Community Health Workers for Well-being

Recruiting at 6 trial locations

Overseen By Victor Cueto, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Unable to consent, Prisoners, others

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

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on non-medical issues, so it's unlikely that you will need to change your medication routine.

What data supports the effectiveness of the treatment involving Community Health Workers and Educational Materials?

Research shows that community health workers (CHWs) can improve health outcomes by enhancing access to care and providing culturally sensitive support. A study found that CHWs helped patients get timely follow-up care after hospital discharge and improved communication and mental health, suggesting their effectiveness in supporting well-being. ^{1 2 3 4 5}

Is the use of Community Health Workers generally safe for humans?

The research articles provided do not contain specific safety data about Community Health Workers or Educational Materials as treatments, so there is no relevant safety information available from these sources. ^{6 7 8 9 10}

How is the treatment 'Community Health Workers' different from other treatments for this condition?

Community Health Workers (CHWs) are unique because they are trusted community members who provide informal, community-based health services and create vital links between health providers and the community. Unlike traditional medical treatments, CHWs focus on outreach, health education, and case management, helping to improve access to care and health outcomes, especially for marginalized populations. ^{3 11 12 13 14}

What is the purpose of this trial?

The purpose of the study is learn more about ways to help people with non-medical issues that can affect participant health. The study team will examine if Community Health Workers, members of a community who provide basic health and medical care within communities, are more helpful to people with non-medical issues than simple reading materials on how participants can do it.

Research Team

Olveen Carrasquillo, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals interested in improving their well-being, particularly those facing non-medical issues that impact health. The study seeks participants from communities where health disparities are significant.

Inclusion Criteria

Individuals living within the target community who do not plan to move out of the community within the next six months and have two un-met SDOH needs

I am 50 or older and identify as LGBT.

I am over 21, identify as Black/African American or Hispanic/Non-Hispanic.

Exclusion Criteria

Enrollment in a research study addressing Social Determinants Determinants Of Health (SDOH) in the last three years

Unable or unwilling to consent

Plans to move out of the community during the next six months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are either linked to a community health worker or provided with educational material on Social Determinants of health resources

6 months

Follow-up

Participants are monitored for changes in general well-being, food insecurity, health insurance status, usual source of care, and delayed medical care

6 months

Treatment Details

Interventions

• Community Health Workers
• Educational Materials

Trial Overview The study is testing whether Community Health Workers (CHWs) offering personalized support are more effective at helping with non-medical health-related issues than just providing educational materials to read.

Participant Groups

Group I: Community Health worker Group Experimental Treatment 1 Intervention

Participants in this group will be linked to a community health worker for up to 6 months

Group II: Educational material group Active Control 1 Intervention

Participants in this group will be provided with educational material on Social Determinants of health resources for up to 6 months

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Westat

Collaborator

Trials

49

Recruited

39,700+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The community health worker (CHW) program helped 1600 frequent emergency department users in Buffalo, New York, achieve 43% of their health-related objectives, primarily focused on connecting clients to community resources and primary care.

Success in achieving these objectives was linked to higher client engagement with CHW services, indicating that improving access to resources and addressing systemic barriers could enhance the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers: Addressing Client Objectives Among Frequent Emergency Department Users. Kwan, BM., Rockwood, A., Bandle, B., et al.[2019]

Community health workers play a crucial role in bridging the gap between health providers and the community by offering various services such as health education, outreach, and case management, which enhances access to healthcare.

The study of community health worker programs across seven sites provides valuable insights and lessons that can help improve the effectiveness and implementation of similar programs in other communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community health workers on access, use of services, and patient knowledge and behavior. Zuvekas, A., Nolan, L., Tumaylle, C., et al.[2019]

A tailored community health worker (CHW) intervention significantly improved posthospital outcomes for low-socioeconomic status patients, increasing timely primary care follow-up from 47.9% to 60.0% and enhancing the quality of discharge communication.

The intervention also led to better mental health improvements and patient activation, while reducing the likelihood of multiple 30-day readmissions, indicating that CHWs can effectively address socioeconomic and behavioral factors affecting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. Kangovi, S., Mitra, N., Grande, D., et al.[2018]

The study found that 4.2% of community-dwelling adults reported harmful adverse events in healthcare, primarily due to medication errors (45.5%) and misdiagnosis (25.6%), indicating a need for improved safety measures.

Self-reported harmful events were more common among individuals who had been hospitalized recently and those with lower incomes, suggesting that targeted interventions may be necessary for these vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported adverse events in health care that cause harm: a population-based survey. Adams, RJ., Tucker, G., Price, K., et al.[2020]

In a study involving 1118 patients across 10 community pharmacies, it was found that 58.8% of patients were using both prescription drugs and natural health products (NHPs) concurrently, which significantly increased their risk of experiencing adverse events (AEs).

Patients using both prescription drugs and NHPs were 6.4 times more likely to report an AE compared to those using only prescription drugs, highlighting the importance of monitoring concurrent use for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. Necyk, C., Tsuyuki, RT., Boon, H., et al.[2022]

A consensus workshop with 31 healthcare professionals identified and ranked common adverse events in community care, highlighting the need for better understanding of how these events affect care quality.

The workshop emphasized the importance of further research to establish standardized definitions of adverse events and to prioritize research questions that can improve patient safety in community care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. Masotti, P., Green, M., Shortt, S., et al.[2022]

Community health workers (CHWs) play a crucial role in providing health services and addressing health inequities in marginalized populations, but their contributions in Canada remain largely unrecognized and unregulated.

Research indicates that CHW interventions can effectively reduce health inequities and lower healthcare costs, highlighting the need for better integration of CHWs into the health and social services systems to maximize their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers in Canada and other high-income countries: A scoping review and research gaps. Najafizada, SA., Bourgeault, IL., Labonte, R., et al.[2022]

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) played a crucial role in diabetes self-management by providing encouragement and motivation during 1859 individual patient contacts, which helped patients incorporate diabetes management into their daily lives.

Patients reported that the personal connection and support from CHWs were distinct from that provided by family or healthcare teams, highlighting the importance of integrating CHWs into standard diabetes care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching how, not what: the contributions of community health workers to diabetes self-management. Davis, KL., O'Toole, ML., Brownson, CA., et al.[2018]

References

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

Community Health Workers: Addressing Client Objectives Among Frequent Emergency Department Users. [2019]

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

The Role of Health Informatics in Facilitating Communication Strategies for Community Health Workers in Clinical Settings: A Scoping Review. [2023]

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

Impact of community health workers on access, use of services, and patient knowledge and behavior. [2019]

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

Community Health Workers as a Component of the Health Care Team. [2015]

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

Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

Self-reported adverse events in health care that cause harm: a population-based survey. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

[Adverse events self-declaration system and influenza vaccination coverage of healthcare workers in a tertiary hospital]. [2018]

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

Barriers to healthcare workers reporting adverse events following immunization in Zhejiang province, China. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Community health workers in Canada and other high-income countries: A scoping review and research gaps. [2022]

12. 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]

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

Teaching how, not what: the contributions of community health workers to diabetes self-management. [2018]

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

Community health workers can be a public health force for change in the United States: three actions for a new paradigm. [2021]