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Social Needs Screening and Chronic Diseases Study (WE CARE)

Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06903897
Enrollment
68000
Registered
2025-04-01
Start date
2025-10-08
Completion date
2028-09-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Diabetes, Hyperlipidemias, Hypertension, Pediatric Asthma

Keywords

Basic Needs, Social Determinants of Health, Screening tools, Antiracism

Brief summary

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?

Detailed description

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: * Aim 1: Refine the WE CARE implementation protocol using an antiracism lens and community engagement approach to: (a) conduct key informant interviews with families to identify racism and discrimination related barriers to SDOH screening/referral; (b) present these barriers to systems-level stakeholders to elicit input on strategies to address patient concerns; and 3) create an antiracist informed toolkit for the implementation of SDOH screening/referral.).\* * Aim 2: Deploy the refined WE CARE protocol in family medicine practices and assess implementation outcomes including equity, appropriateness, and patient-centeredness * Aim 3: Conduct a clinical trial to evaluate the effectiveness of the refined WE CARE protocol on prevalent pediatric and adult chronic diseases (e.g., asthma, diabetes, hyperlipidemia, hypertension, depression) outcomes

Interventions

OTHERWE 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.

OTHERStandard Pediatric Care

Standard pediatric care includes any existing screening practices, which can vary at each clinic.

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Boston University
CollaboratorOTHER
Boston Medical Center
CollaboratorOTHER
Family Health Center of Worcester
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

A stepped wedge cluster Randomized Controlled Trial (RCT) will be conducted whereby the investigators will provide the intervention to all participants but stagger the timing of introduction to compare practices to one another and to compare practices to themselves, before and after implementation of the WE CARE model. This design minimizes the risk of contamination at the practice level, equitably implements the model in all clinical sites (vs. withholding in a traditional RCT design) and allows the investigators to simultaneously test the implementation and effectiveness of WE CARE in all study sites. Research staff at the study sites will abstract medical records (of adults and children with chronic diseases that are eligible (have diagnosis of hypertension, diabetes mellitus, hyperlipidemia, or depression for adults or have diagnosis of asthma for children) for administration of the WE CARE screener on a regular basis.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Adults and children with diagnosed chronic diseases (hypertension, diabetes mellitus, hyperlipidemia, asthma, or depression) who receive Family Medicine care at one of the study sites. * Children (\<18 years of age) with a diagnosis of asthma. * Adult patients (18 years or older) with a diagnosis of diabetes mellitus, hypertension, hyperlipidemia and/or depression.

Exclusion criteria

* In adults (\>18 years of age), those without one or more of the following diagnoses as recorded by ICD-10 codes in their EHR: hypertension, hyperlipidemia, diabetes mellitus, or depression. * In children (\<18 years of age), those without a diagnosis of asthma.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure (BP) measurementsEvery 3 months for up to 3 yearsSystolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.

Secondary

MeasureTime frameDescription
LDL-C measurementsEvery 3 months for up to 3 yearsLaboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia.
HbA1c measurementsEvery 3 months for up to 3 yearsLaboratory assessment for Hba1C levels for diabetes patients.
Emergency department visitsEvery 3 months for up to 3 yearsAll ED visits whether or not they lead to a hospitalization for children and adults. (total, Asthma related, non-emergent)
HospitalizationsEvery 3 months for up to 3 yearsHospitalizations for children and adults (total, ACSC, Asthma related, CVD)

Countries

United States

Contacts

CONTACTArvin Garg
arvin.garg@umassmemorial.org4103363261‬
CONTACTJennifer Hazelton
jennifer.hazelton@umassmed.edu9783370340‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026