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Unidos: Linking Individuals to Social Determinant and Community Health Services

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ClinicalTrials.gov Identifier: NCT04124224
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
El Rio Community Health Center
Pima County Health Department
Yuma County Health District
Sunset Community Health Center
Maricopa County Health Department
Valle del Sol Community Health
Mariposa Community Health Center
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
For 19 years, the Centers for Disease Control and Prevention-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. Our research project, Unidos: Linking Individuals' to Social Determinant and Community Health Services, will result in a model Community-Clinical Linkage intervention to reduce chronic disease risk among Latinos in Arizona. Further, the investigators expect this intervention model to be applicable in other regions and populations. To execute this research, the AzPRC will implement the intervention in partnership with county health departments and Federally Qualified Health Centers. In Unidos the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs.

Condition or disease Intervention/treatment
Chronic Disease Community Health Workers Other: Unidos

Detailed Description:

Latinos in Arizona, who are predominantly of Mexican-origin, are disproportionately affected by chronic disease and social conditions that contribute to health disparities. Important social determinants of health (SDH)--conditions where people live, work, and play--include barriers to healthy food, physical activity, poverty, discrimination, and housing instability as well as insufficient access to quality and culturally-responsive services. Such factors are increasingly recognized within primary care and population health as equal drivers of chronic disease and clinical indicators. Latino health is complex with not only disproportionate barriers, but also health advantages compared to other groups.

Recently, federally qualified health centers (FQHCs) have begun to incorporate assessments of their clients' SDH. With their foci on high-level clinical care for underserved populations, however, the capacity of these entities to respond to social and community needs is markedly limited. Community-clinical linkage (CCL) models provide opportunities for FQHCs to work collaboratively with other entities to leverage extant community resources and capacities. County health departments are uniquely positioned to collaborate with primary care partners and other community agencies to address social determinants.

Existing evidence of the effectiveness of CCLs in improving the health status of Latinos and their antecedent social conditions is scarce. The AzPRC will address this gap by executing a practice-based public health research study within four underserved, predominantly Mexican-origin communities. Our core research project, Unidos: Linking Individuals' to Social Determinant and Community Health Services, will result in a model CCL intervention to reduce chronic disease risk among Latinos in Arizona. Further, the investigators expect this intervention model to be applicable in other regions and populations. To execute this research, the AzPRC will implement the intervention in partnership with county health departments and FQHCs. In Unidos the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs. The aims of this research study are to

  1. Implement and evaluate Unidos, a community-delivered, SDH-focused CHW intervention. The core elements of the evaluation will include community-responsive, mixed methodologies. Our hypothesis is that the Unidos intervention will reduce overall chronic disease risk, defined from the biological component from the American Heart Association's Life's Simple 7. A rigorous quasi-experimental design will be employed to determine Unidos' effect from electronic health records extracted 12 months after enrollment, with comparisons of clients participating vs not participating in the 6-month intervention. Exploratory analyses of cost effectiveness will be executed to further inform the scaling and sustainability of the intervention within local and county health department infrastructures.
  2. To test the sociocultural resilience model of Latino health advantages through the collection and analysis of longitudinal data that includes rich markers of reported health status, health behaviors, and psychosocial factors. The investigators have two hypotheses: a) the CHW-led, culturally embedded, intervention will lead to enhanced social support, social networks, health behaviors, quality of life and general health; and b) social support and social networks will mediate improvements in reported health observed over 6 months.
  3. A secondary aim is to examine whether our novel, CHW-administered assessments, contribute to the understanding of Latino health risk and advantages beyond a self-administered SDH tool that recently became integrated in the electronic health record (EHR) of two of our four clinical partners. The partners' use of this self-administered SDH tool is part of a national effort where select FQHCs across the country are testing whether it has utility for understanding and better addressing the population health needs of the patients they serve.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Unidos: Linking Individuals to Social Determinant and Community Health Services
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Unidos Participants
In the Unidos intervention the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs.
Other: Unidos
The investigators will collaborate with our community partners to implement and evaluate a Community-Clinical Linkage (CCL) model in which Community Health Workers (CHWs) connect individuals to social determinant and community health services and build sociocultural resilience through CHW-facilitated individual and group support. As a public health practice-based study that incorporates evidence-based strategies, the investigators seek to establish Unidos effectiveness in Arizona counties with the highest percentage of Latinos of Mexican origin (Yuma, Pima, Santa Cruz, and Maricopa). Unidos CHWs, based in local health departments, will use evidence-based strategies to address three elements that are important in addressing chronic disease risk: 1) health promotion resources and programs; 2) individual and group-based social support; and 3) leveraging community resources to address social determinants of health.

Non-Unidos Participants: Comparison Group
Using propensity score matching, the investigators will use the medical records of Unidos participants and the electronic health record comparison group to compare health outcomes.



Primary Outcome Measures :
  1. Chronic Disease Risk [ Time Frame: 9 months ]
    Number of Participants with Chronic Disease Risk as Assessed by the American Heart Association Simple 7 (smoking, nutrition, physical activity, weight, blood pressure, cholesterol, and blood sugar) Change from Baseline in Simple 7 score at 3, 6, and 9 months.

  2. Social Networks [ Time Frame: 6 months ]
    Number of Participants with Improved Social Networks as Assessed by the Berkman-Syme Network Index, Change from Baseline to 6 month follow-up.

  3. Unidos Implementation within Local Health Departments [ Time Frame: 2 months ]
    Organizational readiness as assessed through qualitative data collection including focus groups and interviews.

  4. Social Determinant of Health Factors [ Time Frame: 6 months ]
    Number of participants with improved Social Determinant of Health Factors as assessed by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), change from baseline to 6 month follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Arizona counties with significant Latino populations experience underlying social and economic disparities that place them at risk for chronic disease and negative health outcomes. The participating Maricopa, Pima, Yuma, and Santa Cruz counties are where a significant number of the Latino population for the state reside. Compared to the US population, communities in Arizona with a higher percentages of Latinos are more likely to face poverty, be uninsured, and have chronic disease risks.
Criteria

Inclusion Criteria:

  • Adult participants 18 years or older;
  • Adults of Latino origin;
  • Participants who speak either English or Spanish; and
  • Participants who consent to participate in the study.

Exclusion Criteria:

  • Excluded will be participants who do not consent to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124224


Contacts
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Contact: Abby M Lohr, MPH 5206263203 abbylohr@email.arizona.edu
Contact: Maia Ingram, MPH (520) 626-2267 maiai@email.arizona.edu

Locations
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United States, Arizona
Mariposa Community Health Center
Nogales, Arizona, United States, 85621
Maricopa County Health Department Not yet recruiting
Phoenix, Arizona, United States, 85012
Contact: Mark Gallegos       mark.gallegos@maricopa.gov   
Valle del Sol Community Health Not yet recruiting
Phoenix, Arizona, United States, 85014
El Rio Community Health Center
Tucson, Arizona, United States, 85714
Pima County Health Department
Tucson, Arizona, United States, 85714
Sunset Community Health Center
Yuma, Arizona, United States, 85364
Yuma County Health District
Yuma, Arizona, United States, 85364
Sponsors and Collaborators
University of Arizona
El Rio Community Health Center
Pima County Health Department
Yuma County Health District
Sunset Community Health Center
Maricopa County Health Department
Valle del Sol Community Health
Mariposa Community Health Center

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT04124224     History of Changes
Other Study ID Numbers: U48DP006413 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As this is a community-based participatory research study, the investigators will work with our Community Action Board to determine what data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes