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The SINCERE Intervention to Address COVID-19 Health Disparities

Intensifying Community Referrals for Health: The SINCERE Intervention to Address COVID-19 Health Disparities

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05228886
Acronym
SINCERE
Enrollment
466
Registered
2022-02-08
Start date
2021-09-27
Completion date
2025-09-30
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Social Determinants of Health, Vulnerable Populations

Brief summary

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.

Interventions

BEHAVIORALSINCERE

Each goal setting session will involve templated prompts in 211's ServicePoint to guide the creation of a patient-centered "action plan" specifying what, when, how much, and how often patients will engage in a behavior (e.g., "I will work on filling out eligibility paperwork for 30 minutes on Wednesday evening"). Again, following clear prompts, ISs negotiate the "action plan" with patients until patients can rate their level of confidence for achieving this behavior a 7 on a scale from 0 to 10.

BEHAVIORALScheduled Follow-Up

Adding to the standard Call + Resources protocol, those assigned to scheduled follow-up will receive a proactive call from 211 every 2 weeks for 3 months to explore additional service needs. These calls will be unstructured, guided by participant requests and 211 IS prompts.

OTHERStandard of Care

211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.

Sponsors

Andrea Wallace
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)

Masking description

Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Global Health over 12-week time periodBaseline, 2-week, 4-week and 12-week surveysStandardized PROMIS v1.2 Global Health. 10 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating lower severity. The outcome variable will be PROMIS v1.2 Global Health with Time included as a variable in the model.
Change in Depression over 12-week time periodBaseline, 2-week, 4-week and 12-week surveysStandardized PROMIS Depression - Short Form 8b. 8 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.
Change in Anxiety over 12-week time periodBaseline, 2-week, 4-week and 12-week surveysStandardized PROMIS Anxiety- Short Form 7a. 7 questions create one outcome score. Each question is on a 1-5 scale with higher numbers indicating higher severity. The outcome variable will be PROMIS Anxiety with Time included as a variable in the model.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrea Wallace, PhD

University of Utah

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026