WE CARE SDOH System for Chronic Disease

Recruiting at 2 trial locations

Overseen By Jennifer Hazelton

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: No chronic disease diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

68000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the WE CARE social determinants of health (SDOH) system can reduce chronic diseases by focusing on health equity for racial and ethnic minorities. It will test whether this approach improves conditions such as high blood pressure, diabetes, depression, high cholesterol, and asthma. The trial compares the WE CARE system with usual care methods to assess its effectiveness. Suitable participants include those with ongoing issues like asthma, diabetes, hypertension, high cholesterol, or depression who receive care at one of the study locations. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research focused on health equity and chronic disease management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on social determinants of health rather than medication changes.

What prior data suggests that the WE CARE SDOH System is safe for use in primary care settings?

Research has shown that the WE CARE SDOH System targets social factors affecting health, such as living and working conditions. This system aids in managing chronic conditions like high blood pressure, diabetes, and asthma.

Studies have found that the WE CARE system can be effectively implemented in busy healthcare settings. It involves screening and referrals to identify and address social issues impacting health.

The sources provided report no negative effects from using the WE CARE SDOH System. Since this trial does not involve a new drug or invasive treatment but rather a screening and referral process, it is generally considered safe for participants. The trial aims to evaluate its effectiveness in reducing health disparities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WE CARE SDOH System because it aims to integrate social determinants of health (SDOH) into chronic disease management, which is a relatively new approach. Unlike traditional treatments that focus solely on medical interventions, the WE CARE System collaborates with clinic staff to address factors like access to healthy food, housing stability, and social support. By tackling these broader issues, the system hopes to improve patient outcomes in ways that current treatments might not fully achieve. This comprehensive approach has the potential to revolutionize how chronic diseases are managed by considering the whole patient, not just their symptoms.

What evidence suggests that the WE CARE SDOH System is effective for reducing chronic diseases?

Research has shown that addressing social factors affecting health can improve conditions like high blood pressure, diabetes, and asthma. This trial implements the WE CARE SDOH System to identify and address social needs, such as access to food and housing, linked to these health issues. A review of studies has found that incorporating these social factors into healthcare can provide significant health benefits. By reducing social obstacles, the WE CARE approach aims to lessen health disparities among racial and ethnic minorities. Studies have demonstrated that these efforts can lead to better management of chronic diseases. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

The WE CARE Chronic Disease Study is for individuals with chronic conditions like high cholesterol, diabetes, childhood asthma, high blood pressure, or depression. It's designed to see if a new health screening and referral system can help reduce these issues and improve overall care.

Inclusion Criteria

I have a chronic condition like hypertension, diabetes, high cholesterol, asthma, or depression and get care from a study site's Family Medicine.

I am 18 or older with diabetes, high blood pressure, high cholesterol, or depression.

Eligible study participants will be identified via the electronic health record retrospectively

Exclusion Criteria

My condition matches one of the eligible diagnoses.

I am under 18 and do not have asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Interviews

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.

4-6 weeks

Implementation

Implement the refined WE CARE protocol in family medicine clinics to assess its impact on improving health outcomes for racialized groups.

3 years

Routine visits every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• WE CARE SDOH System

Trial Overview This trial tests the 'WE CARE SDOH System', which screens for social factors affecting health and provides referrals as needed. It will be compared to standard pediatric care to see if it better manages chronic diseases while addressing racial/ethnic health disparities.

How Is the Trial Designed?

Group I: WE CARE Implementation Arm Experimental Treatment 1 Intervention

The study team will work with clinic staff and leadership to implement the WE CARE protocol at each clinical site.

Group II: Usual Care - Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Family Health Center of Worcester

Collaborator

Trials

2

Recruited

68,300+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Patient outcomes research can enhance the quality of care by improving how healthcare is delivered, focusing on both structures and processes.

Collaboration among different healthcare disciplines is essential for effectively analyzing outcomes, which can help identify cost-effective practices that lead to better patient results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes analysis: methods and issues. Jones, KR.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06903897

Social Needs Screening and Chronic Diseases Study (WE ... 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 ...

2. withpower.com withpower.com/trial/phase-hyperlipidemias-4-2025-e916f

WE CARE SDOH System for Chronic Disease What data supports the effectiveness of the WE CARE SDOH System treatment for chronic disease? The research highlights the importance of improving chronic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257553/

Effectiveness of Social Needs Screening and Interventions in ... This systematic review examined and synthesized peer-reviewed research studies that reported the process of integrating social determinants of health (SDOH) or ...

4. cdc.gov cdc.gov/pcd/issues/2025/24_0539.htm

Trends in Multiple Chronic Conditions Among US Adults ... In 2023, 76.4% (representing 194 million) of US adults reported 1 or more chronic conditions, including 59.5%, 78.4%, and 93.0% of young, midlife, and older ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000107

Addressing adverse social determinants of health in ... This hybrid type 2 effectiveness-implementation trial aims to demonstrate the non-inferiority of a low-touch implementation strategy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6868301/

Universal Screening for Social Determinants of Health in ... The aims of this study were to determine the feasibility of universal screening for SDoH in a busy subspeciality clinic using pre-existing resources.

7. childhealthequitycenter.org childhealthequitycenter.org/we-care/

WE CARE WE CARE screening tool was developed by Arvin Garg, MD, MPH to test a family-centered system to address adverse social determinants of health.

8. bmc.org bmc.org/pediatrics-primary-care/we-care/we-care-model

The WE CARE Model WE CARE is a social determinants of health (SDoH) screening and referral intervention. SDoH are the social circumstances in which people are born, work, live, ...

9. cdc.gov cdc.gov/pcd/issues/2024/24_0362.htm

Social Determinants of Health and Health-Related ... We sought to determine relationships between SDOH/HRSN and major chronic diseases among US adults by using data from the 2022 Behavioral Risk ...