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NCT06903897 | RECRUITING | Hyperlipidemias


Social Needs Screening and Chronic Diseases Study (WE CARE)
Sponsor:

University of Massachusetts, Worcester

Information provided by (Responsible Party):

Arvin Garg

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?

Condition or disease

Hyperlipidemias

Diabetes

Depression

Pediatric Asthma

Hypertension

Intervention/treatment

WE CARE SDOH System

Standard Pediatric Care

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 68000 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism
Actual Study Start Date : 2025-10-08
Estimated Primary Completion Date : 2028-09-30
Estimated Study Completion Date : 2028-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

Social Needs Screening and Chronic Diseases Study (WE CARE)

Location Details

NCT06903897


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


NOT YET RECRUITING

United States, Massachusetts

(Benedict) UMass Memorial Medical Center - Adult Primary Care

Worcester, Massachusetts, United States, 01605

RECRUITING

United States, Massachusetts

UMass Memorial Medical Center - Hahnemann Campus

Worcester, Massachusetts, United States, 01605

NOT YET RECRUITING

United States, Massachusetts

Family Health Center of Worcester

Worcester, Massachusetts, United States, 01610

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