An interventional study of WE CARE SDOH System and Standard Pediatric Care in Hyperlipidemias, Diabetes and Depression, sponsored by University of Massachusetts, Worcester. Recruiting at 3 sites in United States. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Screening
The goal of this clinical trial is to learn if the implementation of the WE CARE social determinants of health (SDOH) screening and referral intervention with an antiracist lens in primary care settings can lead to a meaningful decrease in chronic disease by monitoring conditions such as hypertension, diabetes, depression, hyperlipidemia, and asthma through clinical measures. The main question it aims to answer is:
Does the WE CARE SDOH screening and referral intervention applying an antiracism lens informed implementation strategies have the potential to reduce racial/ethnic health inequities in chronic diseases for minoritized patients?
With a multidisciplinary team of social determinants of health (SDOH), implementation, antiracism, community-engaged, and practice-based researchers, the investigators will apply an antiracism framework to an existing evidence-based SDOH screening and referral system and develop a holistic implementation toolkit aimed at reducing bias and mitigating unequal treatment for families of color. The investigators will first conduct qualitative interviews with adult patients and caregivers to understand their experiences with racism and discrimination within the context of their experiences with screening and referral for SDOH; the investigators will then share their findings with stakeholders (e.g., clinic directors, community agency leaders, health system leaders, Medicaid leaders) and elicit their ideas on how best to address these issues within the systems they lead. Subsequently, the investigators will refine the WE CARE implementation protocol using this stakeholder input with the guidance of antiracism and implementation experts. The investigators will then implement the refined WE CARE protocol in family medicine clinics since adverse SDOH impact the whole family unit; it will also allow them to examine WE CARE's impact on improving health outcomes for racialized groups across the life course. The investigators will conduct a hybrid effectiveness-implementation study with a stepped wedge cluster RCT design in three large family medicine clinics (including 2 health centers) that serve racially/ethnically diverse low-income families from Worcester, Massachusetts. The specific aims are to:
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's planned enrollment of 68,000 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the usual care group receive standard pediatric care. In this study, participants in the Usual Care arm are a historical cohort of patients who meet eligibility criteria and are identified retrospectively from the Electronic Health Records. As such the investigators have registered this study on Clinical Trial.gov prior to the implementation of the active WE CARE experimental arm.
Other: Standard Pediatric Care
The study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site.
Other: WE CARE SDOH System
The WE CARE System: A family-centered, highly efficacious approach for addressing adverse SDOH in the clinical setting. Arvin Garg, MD, MPH developed and conceptualized the WE CARE (Well-Child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) intervention in 2005. This approach relies on existing clinical processes and infrastructure and social service resources, thereby making implementation, dissemination, and sustainability feasible. The intervention components include brief training of the clinical team; administration of a short screening tool to parents/patients identifying their desire for help with specific unmet social needs; and provider/clinic staff access to a physical or electronic family resource book containing community- resource listings. Providers generate referrals for families who indicate that they want help with unmet social needs on the WE CARE screener. Existing staff members may assist patients in connecting to referred resources.
Standard pediatric care includes any existing screening practices, which can vary at each clinic.
Blood pressure (BP) measurements
Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.
Time frame: Every 3 months for up to 3 years
LDL-C measurements
Laboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia.
Time frame: Every 3 months for up to 3 years
HbA1c measurements
Laboratory assessment for Hba1C levels for diabetes patients.
Time frame: Every 3 months for up to 3 years
Emergency department visits
All ED visits whether or not they lead to a hospitalization for children and adults. (total, Asthma related, non-emergent)
Time frame: Every 3 months for up to 3 years
Hospitalizations
Hospitalizations for children and adults (total, ACSC, Asthma related, CVD)
Time frame: Every 3 months for up to 3 years
Body mass index
Clinical BMI assessment
Time frame: Every 3 months for up to 3 years
Clinic visit adherence
Clinic visit attendance (appointment-keeping/no-shows)
Time frame: Every 3 months for up to 3 years
Adverse social determinants of health (SDOH)
Number/types of patient's unmet social needs
Time frame: Every 3 months for up to 3 years
Social determinants of health (SDOH) screening
Number of screeners given by providers to patients.
Time frame: Every 3 months for up to 3 years
Provider referrals
Number/types of referrals to social services given by providers to patients.
Time frame: Every 3 months for up to 3 years
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2028, 35 months after the start.
Of 166 non-industry interventional studies with no phase under Hyperlipidemias, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 35 months is above that.
Counting every sponsor, half of 171 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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University of Massachusetts, Worcester →