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OpenTrials
Completed

NCT Number: NCT05228886

The SINCERE Intervention to Address COVID-19 Health Disparities

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Social Determinants of Health Virus Diseases Vulnerable Populations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SINCERE

Behavioral

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.

Scheduled Follow-Up

Behavioral

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.

Standard of care

Other

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

Primary outcomes

  1. Change in Global Health over 12-week time period

    Time frame: Baseline, 2-week, 4-week and 12-week surveys

    Standardized 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.

  2. Change in Depression over 12-week time period

    Time frame: Baseline, 2-week, 4-week and 12-week surveys

    Standardized 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.

  3. Change in Anxiety over 12-week time period

    Time frame: Baseline, 2-week, 4-week and 12-week surveys

    Standardized 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.

Sponsors and collaborators

Lead sponsor

Andrea Wallace

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: SINCERE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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