Community Health Worker Program for Heart Failure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Henry Ford Health System

Must be taking: Antihypertensives

Must not be taking: Insulin, Anti-diabetics

Disqualifiers: Heart failure, Uncontrolled diabetes, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 2 of the ACHIEVE GREATER Center.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants with certain conditions, like uncontrolled diabetes or severe blood pressure, are excluded, which might imply some medication adjustments could be necessary.

What data supports the effectiveness of the treatment PAL2, PAL2, PAL2 Implementation Intervention (PAL2-II), PHARM-PAL2 for heart failure?

Research shows that community health workers (CHWs) can improve care for heart failure patients by reducing hospital visits and enhancing access to care. CHWs have been effective in managing chronic diseases like hypertension, which is a risk factor for heart problems, suggesting they could also help with heart failure management. ^{1 2 3 4 5}

Is the Community Health Worker Program for Heart Failure safe for humans?

The research does not provide specific safety data for the Community Health Worker Program for Heart Failure, but community health workers have been shown to improve care and health outcomes in various settings, suggesting they are generally safe to work with patients. ^{1 2 5 6 7}

How is the PAL2 treatment for heart failure different from other treatments?

The PAL2 treatment is unique because it involves community health workers (CHWs) who help bridge the gap between underserved communities and the healthcare system, improving access to care and patient outcomes. This approach is different from traditional treatments as it focuses on addressing social determinants of health and enhancing patient support and education. ^{1 2 8 9 10}

Research Team

Eligibility Criteria

This trial is for self-identified Black/African American adults living in the Detroit area with high blood pressure or additional heart failure risk factors. It's not for those with uncontrolled diabetes, resistant hypertension, current pregnancy plans, previous heart failure diagnosis, multiple anti-diabetic drugs use, or extremely high blood pressure.

Inclusion Criteria

I am 18 years old or older.

Self-identified Black/African American

Detroit-area resident (defined as those who attended a Detroit-area community event)

Exclusion Criteria

Self-reported pregnancy (or planning to become pregnant in the next year)

Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)

NTproBNP ≥ 1000 ng/L from SOC screening labs

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive the Pharm-PAL2 intervention via Mobile Health Units to control hypertension and prevent heart failure

12 months

Monthly visits (in-person)

Durability Phase

Continued monitoring and support to maintain intervention effects

12 months

Quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

2 visits (in-person)

Treatment Details

Interventions

• PAL2 (Behavioral Intervention)
• PHARM-PAL2 (N/A)

Trial Overview The ACHIEVE-HF project tests an intervention program called PAL2 delivered by Community Health Workers to reduce health disparities in managing heart failure and high blood pressure among African Americans in Detroit and Cleveland.

Participant Groups

Group I: Intervention Group Experimental Treatment 2 Interventions

PAL2 Intervention Drug Therapy

Group II: Usual Care Group Active Control 1 Intervention

Participants that are randomized into usual care will be assisted with arrangement of follow-up, either with existing primary care provider (PCP) or a Wayne Health provider. All subsequent medical treatment will be at the discretion of the PCP.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

Amanda Bryant-Friedrich

Wayne State University

Chief Executive Officer since 2023

PhD in Pharmaceutical Sciences

Dr. Polsky

Wayne State University

Chief Medical Officer since 2023

MD from Wayne State University

Findings from Research

In a study involving 28 low-socioeconomic, urban patients with heart failure, those who received weekly visits from community health workers (CHWs) after discharge experienced a dramatic 75% reduction in emergency department visits and an 89% reduction in hospital readmissions over 12 months.

The use of CHWs also led to significant decreases in inpatient costs related to heart failure, while control patients receiving usual care showed no significant changes in hospitalizations or costs, suggesting that CHWs can effectively improve health outcomes and reduce healthcare utilization in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers Reduce Rehospitalizations and Emergency Department Visits for Low-Socioeconomic Urban Patients With Heart Failure. Vohra, AS., Chua, RFM., Besser, SA., et al.[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]

The study involving 14 heart failure patients demonstrated that combining a digital monitoring platform with community health worker support was feasible and well-accepted, with 79% of participants expressing willingness to use the intervention again.

Participants engaged actively with the digital tools, using biometric sensors and completing symptom questionnaires regularly, indicating that this approach could help address both clinical and social needs in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Single-Arm Pilot Study. Carter, J., Swack, N., Isselbacher, E., et al.[2023]

A pilot training course for home healthcare workers (HHWs) significantly improved their knowledge of heart failure and caregiving self-efficacy, with participants showing notable gains, especially those who started with lower knowledge levels.

The course was well-received, being deemed engaging and relevant, indicating its potential for broader implementation using a train-the-trainer model to enhance the skills of HHWs across the workforce.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Piloting of a Community-Partnered Heart Failure Training Course for Home Health Care Workers. Sterling, MR., Cho, J., Leung, PB., et al.[2023]

Home care workers (HCWs) identified a strong need for education on heart failure (HF) signs and symptoms, as well as treatment options, highlighting gaps in their current training.

The most concerning symptoms for HCWs included chest pain and shortness of breath, and they expressed difficulty in helping patients adhere to heart-healthy diets, indicating specific areas for targeted educational interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliciting the educational priorities of home care workers caring for adults with heart failure. Leung, PB., Silva, AF., Cho, J., et al.[2023]

References

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

Community Health Workers Reduce Rehospitalizations and Emergency Department Visits for Low-Socioeconomic Urban Patients With Heart Failure. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Single-Arm Pilot Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review of the main mechanisms of heart failure disease management interventions. [2022]

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

Development and Piloting of a Community-Partnered Heart Failure Training Course for Home Health Care Workers. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Eliciting the educational priorities of home care workers caring for adults with heart failure. [2023]

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

Effectiveness of a community health worker cardiovascular risk reduction program in public health and health care settings. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Community Health Workers for CVD Prevention in LMIC. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A mixed methods evaluation of the feasibility, acceptability, and impact of a pilot project ECHO for community health workers (CHWs). [2022]

10. England pubmed.ncbi.nlm.nih.gov

A new resource for developing and strengthening large-scale community health worker programs. [2022]