Social Needs Screening and Chronic Diseases Study (WE CARE)

University of Massachusetts, Worcester

Status: Not yet enrolling

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

Treatments: Other: Standard Pediatric Care; Other: WE CARE SDOH System

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06903897

STUDY00001499

1R01NR020752-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Full 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

Enrollment: 68,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68,000 participants in 2 patient groups

Usual Care - Control

Active Comparator group

Description:

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 we have registered this study on Clinical Trial.gov prior to the implementation of the active WE CARE experimental arm.

Treatment:

Other: Standard Pediatric Care

WE CARE Implementation Arm

Experimental group

Description:

The study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site.

Treatment:

Other: WE CARE SDOH System