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

281 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status.

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 data supports the effectiveness of the treatment Special Services in the Community Services for Healthy Living trial?

The effectiveness of community services, similar to Special Services, is supported by research showing improvements in adaptive behaviors and satisfaction among staff and clients when providing intensive community support to people with learning disabilities and challenging behavior. Additionally, programs offering individualized support to older people with ongoing health needs have been shown to improve quality of life and health outcomes. ^{1 2 3 4 5}

Is the Community Services for Healthy Living treatment generally safe for humans?

The research articles provided do not contain specific safety data for the Community Services for Healthy Living treatment or its other names like Special Services. They focus on adverse events in healthcare settings generally, not on this specific treatment. ^{6 7 8 9 10}

How does the treatment 'Special Services' differ from other treatments for this condition?

Special Services is unique because it focuses on community-based support and rehabilitation, which is often not available in remote areas. This approach emphasizes collaboration between local community members and health professionals to help individuals manage their health and maintain independence, unlike traditional treatments that may rely more on clinical settings. ^{11 12 13 14 15}

Research Team

Makenzie Barr-Porter, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Monitoring the outcome of case management and community care: the care programme approach support system (CPASS). [2019]

2. England pubmed.ncbi.nlm.nih.gov

Measuring the quality of service in the community. [2019]

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

Effectiveness of programs that offer individualized, multifactorial support to community-dwelling older people with ongoing health and social care needs: a systematic review protocol. [2023]

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

Providing intensive community support to people with learning disabilities and challenging behaviour: a preliminary analysis of outcomes and costs. [2019]

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

Client outcome reporting: the status method. [2019]

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

Consumers' adverse drug event reporting via community pharmacists: three stakeholder perception. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

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

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

[Adverse drug events in patients hospitalized in internal medicine]. [2013]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. [2019]

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

Implementation and evolution of a regional chronic disease self-management program. [2020]

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

Preventing restrictive placements through community support services. [2011]

13. England pubmed.ncbi.nlm.nih.gov

Developing a community rehabilitation and lifestyle service for a remote indigenous community. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Teamwork for the Mentally Handicapped. [2020]

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

A disability perspective on home care. [2004]