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Social Determinants of Health (SDOH)AZCEALNCT07799961

Arizona CEAL: Linking Social Care With Healthcare Systems to Address SDOH

A study testing Community Health Worker intervention in people with Social Determinants of Health (SDOH) and Hypertension, run by Sairam Parthasarathy at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of the Arizona Community Engagement Alliance (AZ-CEAL) will be to combine social care with healthcare programs. The study will be connecting selected patients from clinics with trained community health workers (CHW) who will assist participants in getting the help that is needed for their health such as… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Community Health Worker intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
2 sitesUnited States
Study dates
5 Dec 2024to 1 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Banner University Medical Center South

    Tucson, Arizona, 85713

    Kristina M Rico, 1(800)970-7118 ext. 101, UAHS-AZCEAL@arizona.edu

    Sairam Parthasarathy, MD

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

    Tucson, Arizona, 85724

    Kristina M Rico, 1(800)970-7118 ext. 101, UAHS-AZCEAL@arizona.edu

    Sairam Parthasarathy, MD

    Recruiting

Other trials in United States

About this study

The goal of the Arizona Community Engagement Alliance (AZ-CEAL) will be to combine social care with healthcare programs. The study will be connecting selected patients from clinics with trained community health workers (CHW) who will assist participants in getting the help that is needed for their health such as transportation needs, accessing healthy food, health information, accessing good health care, job opportunities, and housing. The study will collect information from both the patients and the health care systems to test how effectively the care plan works over time.

Read the detailed description

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.

Being tested
Community Health Worker intervention, Usual Care
Keywords
community health worker, Social Determinants of Health, Chronic Diseases, Chronic Conditions, CHW, SDOH
Medical subject headings
Hypertension, Diabetes Mellitus, Hypercholesterolemia, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Health Worker interventionOther

    CHWs with knowledge of local community resources will address social needs through through a IVR platform. Both CHWs and participants can access each other through the IVR system. Patients are observed repeatedly so that measurements are nested within members. We will recruit participants into the closed cohort prior to the sequential roll-out of the intervention to ensure individual-level informed consent and patient-reported data. Recruiting individuals before the intervention is rolled into the clinic (cluster) enables both concurrent comparisons of participants receiving care across clinics as well as pre-post comparisons of individual level (patient-reported) data in addition to passive data collection at a system or clinic level. Primary Data collected through patient reported surveys and passive EMR collection will occur at baseline and 6 months. Patients may opt-in to additional data collection at 12, 18, 24, 36 month time points.

  • Usual CareOther

    Participants (patients) do not have CHWs addressing social issues and HRSNs within the healthcare system. The healthcare personnel act upon the identified social issues independently or with assistance from local clinic resources as usual. The social drivers of health are assessed by phone interview as part of annual population health assessments and entered into the Electronic Medical Records system and that in turn informs the healthcare provider.

Study groups in NCT07799961
Study groupRoleWhat they receive
Social Care Linkage within an Healthcare SystemExperimentalParticipants will be assigned to CHWs with knowledge of the local community resources based upon participant's residential area. The CHWs will assist the patient participant by systematically assessing and addressing the social drivers of health and Health Related Social Needs (HRSNs). A standardized assessment tool will be implemented to systematically identify baseline drivers of health. The CHWs will set long term goals and create an action plan with the patient. Through CHW core competencies of coaching, advocacy, and individual capacity building, the CHWs will use an adapted Goal Setting and Action Planning tool to prioritize short and long term goals to ensure patient self-sufficiency, self-determination and ensure patient navigation and mediation are people-centered.
Receives: Other: Community Health Worker intervention
Usual CareActive comparatorComparator (Description of usual care): Participants receiving care in clinics at the same time of a stepped-wedge design in a different clinic cluster but before the rolling in of the CHW-intervention described in the active comparator. These participants (patients) do not have CHWs addressing social issues and HRSNs within the healthcare system. The social drivers of health are assessed by phone interview as part of annual population health assessments and entered into the Electronic Medical Records system.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Healthcare utilization

    Composite outcome of unplanned office visits, urgent care visits, emergency room visits, and hospitalizations. Data is passively collected through the EMR system. The data is expressed as a rate (events/year) that is calculated from 6 months of data

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

Secondary outcomes (1)
  1. Change in Patient No-Show Rate

    Missed clinic appointment (numerator) compared to total clinic appointments (denominator). Data is passively collected through the EMR system. This is calculated as a rate (No-shows/year) from 6-months of data

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start5 Dec 2024
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Closed Cohort Stepped Wedge Cluster Randomized Trial
Masking
None (open label)
Enrolment
740 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799961
Sponsor's protocol ID
2011244240
Other IDs
OT2HL158287
Acronym
AZCEAL
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Community Health Worker intervention in people with Social Determinants of Health (SDOH) and Hypertension, run by Sairam Parthasarathy at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristina Rico (1(800)970-7118 ext. 101, UAHS-AZCEAL@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Healthcare utilization (time frame: Baseline, 6 months, 12 months, 18 months, and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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