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

ConditionsSocial Determinants of Health (SDOH)Hypertension Diabetes Mellitus Hypercholesterolaemia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSairam Parthasarathy

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

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).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Community Health Worker intervention
Other intervention
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 intervention
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.

Treatment groups

740 Participants

are divided into 2 treatment groups

Group A: Social Care Linkage within an Healthcare SystemExperimental treatment 1 intervention

Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Secondary outcomes

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

Time frame

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

Other outcomes

Change in Social Determinants of Health Risk Burden Assessed Using PRAPARE

Participant-reported social determinants of health will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE). The instrument evaluates social and economic factors potentially affecting health, including housing, transportation, financial strain, employment, education, access to resources, and social support. The outcome will be assessed as the change from baseline in the number of identified social risk factors, with higher counts indicating greater social risk burden.

Time frame

Baseline, 6 months, 12 months, 18 months, and/or end of treatment

Change in Systolic blood pressure

Passively collect systolic blood pressure data from the EMR systems. It will be adjusted for number of anti-hypertensive medications and dosage.

Time frame

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

Change in Diastolic blood pressure

Passively collect diastolic blood pressure data from the EMR systems. It will be adjusted for number of anti-hypertensive medications and dosage.

Time frame

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

Change in HBA1C

Passively collect HBA1C data from the EMR systems. It will be adjusted for number of anti-diabetic medications and dosage.

Time frame

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

Sponsors and contacts

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Sairam Parthasarathy

Lead sponsor

University of Arizona

Sponsor institution

University of Arizona

Collaborator

Northern Arizona University

Collaborator

Arizona State University

Collaborator

Mayo Clinic

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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