Social Needs Screening and Chronic Diseases Study (WE CARE)

NCT06903897 | Recruiting

• 2 other identifiers: STUDY000014991R01NR020752-01
• Study Type: interventional
• Target: 68,000
• Locations: 1 country
• Sites: 3

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?

Conditions

Hyperlipidemias; Diabetes; Depression; Pediatric Asthma; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• LDL-C measurements

  Every 3 months for up to 3 years

• HbA1c measurements

  Every 3 months for up to 3 years

• Emergency department visits

  Every 3 months for up to 3 years

• Hospitalizations

  Every 3 months for up to 3 years

Other Outcomes (5)

• Body mass index

  Every 3 months for up to 3 years

• Clinic visit adherence

  Every 3 months for up to 3 years

• Adverse social determinants of health (SDOH)

  Every 3 months for up to 3 years

Study Arms (2)

Usual Care - Control

ACTIVE COMPARATOR

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

WE CARE Implementation Arm

EXPERIMENTAL

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

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.

WE CARE Implementation Arm

Standard Pediatric Care OTHER

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

Usual Care - Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Nursing Research (NINR): collaborator
• Boston University: collaborator
• Boston Medical Center: collaborator
• Family Health Center of Worcester: collaborator

Study Sites (3)

(Benedict) UMass Memorial Medical Center - Adult Primary Care

Worcester, Massachusetts, 01605, United States

NOT YET RECRUITING

UMass Memorial Medical Center - Hahnemann Campus

Worcester, Massachusetts, 01605, United States

RECRUITING

Family Health Center of Worcester

Worcester, Massachusetts, 01610, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hyperlipidemias; Diabetes Mellitus; Depression; Hypertension

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Arvin Garg

CONTACT

4103363261‬; arvin.garg@umassmemorial.org

Jennifer Hazelton

CONTACT

9783370340‬; jennifer.hazelton@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)