Social Needs Screening and Chronic Diseases Study (WE CARE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WE CARE SDOH System, Standard Pediatric Care.
- Who it may be relevant to
- Registry conditions: Hyperlipidemias, Diabetes, Depression, Pediatric Asthma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism
Overview
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, 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
Interventions
- 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 inclu - Other Standard Pediatric Care
Standard pediatric care includes any existing screening practices, which can vary at each clinic.
Primary outcome measures
- Blood pressure (BP) measurements [Time frame: Every 3 months for up to 3 years]
Secondary outcome measures (4)
- LDL-C measurements [Time frame: Every 3 months for up to 3 years]
- HbA1c measurements [Time frame: Every 3 months for up to 3 years]
- Emergency department visits [Time frame: Every 3 months for up to 3 years]
- Hospitalizations [Time frame: Every 3 months for up to 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 3 centers
- UMass Memorial Medical Center - Hahnemann Campus — Worcester
- Family Health Center of Worcester — Worcester
- UMass Memorial Medical Center -Benedict Family Medicine Clinic — Worcester
Identifiers
NCT: NCT06903897 · STUDY00001499 · 1R01NR020752-01