The SINCERE Intervention to Address COVID-19 Health Disparities

Andrea Wallace

Status: Enrolling

Conditions: COVID-19; Social Determinants of Health; Vulnerable Populations

Treatments: Behavioral: SINCERE; Other: Standard of Care; Behavioral: Scheduled Follow-Up

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05228886

00140301

1R01NR019944-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic follow-up as a scalable strategy for preventing COVID-19 transmission, and for addressing the secondary health effects of the social, behavioral, and economic changes following the COVID-19 pandemic. With statewide community service providers, existing health information technology, and piloted methods, we seek to determine the effectiveness of universal social needs screening and community service referrals - the SINCERE intervention - in improving health outcomes of COVID-19 vulnerable and socioeconomically disadvantaged populations and whether intensive follow-up and collaborative goal-setting helps overcome barriers to community service use by patients seen in the emergency department and seeking COVID testing at community-based and mobile clinic locations.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult (> 17 years)
• English or Spanish speaking
• Completed the referral process at the UHealth ED, one of the COVID-19 testing sites or the Primary Children's ED and indicated both social needs and willingness to receive service low- and no-cost referrals from the United Way 211 community referral service
• Able to be reached by phone during the intervention OR able to complete surveys sent by text or email

Exclusion criteria

• Those unable to communicate verbally
• Those living in nursing facilities, or those who are not otherwise responsible for self-care

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

Call + Resources

Active Comparator group

Description:

Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.

Treatment:

Other: Standard of Care

Call + Resources + Scheduled Follow-Up

Experimental group

Description:

Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.

Treatment:

Behavioral: Scheduled Follow-Up

Call + Resources + SINCERE

Experimental group

Description:

Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the SINCERE intervention description (scheduled follow up with active collaborative goal setting).

Treatment:

Behavioral: SINCERE