Clinical trial NCT04124224: Unidos: Linking Individuals to Social Determinant and Community Health Services
Official title: Unidos: Linking Individuals to Social Determinant and Community Health Services
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Disease
Community Health Workers
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: El Rio Community Health Center
name: Pima County Health Department
name: Yuma County Health District
name: Sunset Community Health Center
name: Maricopa County Health Department
name: Valle del Sol Community Health
name: Mariposa Community Health Center
First posted: 2019-10-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Chronic Disease Risk
timeFrame: 9 months
measure: Social Networks
timeFrame: 6 months
measure: Unidos Implementation within Local Health Departments
timeFrame: 2 months
measure: Social Determinant of Health Factors
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nogales
country: United States
facility: Mariposa Community Health Center
state: Arizona
city: Phoenix
country: United States
facility: Maricopa County Health Department
state: Arizona
city: Phoenix
country: United States
facility: Valle del Sol Community Health
state: Arizona
city: Tucson
country: United States
facility: El Rio Community Health Center
state: Arizona
city: Tucson
country: United States
facility: Pima County Health Department
state: Arizona
city: Yuma
country: United States
facility: Sunset Community Health Center
state: Arizona
city: Yuma
country: United States
facility: Yuma County Health District
state: Arizona
Study officials:
References: