Social Needs Screening and Chronic Diseases Study (WE CARE)

Not Applicable

Not yet recruiting

• Conditions: Hyperlipidemias; Diabetes; Depression; Pediatric Asthma; Hypertension

• Registration Number: NCT06903897
• Lead Sponsor: University of Massachusetts, Worcester

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, we 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. We 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; we will then share our 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, we will refine the WE CARE implementation protocol using this stakeholder input with the guidance of antiracism and implementation experts. We will then implement the refined WE CARE protocol in family medicine clinics since adverse SDOH impact the whole family unit; it will also allow us to examine WE CARE's impact on improving health outcomes for racialized groups across the life course. We 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. Our 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: 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 Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Study Start: 2025-08-01
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Blood pressure (BP) measurements	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 Outcome Measures

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

Trial Locations

Locations (3)

(Benedict) UMass Memorial Medical Center - Adult Primary Care; 🇺🇸 Worcester, Massachusetts, United States

UMass Memorial Medical Center - Hahnemann Campus; 🇺🇸 Worcester, Massachusetts, United States

Family Health Center of Worcester; 🇺🇸 Worcester, Massachusetts, United States