Clinical trial NCT03787485: Linking Individual Needs to Community and Clinical Services
Official title: Linking Individual Needs to Community and Clinical Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Keywords: Community Health Worker
Community Clinical Linkage
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Pima County Health Department
name: Yuma County Health District
name: El Rio Community Health Center
name: Sunset Community Health Center
name: Mariposa Community Health Center
name: Arizona Community Health Outreach Workers Association (AzCHOW)
First posted: 2018-12-26
Enrollment: 189
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be adults (21 and older), among whom approximately 70% are expected to be women, and the majority (at least 60%) to be Hispanic.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from past (three years to baseline) participant glycosylated hemoglobin on the A1c test reported in electronic medical record after initiation of intervention
timeFrame: July 14, 2014- June 30, 2019
measure: Change from past (three years to baseline) participant body mass index (BMI) calculated from height (meters) and weight in (kilograms) reported in electronic medical record after initiation of intervention
timeFrame: July 14, 2014- June 30, 2019
measure: Change from past (three years to baseline) participant blood pressure based on systolic and diastolic blood pressures reported in electronic medical record after initiation of intervention
timeFrame: July 14, 2014- June 30, 2019
measure: Change from past (three years to baseline) participant total cholesterol as measured by low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides reported in electronic medical record after initiation of intervention
timeFrame: July 14, 2014- June 30, 2019
Secondary outcomes:
measure: Change from baseline in participant self-rated health, emotional well-being, and life satisfaction on 3 questions from the Behavioral Risk Factor Surveillance System (BRFSS) at 3 and 6 months
timeFrame: July 14, 2017-March 30, 2019
measure: Change from baseline in participant physical activity frequency in the last week on 1 question physical activity question at 3 and 6 months
timeFrame: July 14, 2017-March 30, 2019
measure: Change from baseline in participant mental and physical health on Short Form 8 Health Assessment (SF8) at 3 and 6 months
timeFrame: July 14, 2017-September 30, 2019
measure: Change from baseline in participant social support on the Social Support Inventory (Enhancing Recovery in Coronary Heart Disease, ENRICHED) (SSI) at 3 and 6 months
timeFrame: July 14, 2017-September 30, 2019
measure: Change from baseline in participant hope on the State Hope Scale (SHS) at 3 and 6 months
timeFrame: July 14, 2017-September 30, 2019
measure: Change from baseline in participant depression on the Center for Epidemiologic Studies Depression Scale (CES-D-R 10) at 3 and 6 months
timeFrame: July 14, 2017-September 30, 2019
Other outcomes:
Locations:
city: Nogales
country: United States
facility: Mariposa Community Health Center
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:
affiliation: University of Arizona Prevention Research Center
name: Scott C Carvajal, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.