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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Sairam Parthasarathy
Study ID
NCT07799961
Status
Recruiting

Conditions

  • Diabetes Mellitus
  • Hypercholesterolaemia
  • Hypertension
  • Social Determinants of Health (SDOH)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Community Health Worker intervention — OTHER
    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 Care — OTHER
    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 Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Dec 5, 2024
Status verified
Aug 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
740 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Social Care Linkage within an Healthcare System
    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.
  • Active Comparator: Usual Care
    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.

Primary Outcome Measure

Change in Healthcare utilization [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Banner University Medical Center SouthTucsonArizona85713
Kristina M Rico
1(800)970-7118
Sairam Parthasarathy, MD (PRINCIPAL_INVESTIGATOR)
UAHS Center for Sleep, Circadian, & Neuroscience Research Department of Medicine, University of ArizonaTucsonArizona85724
Kristina M Rico
1(800)970-7118
Sairam Parthasarathy, MD (PRINCIPAL_INVESTIGATOR)
Sabrina Oesterle, PhD (SUB_INVESTIGATOR)
Samantha Sabo, DPH, MPH (SUB_INVESTIGATOR)
Jon Tilburt, MD, MPH (SUB_INVESTIGATOR)
Floribella Redondo-Martinez, CCHW, BS (SUB_INVESTIGATOR)

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