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.
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
- Conditions the study is for
- Social Determinants of Health (SDOH), Hypertension, Diabetes Mellitus
- 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
- 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
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.
- Conditions
- Social Determinants of Health (SDOH), Hypertension, Diabetes Mellitus, Hypercholesterolaemia
- 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 group | Role | What they receive |
|---|---|---|
| Social Care Linkage within an Healthcare System | Experimental | Participants 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 Care | Active comparator | Comparator (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.
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)
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.
- First posted2 Sep 2026
- Study start5 Dec 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of Health (SDOH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sairam Parthasarathy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, Northern Arizona University, Arizona State University, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Sairam Parthasarathy, University of Arizona
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arizona CEAL: Linking Social Care With Healthcare Systems to Address SDOH
- ClinicalTrials.gov ID
- NCT07799961
- Acronym / sponsor ID
- AZCEAL / 2011244240
- Conditions
- Social Determinants of Health (SDOH), Hypertension, Diabetes Mellitus, Hypercholesterolaemia
- Keywords
- community health worker, Social Determinants of Health, Chronic Diseases, Chronic Conditions, CHW, SDOH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Sairam ParthasarathyUniversity, hospital or other
- Collaborators
- University of Arizona, Northern Arizona University, Arizona State University, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Closed Cohort Stepped Wedge Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Social Care Linkage within an Healthcare System | Experimental | Other: Community Health Worker interventionParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareComparator (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Must meet at least one of the three criteria:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker interventionCHWs 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. | Other | Social Care Linkage within an Healthcare System |
| Usual CareParticipants (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. | Other | Usual Care |
Primary outcome
Change in Healthcare utilization
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
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
1 secondary outcome
Change in Patient No-Show Rate
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.