Social Needs Screening and Chronic Diseases Study (WE CARE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Massachusetts, Worcester

About 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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • WE CARE SDOH System

    Other intervention

    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 Care

    Other intervention

    Standard pediatric care includes any existing screening practices, which can vary at each clinic.

Treatment groups

68,000 Participants
are divided into 2 treatment groups
Group A: Usual Care - ControlActive comparator 1 intervention
Group B: WE CARE Implementation ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood pressure (BP) measurements

Systolic and diastolic blood pressure measurements collected at all routine and follow-up visits for adults.

Time frame
Every 3 months for up to 3 years

Secondary outcomes

1

LDL-C measurements

Laboratory assessment for lipid (LDL-C) levels for adult patients with hyperlipidemia.

Time frame
Every 3 months for up to 3 years
2

HbA1c measurements

Laboratory assessment for Hba1C levels for diabetes patients.

Time frame
Every 3 months for up to 3 years
3

Emergency department visits

All ED visits whether or not they lead to a hospitalization for children and adults. (total, Asthma related, non-emergent)

Time frame
Every 3 months for up to 3 years
4

Hospitalizations

Hospitalizations for children and adults (total, ACSC, Asthma related, CVD)

Time frame
Every 3 months for up to 3 years

Other outcomes

1

Body mass index

Clinical BMI assessment

Time frame
Every 3 months for up to 3 years
2

Clinic visit adherence

Clinic visit attendance (appointment-keeping/no-shows)

Time frame
Every 3 months for up to 3 years
3

Adverse social determinants of health (SDOH)

Number/types of patient's unmet social needs

Time frame
Every 3 months for up to 3 years
4

Social determinants of health (SDOH) screening

Number of screeners given by providers to patients.

Time frame
Every 3 months for up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

Boston University

Collaborator

Boston Medical Center

Collaborator

Family Health Center of Worcester

Collaborator