Community Services for Healthy Living

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Makenzie Barr-Porter

Disqualifiers: Pregnancy, Non-English speaking, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if community-focused programs can increase fruit and vegetable consumption and improve food security in Appalachian Kentucky. The study will compare special services (community support programs) in Laurel County with regular extension services in Pike County. It seeks residents of these counties who belong to lower-income, single-parent, or multi-generational households. Participants will complete yearly surveys about their diet and food security. Residents of either county who feel these issues affect their daily lives might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and potentially benefit from enhanced support services.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these community-engaged approaches are safe?

In this study, the "Special Services" treatment aims to improve diet and food security in certain communities. The sources do not directly confirm the safety of these services. However, the study is marked as "Not Applicable" for trial phases, indicating it likely doesn't involve experimental drugs or treatments with unknown risks. Instead, these services probably focus on community involvement and nutrition education, which are generally safe. Without specific information on risks or side effects, it is reasonable to assume the intervention is well-tolerated, as it doesn't include new or untested medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Community Services for Healthy Living" trial because it explores how specialized community services can improve health outcomes in Laurel County compared to standard extension services in Pike County. Unlike traditional health services that often focus on medical treatments, this trial incorporates community-driven support systems, potentially addressing health issues through social and environmental changes. By emphasizing tailored community involvement, this approach could lead to more sustainable and holistic improvements in public health, especially in rural areas with unique challenges. This innovative method seeks to uncover the potential of community resources in enhancing overall well-being, beyond what conventional medical interventions offer.

What evidence suggests that this trial's approaches could be effective for improving fruit and vegetable consumption and food security?

This trial will compare specialized services in Laurel County with standard extension services in Pike County. Research has shown that community health programs, like those under study, often lead to better health outcomes. For example, community health workers (CHWs) can enhance mental health and facilitate easier access to primary care. Studies have found that these programs can reduce hospital readmissions from 40% to 15.2%. They also offer affordable services during public health emergencies. Overall, these programs improve access to health resources and can enhance the health of entire communities. ^{6 7 8 9 10}

Who Is on the Research Team?

Makenzie Barr-Porter, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for residents of Laurel or Pike County who are over 18 years old. It's designed to help improve diet and food security among low-income, single-parent, and multi-generational households. Pregnant individuals, non-English speakers, or those planning to move from the area within three years cannot participate.

Inclusion Criteria

Resident of Laurel of Pike County

I am over 18 years old.

Exclusion Criteria

Pregnancy

Plans to move out of the counties within the next three years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Community-engaged approaches to improve fruit and vegetable consumption and food security status

3 years

Annual data collection

Follow-up

Participants are monitored for changes in dietary quality and food security status

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Special Services

Trial Overview The study is testing if community-driven policy changes and nutrition programs can increase fruit and vegetable consumption in an Appalachian Kentucky community. Participants will receive either standard services or special services involving a Community Advisory Board.

How Is the Trial Designed?

Group I: Laurel County Experimental Treatment 1 Intervention

Specialized services

Group II: Pike County Active Control 1 Intervention

Extension services as usual

Who Is Running the Clinical Trial?

Makenzie Barr-Porter

Lead Sponsor

Trials

1

Recruited

280+

Published Research Related to This Trial

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]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

In a study analyzing 1,567,659 hospital discharges in Spain from 2005-2007, 96,607 adverse drug events (ADEs) were identified, representing 5.55% of all discharges, with a significant portion (82.86%) deemed not preventable.

The study found that adverse drug reactions (ADRs) were more common in women and led to longer hospital stays, highlighting the importance of monitoring and reporting ADEs for improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. Zapatero Gaviria, A., Barba, R., Ruiz Giardin, JM., et al.[2013]

The study revealed that adverse drug event (ADE) reporting is low among consumers and community pharmacists in Thailand, highlighting a need for improved awareness and motivation to report these events.

Key factors influencing ADE reporting included awareness and attitude towards reporting, complications in the reporting process, and the need for better feedback and training for pharmacists, suggesting that targeted interventions could enhance reporting rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumers' adverse drug event reporting via community pharmacists: three stakeholder perception. Kitisopee, T., Assanee, J., Sorofman, BA., et al.[2022]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8410967/

The Effectiveness of Health Services Delivered by ... Studies showed that CHWs contribute to the prevention of mental disorders (11), maternal and child health (12–15), HIV (16), breast cancer (17), diabetes (18), ...

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

Community Health Workers: Evidence of Their Effectiveness Increased likelihood of obtaining primary care, increased mental health improvements, and reduced likelihood of multiple 30-day readmissions from 40% to 15.2%.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11520389/

Enablers and barriers of community health programs for ... CHPs contributed to improved access to health services by providing health services in public health emergencies, affordable and comprehensive ...

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

Outcomes of Community Health Worker Interventions The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care ...

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/counter/pdf/10.1186/s12913-025-12494-2.pdf?utm_source=consensus

Impact of hospital and health system initiatives to address ... Across all outcome measures, 79% demonstrated improvement, with no instances of worsening outcomes. However, 85% of initiatives lacked community ...

6. ors.od.nih.gov ors.od.nih.gov/sr/dohs/safety/laboratory/BioSafety/pages/material_safety_data_main.aspx

Safety Data Sheets - ORS - NIH SDSs are required to provide employees with the information they need to know about the hazards of materials being handled.

7. dph.georgia.gov dph.georgia.gov/

Georgia Department of Public Health GRITS Entry. The Georgia Registry of Immunization Transaction & Services is designed to collect and maintain accurate, complete and current vaccination records.

8. fema.gov fema.gov/pdf/emergency/nrf/nrf-esf-08.pdf

Emergency Support Function #8 – Public Health and ... Public Health and Medical Services includes behavioral health needs consisting of both mental health and substance abuse considerations for incident victims and ...

9. safetyservices.ucdavis.edu safetyservices.ucdavis.edu/units/ehs/research/safety-data-sheets

Safety Data Sheets The purpose of a Safety Data Sheet (SDS), formerly known as Material Safety Data Sheets (MSDS), is to provide information on the hazards of working with a ...

10. mckesson.com mckesson.com/utility/safety-data-sheets/

Safety Data Sheets (SDS) Safety data sheets provide guidelines to help your facility manage safe handling and disposal for drugs, chemicals and other pharmaceutical products.