HyperlipidemiasNCT06903897
Social Needs Screening and Chronic Diseases Study (WE CARE)
A study testing WE CARE SDOH System and Standard Pediatric Care in people with Hyperlipidemias and Diabetes, run by University of Massachusetts, Worcester at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Diabetes, Depression
- What is being tested?
- WE CARE SDOH System and Standard Pediatric Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Oct 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UMass Memorial Medical Center - Hahnemann Campus
Worcester, Massachusetts, 01605
Arvin Garg, 410-336-3261, arvin.garg@umassmemorial.org
Jennifer Hazelton, 9783370340, jennifer.hazelton@umassmed.edu
- Not yet recruiting
Family Health Center of Worcester
Worcester, Massachusetts, 01610
Arvin Garg, MD, 410-336-3261, arvin.garg@umassmemorial.org
Jennifer Hazelton, 9783370340, jennifer.hazelton@umassmed.edu
- Not yet recruiting
UMass Memorial Medical Center -Benedict Family Medicine Clinic
Worcester, Massachusetts, 01655
Arvin Garg, MD, 4103363261, arvin.garg@umassmemorial.org
Jennifer B Hazelton, 978-337-0340, jennifer.hazelton@umassmed.edu
About this study
Official title: Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism
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?
Read the 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
- Conditions
- Hyperlipidemias, Diabetes, Depression, Pediatric Asthma, Hypertension
- Being tested
- WE CARE SDOH System, Standard Pediatric Care
- Keywords
- Basic Needs, Social Determinants of Health, Screening tools, Antiracism
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Depression, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE CARE SDOH SystemOther
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.
Standard Pediatric CareOther
Standard pediatric care includes any existing screening practices, which can vary at each clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard Pediatric Care |
| 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. Receives: Other: WE CARE SDOH System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (BP) measurements
Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.
Measured: Every 3 months for up to 3 years
Secondary outcomes (4)
LDL-C measurements
Laboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia.
Measured: Every 3 months for up to 3 years
HbA1c measurements
Laboratory assessment for Hba1C levels for diabetes patients.
Measured: 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)
Measured: Every 3 months for up to 3 years
Hospitalizations
Hospitalizations for children and adults (total, ACSC, Asthma related, CVD)
Measured: Every 3 months for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start8 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Boston University, Boston Medical Center, Family Health Center of Worcester
- Responsible party
- Principal investigator, Arvin Garg, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903897
- Sponsor's protocol ID
- STUDY00001499
- Other IDs
- 1R01NR020752-01
- Status last verified
- May 2026
- First submitted
- 25 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism
- ClinicalTrials.gov ID
- NCT06903897
- Acronym / sponsor ID
- STUDY00001499
- Conditions
- Hyperlipidemias, Diabetes, Depression, Pediatric Asthma, Hypertension
- Keywords
- Basic Needs, Social Determinants of Health, Screening tools, Antiracism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68,000 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Boston University, Boston Medical Center, Family Health Center of Worcester
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care - Control | Active comparator | Other: Standard Pediatric CareParticipants 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. |
| WE CARE Implementation Arm | Experimental | Other: WE CARE SDOH SystemThe study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WE CARE SDOH SystemThe 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. | Other | WE CARE Implementation Arm |
| Standard Pediatric CareStandard pediatric care includes any existing screening practices, which can vary at each clinic. | Other | Usual Care - Control |
Primary outcome
Blood pressure (BP) measurements
Time frame: Every 3 months for up to 3 years
Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE CARE SDOH System and Standard Pediatric Care in people with Hyperlipidemias and Diabetes, run by University of Massachusetts, Worcester at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arvin Garg (4103363261, arvin.garg@umassmemorial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (BP) measurements (time frame: Every 3 months for up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.