Linking Individual Needs to Community and Clinical Services

NCT03787485 | Completed

• 1 other identifier: 1612044741R001
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Disease

Keywords

Community Health Worker; Community Clinical Linkage

Outcome Measures

Primary Outcomes (4)

• Change from past (three years to baseline) participant glycosylated hemoglobin on the A1c test reported in electronic medical record after initiation of intervention

  Glycosylated hemoglobin (mmol/mol) will be extracted from laboratory reports reported in the electronic medical record.

  July 14, 2014- June 30, 2019

• 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

  Height and weight reported in the participant's electronic medical record will be combined to report BMI in kg/m\^2.

  July 14, 2014- June 30, 2019

• 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

  Systolic and diastolic blood pressure (mmHg) will be extracted from vitals reported in the participant's electronic medical record.

  July 14, 2014- June 30, 2019

• 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

  LDL, HDL, and triglycerides (mg/dL) reported in the participant's electronic medical record will be combined to report total cholesterol (mg/dL).

  July 14, 2014- June 30, 2019

Secondary Outcomes (6)

• 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

  July 14, 2017-March 30, 2019

• Change from baseline in participant physical activity frequency in the last week on 1 question physical activity question at 3 and 6 months

  July 14, 2017-March 30, 2019

• Change from baseline in participant mental and physical health on Short Form 8 Health Assessment (SF8) at 3 and 6 months

  July 14, 2017-September 30, 2019

• 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

  July 14, 2017-September 30, 2019

• Change from baseline in participant hope on the State Hope Scale (SHS) at 3 and 6 months

  July 14, 2017-September 30, 2019

Study Arms (2)

LINKS Participants

Study participants who took part in the LINKS intervention.

Behavioral: LINKS

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.

Interventions

LINKS 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.

LINKS Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participants who do not consent to participate

Sponsors & Collaborators

• Abby Lohr: lead
• Pima County Health Department: collaborator
• Yuma County Health District: collaborator
• El Rio Community Health Center: collaborator
• Sunset Community Health Center: collaborator
• Mariposa Community Health Center: collaborator
• Arizona Community Health Outreach Workers Association (AzCHOW): collaborator

Study Sites (5)

Mariposa Community Health Center

Nogales, Arizona, 85621, United States

Location

El Rio Community Health Center

Tucson, Arizona, 85714, United States

Location

Pima County Health Department

Tucson, Arizona, 85714, United States

Location

Sunset Community Health Center

Yuma, Arizona, 85364, United States

Location

Yuma County Health District

Yuma, Arizona, 85364, United States

Location

Related Publications (4)

• 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.

  PMID: 29363334 BACKGROUND

• 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.

  PMID: 28817321 BACKGROUND

• 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.

  PMID: 28350634 BACKGROUND

• 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.

  PMID: 30975126 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott C Carvajal, PhD, MPH

  University of Arizona Prevention Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Specialist

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 26, 2018
• Study Start: July 14, 2017
• Primary Completion: April 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)