Social Needs Screening and Chronic Diseases Study (WE CARE)

Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism

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?

Study Overview

• Status: Recruiting
• Conditions: Depression; Hypertension; Diabetes; Hyperlipidemias; Pediatric Asthma
• Intervention / Treatment: Other: Standard Pediatric Care; Other: WE CARE SDOH System

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

• Study Type: Interventional
• Enrollment (Estimated): 68000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arvin Garg; Phone Number: 4103363261‬; Email: arvin.garg@umassmemorial.org
• Study Contact Backup: Name: Jennifer Hazelton; Phone Number: 9783370340‬; Email: jennifer.hazelton@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • UMass Memorial Medical Center - Hahnemann Campus
      • Contact: Jennifer Hazelton; Phone Number: 9783370340‬; Email: jennifer.hazelton@umassmed.edu
      • Contact: Arvin Garg; Phone Number: 410-336-3261; Email: arvin.garg@umassmemorial.org
      • Principal Investigator: Ron Adler, MD
    • Worcester, Massachusetts, United States, 01610
      • Not yet recruiting
      • Family Health Center of Worcester
      • Contact: Jennifer Hazelton; Phone Number: 9783370340‬; Email: jennifer.hazelton@umassmed.edu
      • Contact: Arvin Garg, MD; Phone Number: 410-336-3261; Email: arvin.garg@umassmemorial.org
      • Principal Investigator: Melanie Gnazzo, MD
    • Worcester, Massachusetts, United States, 01655
      • Not yet recruiting
      • UMass Memorial Medical Center -Benedict Family Medicine Clinic
      • Principal Investigator: Susan Hogan, MD
      • Contact: Arvin Garg, MD; Phone Number: 4103363261; Email: arvin.garg@umassmemorial.org
      • Contact: Jennifer B Hazelton; Phone Number: 978-337-0340; Email: jennifer.hazelton@umassmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: Standard Pediatric Care; Standard pediatric care includes any existing screening practices, which can vary at each clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (BP) measurements	Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.	Every 3 months for up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C measurements	Laboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia.	Every 3 months for up to 3 years
HbA1c measurements	Laboratory assessment for Hba1C levels for diabetes patients.	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)	Every 3 months for up to 3 years
Hospitalizations	Hospitalizations for children and adults (total, ACSC, Asthma related, CVD)	Every 3 months for up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Clinical BMI assessment	Every 3 months for up to 3 years
Clinic visit adherence	Clinic visit attendance (appointment-keeping/no-shows)	Every 3 months for up to 3 years
Adverse social determinants of health (SDOH)	Number/types of patient's unmet social needs	Every 3 months for up to 3 years
Social determinants of health (SDOH) screening	Number of screeners given by providers to patients.	Every 3 months for up to 3 years
Provider referrals	Number/types of referrals to social services given by providers to patients.	Every 3 months for up to 3 years

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Boston University; National Institute of Nursing Research (NINR); Boston Medical Center; Family Health Center of Worcester

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Social Determinants of Health; Screening tools; Basic Needs; Antiracism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Dyslipidemias; Lipid Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Hypertension; Depression; Diabetes Mellitus; Hyperlipidemias
• Other Study ID Numbers: STUDY00001499; 1R01NR020752-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No