fellows-resources/apply-for-grants/penn-ldi-research-initiative-on-improving-management-of-chronic-kidney-disease-cycle-2-projects/

LDI Research Initiative on Improving Management of CKD The Penn Medicine IMPaCT Community Health Worker program is a rigorously tested approach to employ invested people from local communities to dismantle ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06925776

Study Details | NCT06925776 | Community Health Workers ... The results will be used to inform further studies in CKD care delivery to reduce health inequities in home dialysis use and improve the quality of life for ...

5. mdpi.com mdpi.com/2076-328X/14/9/750

Patients' Perspectives on the Acceptability and ... This prospective intervention study employed a pre-post quasi-experimental design to evaluate a CHW-led educational program aimed at enhancing CKD knowledge, ...

6. chti.upenn.edu chti.upenn.edu/impact-PCCHW

IMPaCT IMPaCT is an evidence-based, standardized program that harnesses the power of community health workers to improve patient outcomes and quality of care.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06925776

Study Details | NCT06925776 | Community Health Workers ... Patients will receive community health worker (CHW) facilitated social care navigation and peer support around kidney replacement therapy (KRT) decision-making ...

8. kidney.org kidney.org/news-stories/partnering-prevention-addressing-chronic-kidney-disease-risk-agricultural-worker

Addressing Chronic Kidney Disease Risk in Agricultural ... The CDC highlights the positive impact of CHW/P-led interventions on chronic disease management, medication adherence, and access to health care ...