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

Trial Summary

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 data supports the effectiveness of the WE CARE SDOH System treatment for chronic disease?

The research highlights the importance of improving chronic illness care by adapting care systems to better meet patient needs, as described in the Chronic Care Model (CCM). This model has been used successfully in over 100 health care organizations to enhance chronic care, suggesting that system changes like those in the WE CARE SDOH System could be effective. ^{1 2 3 4 5}

How is the WE CARE SDOH System treatment different from other treatments for chronic disease?

The WE CARE SDOH System is unique because it focuses on addressing social determinants of health (SDOH), which are the conditions in which people live and work, as part of managing chronic diseases. This approach is different from traditional treatments that primarily focus on medical interventions, as it aims to improve overall health by considering factors like access to resources, social support, and community involvement. ^{6 7 8 9 10}

What is the purpose of this trial?

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?

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 we 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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes management: from concepts to application. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Improving chronic illness care: translating evidence into action. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Using health status measures in the hospital setting: from acute care to 'outcomes management'. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Exploration of an automated approach for receiving patient feedback after outpatient acute care visits. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes analysis: methods and issues. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Hospital-based chronic disease care model: protocol for an effectiveness and implementation evaluation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Improving primary care for patients with chronic illness. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

[Measurement of chronic conditions in a single person as a mortality predictor]. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Patient centered integrated clinical resource management. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

An integrated chronic disease management model: a diagonal approach to health system strengthening in South Africa. [2022]