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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether Community Health Workers can better support individuals facing life challenges that impact health compared to simply providing health information to read. Participants will either work with a Community Health Worker or receive educational materials for six months. The trial suits individuals living in the target community who have at least two unmet social needs, such as access to food or housing assistance, and plan to remain in the area for the next six months. As an unphased trial, this study offers a unique opportunity to contribute to innovative community health solutions.

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 prior data suggests that these methods are safe?

Research has shown that community health workers are generally well-accepted because they provide health services and support that respect cultural differences. Although specific studies on safety for this trial are lacking, these workers are trained professionals already active in health-related roles. This suggests they are safe to work with, as they help manage health issues without performing medical procedures. No reports of major problems have been linked to their work in communities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using community health workers because they offer a personalized approach to healthcare by connecting participants directly with someone from their community who understands their needs. This method is different from standard care, which typically relies on healthcare professionals who may not have the same community ties or understanding. The trial aims to see if this personal connection can improve well-being more effectively than just providing educational materials.

What evidence suggests that this trial's treatments could be effective for non-medical issues affecting health?

Research has shown that Community Health Workers (CHWs), one of the treatment options in this trial, effectively help people, especially in underserved communities, improve their health. Studies indicate that involving CHWs often leads to better health outcomes than relying solely on educational materials, the other treatment option in this trial. One study found that CHWs saved about $82 per person annually in healthcare costs. They also improved patients' experiences with care and reduced the need for emergency services. Overall, evidence suggests that CHWs are beneficial in helping people manage their health issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Olveen Carrasquillo, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 and also be offered the opportunity to participate in group level activities

Group II: Educational material group Active Control 1 Intervention

Participants in this group will be provided with educational material on 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+

Published Research Related to This Trial

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) 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 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]

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) 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4781407/

Outcomes of community health worker interventions - PMC We included 53 studies on characteristics and outcomes of CHW interventions, 6 on cost-effectiveness, and 9 on training. CHWs interacted with participants in a ...

2. astho.org astho.org/globalassets/pdf/community-health-workers-summary-evidence.pdf

Community Health Workers: Evidence of Their Effectiveness Interventions by CHWs appear more effective when compared with alternatives and are cost-effective for certain health conditions, particularly among underserved ...

3. hdsbpc.cdc.gov hdsbpc.cdc.gov/s/article/Evidence-of-Impact-for-Community-Health-Workers

Evidence of Impact for Community Health Workers The median change in health care costs after a CHW intervention was a reduction of $82 (range: −$415 to $14) per person per year.9 One well-designed study found ...

4. ahrq.gov ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf

Outcomes of Community Health Worker Interventions To conduct a systematic review of the evidence on characteristics of community health workers (CHWs) and CHW interventions, outcomes of such interventions ...

5. link.springer.com link.springer.com/article/10.1007/s11606-025-09495-6

Effects of a Standardized Community Health Worker ... CHW interventions have been found to improve patients' experience of care, reduce acute care utilization, and promote more equitable health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9162296/

Community health workers: working conditions and ... Community health workers are qualified professionals who provide health services that are culturally appropriate for a region.

7. bls.gov bls.gov/ooh/community-and-social-service/community-health-workers.htm

Community Health Workers They identify health-related issues, collect data, and discuss clients' health concerns within the community. For example, community health workers might ...

8. nnphi.org nnphi.org/learning-opportunities-leading-change-food-safety-and-palliative-care-2/

CHW Personal Safety, Program Evaluation, Health After ... Community health workers and public health workers can learn to be more aware of safety threats and know what strategies will aid in self- ...

9. cdc.gov cdc.gov/niosh/healthcare/about/index.html

About Healthcare Workers Here you can access three dashboards containing charts that use 2019 and 2020 American Community Survey Data. The dashboards provide ...

10. mass.gov mass.gov/community-health-workers

Community Health Workers Information for community health workers, CHW supervisors, CHW employers, and policy makers.