Clinical trial NCT06903897: Social Needs Screening and Chronic Diseases Study (WE CARE)
Official title: Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperlipidemias
Diabetes
Depression
Pediatric Asthma
Hypertension
Keywords: Basic Needs
Social Determinants of Health
Screening tools
Antiracism
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Boston University
name: Boston Medical Center
name: Family Health Center of Worcester
First posted: 2025-04-01
Enrollment: 68000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A stepped wedge cluster Randomized Controlled Trial (RCT) will be conducted whereby we 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 us 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.
Primary purpose: SCREENING

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

Eligibility criteria: 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.

Primary outcomes:
measure: Blood pressure (BP) measurements
timeFrame: Every 3 months for up to 3 years
Secondary outcomes:
measure: LDL-C measurements
timeFrame: Every 3 months for up to 3 years
measure: HbA1c measurements
timeFrame: Every 3 months for up to 3 years
measure: Emergency department visits
timeFrame: Every 3 months for up to 3 years
measure: Hospitalizations
timeFrame: Every 3 months for up to 3 years
Other outcomes:
measure: Body mass index
timeFrame: Every 3 months for up to 3 years
measure: Clinic visit adherence
timeFrame: Every 3 months for up to 3 years
measure: Adverse social determinants of health (SDOH)
timeFrame: Every 3 months for up to 3 years
measure: Social determinants of health (SDOH) screening
timeFrame: Every 3 months for up to 3 years
measure: Provider referrals
timeFrame: Every 3 months for up to 3 years
Locations:
city: Worcester
country: United States
facility: (Benedict) UMass Memorial Medical Center - Adult Primary Care
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center - Hahnemann Campus
state: Massachusetts
city: Worcester
country: United States
facility: Family Health Center of Worcester
state: Massachusetts
Study officials:
References: