Social Needs Screening and Chronic Diseases Study (WE CARE)

Conditions

• Depression
• Diabetes
• Hyperlipidemias
• Hypertension
• Pediatric Asthma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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?

Key Dates

Start date

Oct 8, 2025

Status verified

May 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

68,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

• Active Comparator: Usual Care - Control
  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.
• Experimental: WE CARE Implementation Arm
  The study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site.

Primary Outcome Measure

Blood pressure (BP) measurements [ Time Frame: Every 3 months for up to 3 years ]

Central Contacts

• Arvin Garg
  4103363261‬
  [email protected]
• Jennifer Hazelton
  9783370340‬
  [email protected]

Locations (3)

Find similar trials in Worcester, MA

Related Studies

• Brain Connectivity in Depression
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
• Imaging Histone Deacetylase in the Heart
  Recruiting · Massachusetts General Hospital · Boston, Massachusetts
• A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
  PHASE3 · Enrolling By Invitation · United Therapeutics · Phoenix, Arizona
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Phoenix, Arizona