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NCT Number: NCT06903897

Social Needs Screening and Chronic Diseases Study (WE CARE)

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?

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Center of Worcester, Worcester, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WE CARE SDOH System

Other

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

Other

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

Primary outcomes

  1. Blood pressure (BP) measurements

    Time frame: Every 3 months for up to 3 years

    Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.

Secondary outcomes

  1. LDL-C measurements

    Time frame: Every 3 months for up to 3 years

    Laboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia.

  2. HbA1c measurements

    Time frame: Every 3 months for up to 3 years

    Laboratory assessment for Hba1C levels for diabetes patients.

  3. Emergency department visits

    Time frame: Every 3 months for up to 3 years

    All ED visits whether or not they lead to a hospitalization for children and adults. (total, Asthma related, non-emergent)

  4. Hospitalizations

    Time frame: Every 3 months for up to 3 years

    Hospitalizations for children and adults (total, ACSC, Asthma related, CVD)

Other outcomes

  1. Body mass index

    Time frame: Every 3 months for up to 3 years

    Clinical BMI assessment

  2. Clinic visit adherence

    Time frame: Every 3 months for up to 3 years

    Clinic visit attendance (appointment-keeping/no-shows)

  3. Adverse social determinants of health (SDOH)

    Time frame: Every 3 months for up to 3 years

    Number/types of patient's unmet social needs

  4. Social determinants of health (SDOH) screening

    Time frame: Every 3 months for up to 3 years

    Number of screeners given by providers to patients.

  5. Provider referrals

    Time frame: Every 3 months for up to 3 years

    Number/types of referrals to social services given by providers to patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Arvin Garg

CONTACT

[email protected]

4103363261‬

Jennifer Hazelton

CONTACT

[email protected]

9783370340‬

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Boston Medical Center
  • Boston University
  • Family Health Center of Worcester
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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