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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR020752-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Boston University | OTHER |
| Boston Medical Center | OTHER |
| Family Health Center of Worcester |
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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?
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care - Control | Active Comparator | 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 the investigators have registered this study on Clinical Trial.gov prior to the implementation of the active WE CARE experimental arm. |
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| WE CARE Implementation Arm | Experimental | The study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WE CARE SDOH System | Other | 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 include brief training of the clinical team; administration of a short screening tool to parents/patients identifying their desire for help with specific unmet social needs; and provider/clinic staff access to a physical or electronic family resource book containing community- resource listings. Providers generate referrals for families who indicate that they want help with unmet social needs on the WE CARE screener. Existing staff members may assist patients in connecting to referred resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure (BP) measurements | Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults. | Every 3 months for up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C measurements | Laboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia. | Every 3 months for up to 3 years |
| HbA1c measurements | Laboratory assessment for Hba1C levels for diabetes patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Clinical BMI assessment | Every 3 months for up to 3 years |
| Clinic visit adherence | Clinic visit attendance (appointment-keeping/no-shows) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arvin Garg | Contact | 4103363261 | arvin.garg@umassmemorial.org | |
| Jennifer Hazelton | Contact | 9783370340 | jennifer.hazelton@umassmed.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center - Hahnemann Campus | Recruiting | Worcester | Massachusetts | 01605 | United States |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| UNKNOWN |
A stepped wedge cluster Randomized Controlled Trial (RCT) will be conducted whereby the investigators 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 the investigators 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.
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| Standard Pediatric Care | Other | Standard pediatric care includes any existing screening practices, which can vary at each clinic. |
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| Every 3 months for up to 3 years |
| Emergency department visits | All ED visits whether or not they lead to a hospitalization for children and adults. (total, Asthma related, non-emergent) | Every 3 months for up to 3 years |
| Hospitalizations | Hospitalizations for children and adults (total, ACSC, Asthma related, CVD) | Every 3 months for up to 3 years |
| Every 3 months for up to 3 years |
| Adverse social determinants of health (SDOH) | Number/types of patient's unmet social needs | Every 3 months for up to 3 years |
| Social determinants of health (SDOH) screening | Number of screeners given by providers to patients. | Every 3 months for up to 3 years |
| Provider referrals | Number/types of referrals to social services given by providers to patients. | Every 3 months for up to 3 years |
| Family Health Center of Worcester | Not yet recruiting | Worcester | Massachusetts | 01610 | United States |
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| UMass Memorial Medical Center -Benedict Family Medicine Clinic | Not yet recruiting | Worcester | Massachusetts | 01655 | United States |
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| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |