Linking Individual Needs to Community and Clinical Services

NCT ID: NCT03787485

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-14

Study Completion Date

2019-09-30

Brief Summary

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For 15 years, the Centers for Disease Control and Prevention (CDC)-funded Arizona Prevention Research Center (AzPRC) has been engaged in academic community collaborative research to reduce chronic disease health disparities among the Latino border communities in Arizona, which positions the center well to contribute to CDC's current winnable battle of nutrition, physical activity and obesity. The AzPRC's research study Linking Individual Needs to Community and Clinical Services (LINKS) will implement and evaluate a CHW-delivered preventive program linking primary care settings dedicated to reaching the under-served with community services that are county-delivered or -based. By developing community-clinical linkages, the AzPRC will help ensure access to, and quality of, culturally relevant prevention and promotion efforts. These efforts will result in a sustainable and scalable CHW model program that reduces obesity and associated chronic disease, and improves overall health in under-served communities at the Arizona U.S.-Mexico border.

Detailed Description

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Over the past 15 years, CDC-funded AzPRC researchers have strengthened collaborations with community partners while developing and implementing comprehensive diabetes prevention and control programs (1998-2019), and policy intervention research (2009-2014) in Southern Arizona border communities. The community health worker (CHW)-led diabetes programs were successful in terms of community perception and health improvements. Despite this success, disparities in chronic disease remained unacceptably high. The investigators developed and implemented an innovative intervention research project, Acción Para La Salud (Acción), which engaged CHWs in community-level advocacy to empower border communities to address root causes of chronic disease. This community-based participatory research (CBPR) project recognized the importance of addressing the social determinants of health to overcome health disparities in chronic disease. The investigators have published results and processes of Acción.

Chronic disease and obesity health disparities continue to disproportionately affect Hispanic populations along the U.S. Mexico border in part due to barriers to healthful nutrition, adequate physical activity, and mental/emotional well-being as well as insufficient access to culturally appropriate health care services. In collaboration with our border-wide Community Action Board (CAB), the investigators are taking our intervention expertise one step further by developing and testing novel CHW-led interventions that will link community and clinical services.

In recent years, federally qualified community health centers (FQHCs), a major backbone of the primary care system in reaching under-served populations across the US, have begun to involve the CHW model into various services, often with a focus on chronic disease prevention and control. While CHWs help improve the quality and cultural relevancy of health care, improve patient centered care, and improve linkages between primary care and community services, each clinic adapts practices within their clinic environment without clear guidelines about best practices, or concrete evidence regarding activities best shown to lead to improvement in health outcomes. In addition, there may not be clear linkages from the clinic to CHW programs in the community that have been shown to be effective in chronic disease control and prevention, and there are challenges in identifying mechanisms for the sustainability of effective clinical or community programs. Our intervention research proposes to fill these gaps by establishing clear guidance and best practices for CHW involvement in primary care and community settings to prevent and manage chronic disease, and to promote mental/emotional well-being.

Conditions

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Chronic Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LINKS Participants

Study participants who took part in the LINKS intervention.

LINKS

Intervention Type BEHAVIORAL

The primary aim of LINKS is to create community-clinical linkages between three community health centers and their respective county health departments in southern Arizona. This study will also develop and evaluate a chronic disease and emotional well-being intervention that will connect clinic patients to community-centered, county-delivered, community health worker programs.

Electronic Medical Record Controls

The principal analytical strategy is propensity score matching, which will lead to the generation of a natural control group from the health centers existing electronic medical records. Propensity matching is highly effective in addressing selection bias of known confounders and enables causal inferences when randomization is not possible, feasible or appropriate, by creating matched groups with similar covariate distributions. Matched controls will be extracted from the electronic medical record from the participating clinics.

No interventions assigned to this group

Interventions

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LINKS

The primary aim of LINKS is to create community-clinical linkages between three community health centers and their respective county health departments in southern Arizona. This study will also develop and evaluate a chronic disease and emotional well-being intervention that will connect clinic patients to community-centered, county-delivered, community health worker programs.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants who have pre-diabetes, glucose intolerance or diabetes, and/or hypertension, and/or high cholesterol
* Participants not receiving palliative care;
* Participants without a history of serious mental illness (SMI)
* Participants who are not pregnant;
* Participants who speak either English or Spanish;
* Participants who are geographically close to the community based site; and
* Participants who consent to participate in the study.

Exclusion Criteria

* Participants who do not consent to participate
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pima County Health Department

UNKNOWN

Sponsor Role collaborator

Yuma County Health District

UNKNOWN

Sponsor Role collaborator

El Rio Community Health Center

OTHER

Sponsor Role collaborator

Sunset Community Health Center

UNKNOWN

Sponsor Role collaborator

Mariposa Community Health Center

UNKNOWN

Sponsor Role collaborator

Arizona Community Health Outreach Workers Association (AzCHOW)

UNKNOWN

Sponsor Role collaborator

Abby Lohr

OTHER

Sponsor Role lead

Responsible Party

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Abby Lohr

Senior Research Specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Scott C Carvajal, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Prevention Research Center

Locations

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Mariposa Community Health Center

Nogales, Arizona, United States

Site Status

El Rio Community Health Center

Tucson, Arizona, United States

Site Status

Pima County Health Department

Tucson, Arizona, United States

Site Status

Sunset Community Health Center

Yuma, Arizona, United States

Site Status

Yuma County Health District

Yuma, Arizona, United States

Site Status

Countries

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United States

References

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Lohr AM, Ingram M, Nunez AV, Reinschmidt KM, Carvajal SC. Community-Clinical Linkages With Community Health Workers in the United States: A Scoping Review. Health Promot Pract. 2018 May;19(3):349-360. doi: 10.1177/1524839918754868. Epub 2018 Jan 24.

Reference Type BACKGROUND
PMID: 29363334 (View on PubMed)

Ingram M, Doubleday K, Bell ML, Lohr A, Murrieta L, Velasco M, Blackburn J, Sabo S, Guernsey de Zapien J, Carvajal SC. Community Health Worker Impact on Chronic Disease Outcomes Within Primary Care Examined Using Electronic Health Records. Am J Public Health. 2017 Oct;107(10):1668-1674. doi: 10.2105/AJPH.2017.303934. Epub 2017 Aug 17.

Reference Type BACKGROUND
PMID: 28817321 (View on PubMed)

Reinschmidt KM, Ingram M, Morales S, Sabo SJ, Blackburn J, Murrieta L, David C, Carvajal SC. Documenting Community Health Worker Roles in Primary Care: Contributions to Evidence-Based Integration Into Health Care Teams, 2015. J Ambul Care Manage. 2017 Oct/Dec;40(4):305-315. doi: 10.1097/JAC.0000000000000178.

Reference Type BACKGROUND
PMID: 28350634 (View on PubMed)

Lohr AM, Ingram M, Carvajal SC, Doubleday K, Aceves B, Espinoza C, Redondo F, Coronado G, David C, Bell ML. Protocol for LINKS (linking individual needs to community and clinical services): a prospective matched observational study of a community health worker community clinical linkage intervention on the U.S.-Mexico border. BMC Public Health. 2019 Apr 11;19(1):399. doi: 10.1186/s12889-019-6725-1.

Reference Type DERIVED
PMID: 30975126 (View on PubMed)

Other Identifiers

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1612044741R001

Identifier Type: -

Identifier Source: org_study_id

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