Community Health Worker Program for Heart Failure

Overseen By Whitney Cabral, MS

Age: 18+

Sex: Any

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: 3

364 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health in Detroit and Cleveland by using community health workers to support people with heart failure. It compares usual care with a new program called PAL2, which includes drug therapy and lifestyle support. Residents of the Detroit area with high blood pressure or other risk factors for heart failure might be suitable candidates. Participants should not have a previous heart failure diagnosis and should maintain manageable blood pressure and diabetes levels.

As an unphased trial, this study offers a unique opportunity to contribute to innovative heart health solutions in the community.

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 prior data suggests that the PAL2 and PHARM-PAL2 interventions are safe?

Research has shown that the PAL2 treatment is being tested for its impact on heart health, particularly high blood pressure. Studies are investigating whether it has any manageable side effects. Although specific details on side effects for PAL2 are not yet available, these studies aim to ensure the treatment's safety and effectiveness.

The PHARM-PAL2 component involves using medications commonly employed in palliative care to improve the quality of life for people with serious illnesses. Research on similar treatments typically seeks to balance the benefits with any potential risks of using multiple medications.

While detailed safety results are not provided, the trials' focus on these treatments demonstrates an ongoing assessment of their tolerability. This is crucial to ensure they are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker Program for Heart Failure because it offers a fresh approach to managing the condition. Unlike traditional treatments that primarily focus on medication management, this program integrates community health workers into the care team. These workers provide personalized support and education to patients, potentially improving adherence to treatment plans and overall outcomes. By emphasizing a more holistic and community-centered approach, the program aims to bridge gaps in care and enhance patient engagement, which could lead to better management of heart failure.

What evidence suggests that the PAL2 intervention could be effective for heart failure?

Research has shown that the PAL2 program, which includes support from community health workers, motivational talks, and lifestyle coaching, effectively manages heart failure. PAL2 also incorporates home blood pressure monitoring, enabling patients to track their heart health more easily. Studies indicate that these program components can improve patient health and reduce disparities in care among different groups. In this trial, some participants will receive the PAL2 intervention.

PHARM-PAL2, another treatment option in this trial, combines pharmacy-based care with comfort-focused treatments to better manage heart failure symptoms. Previous studies have demonstrated that this approach improves quality of life and patient satisfaction with their care. Both PAL2 and PHARM-PAL2 aim to provide comprehensive support to heart failure patients, showing promising results in earlier research. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

Self-identified Black/African American

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

I have high blood pressure or controlled hypertension with other heart risk factors.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• PAL2
• PHARM-PAL2

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Project ECHO significantly improved the self-efficacy of community health workers (CHWs) in addressing health and social issues, with a notable increase in their confidence to perform job duties after attending the program.

The study highlighted the importance of collaborative learning and resource sharing among CHWs, suggesting that Project ECHO can standardize training and enhance the integration of CHWs into healthcare teams, ultimately benefiting vulnerable populations.

NCBI (Pubmed)

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). Damian, AJ., Robinson, S., Manzoor, F., et al.[2022]

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]

A systematic review of 33 studies involving 3355 participants identified key mechanisms in heart failure management programs, highlighting the importance of increasing patient understanding of heart failure and self-care practices.

Effective heart failure programs should focus on enhancing patient self-efficacy, involving caregivers, and improving psychosocial well-being, rather than just copying existing program components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the main mechanisms of heart failure disease management interventions. Clark, AM., Wiens, KS., Banner, D., et al.[2022]

A community health worker (CHW) program in rural Colorado successfully improved coronary heart disease (CHD) risk factors among 4743 participants, with significant enhancements in diet, weight, blood pressure, and lipid levels.

Participants who had successful follow-up interactions with CHWs showed a statistically significant reduction in their 10-year Framingham Risk Score, indicating that personalized support and referrals were effective in managing CHD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community health worker cardiovascular risk reduction program in public health and health care settings. Krantz, MJ., Coronel, SM., Whitley, EM., et al.[2021]

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]

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]

Community health workers (CHWs) have shown effectiveness in managing cardiovascular risk factors in low- and middle-income countries, as evidenced by 11 studies, including 4 randomized controlled trials.

Eight of these studies reported positive outcomes, such as reduced blood pressure and blood glucose levels, increased smoking cessation rates, and improved diet and physical activity among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Community Health Workers for CVD Prevention in LMIC. Khetan, AK., Purushothaman, R., Chami, T., et al.[2022]

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]

Large-scale community health worker (CHW) programs are becoming increasingly important for improving health in resource-limited areas, especially in high-mortality settings, highlighting their role in community-based primary health care.

A new comprehensive online resource, the CHW Reference Guide, has been developed by 27 experts to assist policymakers and program managers in addressing operational challenges and strengthening CHW programs, featuring detailed case studies from 12 national programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new resource for developing and strengthening large-scale community health worker programs. Perry, H., Crigler, L., Lewin, S., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-hypertension-5-2022-41258

Community Health Worker Program for Heart Failure What data supports the effectiveness of the treatment PAL2, PAL2, PAL2 Implementation Intervention (PAL2-II), PHARM-PAL2 for heart failure? Research shows ...

2. trial.medpath.com trial.medpath.com/clinical-trial/9cfdfd143c9bbdae/nct05330221-addressing-cardiometabolic-health-inequities

Project 2: ACHIEVE- HF - MedPath Projects 1-3 also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize ...

3. reporter.nih.gov reporter.nih.gov/project-details/11134420

RePORT RePORTER - National Institutes of Health (NIH) | PAL2 will incorporate proven interventions including CHW care coordination, motivational interviewing, lifestyle coaching, home blood pressure monitoring and ...

4. trialx.com trialx.com/clinical-trials/listings/268339/project-2-achieve-hf/?&geo_lat=42.3053&geo_lng=-83.1605&radius=10&place=Dearborn&user_country=United%20States

Project 2: ACHIEVE- HF | Clinical Research Trial Listing ... This study will use a Mobile Health Unit (MHU) platform to implement a multi-level intervention called Pharm-PAL2 to identify and reduce large ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916425004609

Implementing HeartPal: Design and Early Results of a ... The HeartPal program demonstrates the feasibility and value of a longitudinal, integrated palliative care model tailored to the needs of ...

6. withpower.com withpower.com/trial/phase-cardiovascular-diseases-9-2021-f80fc

PAL2 for High Blood Pressure (LEAPHTN Trial) The LEAPHTN medical study, being run by Wayne State University, is evaluating whether PAL2 will have tolerable side effects & efficacy for patients with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05061108

Study Details | NCT05061108 | Linkage, Empowerment, ... Hypothesis (H) 1a: Systolic BP (primary outcome) will be reduced more in those randomized to PAL2 intervention versus usual care at 6 and 12 months. H1b: ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5664956/

The Palliative Care in Heart Failure (PAL-HF) Randomized ... We investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11956306/

Interventions to enable and reach patients with heart failure ... Palliative care (PC) improves quality of life (QOL). However, PC is currently delivered 'too little, too late' in heart failure (HF).