Recruiting

AZCEALLinking Social Care with Healthcare Systems to Address Social Determinants of Health

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Study Aim

This study aims to link social care with healthcare systems to address social determinants of health, observing changes in your healthcare utilization, such as unplanned office visits, urgent care visits, emergency room visits, and hospitalizations.

What is being tested

Community Health Worker Support

+ Standard Healthcare Without CHWs

Other
Who is being recruted

Cardiovascular Diseases+13

+ Endocrine System Diseases

+ Hyperlipidemias

Over 18 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorSairam Parthasarathy
Study ContactKristina RicoMore contacts
Last updated: September 2, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 5, 2024

Actual date on which the first participant was enrolled.

Social drivers of health contribute significantly to disparities in health outcomes for many chronic diseases in low income populations. Social drivers of health and health related social needs exacerbate stress, allostatic load, chronic pain, and cardiovascular outcomes. And in recent years, the consistent and compelling evidence regarding how Social drivers of health influences health has led to growing recognition within healthcare systems of the need to addressing health-related factors upstream of the clinical encounter. Whilst health systems have started collecting patient-level Social drivers of health, most front-line healthcare workers have little time, skill, or resources to address Social drivers of health challenges (Implementation Gap). And, in the health systems we serve, social worker positions employed and embedded within healthcare systems -- the key clinician professional group skilled at addressing SDOH -- are being cut for short term financial performance, leaving vulnerable patient populations disconnected from existing community resources and professional support. Community Health Workers (CHWs) are entry-level paraprofessionals known to provide robust support to link high risk populations with health and social services that could help high risk patient-clients cope with or mitigate the effects of Social drivers of health. Yet, despite their known effectiveness and the prevalent identification of Social drivers of health within healthcare systems, CHWs largely operate outside of healthcare systems and are not effectively linked to those systems in a manner to help patient-clients address identified Social drivers of health challenges and health related social needs. The key research questions that pertain to addressing Social drivers of health elements within healthcare systems are: (a) How to integrate social care (i.e., services that address health-related social risk factors and needs) into clinical practice settings? and (b) what kind of infrastructure is needed to facilitate such activities? To address these important questions, the overarching goal of the Arizona Community Engagement Alliance (AZ-CEAL) will be to disseminate and implement social care integration within healthcare systems by connecting healthcare providers within systems with trained community health workers within the communities while studying process-level (implementation) and client-level (patient outcome) metrics in a stepped wedge design approach within a large statewide healthcare system. This 4-year project proposal will address the overarching overall goal by continuing to leverage our community based participatory research relationship with the Arizona Community Health Worker (AzCHOW) Association representing 1500 CHWs and 200 CHW employers statewide to refine and train CHWs in interventions aimed at addressing Social drivers of health within healthcare delivery settings. We propose an initial planning phase (9 months) that will enable refinement of the evidence-based CHWs and their core competency trainings that are tailored to address care within Arizona healthcare settings and build the linkage infrastructure to connect them with healthcare providers and their patients within healthcare settings. In the implementation phase (39 months), we will undertake a stepped wedge cluster randomized trial to evaluate the process-level (implementation) and client-level (patient outcome) metrics. We will conduct this study within a statewide large healthcare system with 10 clusters per step. We will collect implementation outcomes data consistent with the RE-AIM framework. We will measure effects on process-level outcomes (SDOH elements) measured by patient reports (CEAL Common survey) and healthcare system-data ("No-show" rates) as well as patient-level (client) outcomes (blood pressure, HbA1C, lipid profile, stress, healthcare utilization \[i.e., composite outcome of unplanned office visits, urgent care visits, emergency room visits, and hospitalization\] and even death). The conceptual framework for our proposal is based upon the five activities to better integrate social care into health care delivery that was advocated by the National Academy of Sciences. The activities are to improve awareness, adjustment, assistance, alignment, and advocacy for social care within healthcare systems with multi-level interventions at the community- and systems-level.

NCT07799961
Principal SponsorSairam Parthasarathy
Study ContactKristina RicoMore contacts
Last updated: September 2, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

740 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesEndocrine System DiseasesHyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesDisease AttributesGlucose Metabolism DisordersDyslipidemiasLipid Metabolism DisordersChronic DiseaseDiabetes MellitusHypercholesterolemiaHypertension

Criteria

Inclusion Criteria: * 18 years of age or older * Must meet at least one of the three criteria: * Medicaid or dual-insured beneficiary or * Racial/ethnic minority or rural resident and * Household income in the bottom national quartile of household median income (low SES definition). Exclusion Criteria: * Unable to provide informed consent due to cognitive impairment * Other specified reason that, in the opinion of the investigator makes the participant unsuitable for enrollment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This group connects patients with Community Health Workers (CHWs) who understand local resources. CHWs help patients address social needs related to health, set long-term goals, and create action plans.

Group II

Active Comparator
Participants in this group receive standard care without Community Health Workers (CHWs) addressing social issues and health-related social needs within the healthcare system. Social drivers of health are assessed annually and recorded.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Banner University Medical Center South

Tucson, United StatesOpen Banner University Medical Center South in Google Maps
Recruiting

UAHS Center for Sleep, Circadian, & Neuroscience Research Department of Medicine, University of Arizona

Tucson, United States
Recruiting
2 Study Centers