The SINCERE Intervention to Address COVID-19 Health Disparities

NCT05228886 | Recruiting

• 2 other identifiers: 001403011R01NR019944-01
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vulnerable Populations; Social Determinants of Health

Outcome Measures

Primary Outcomes (3)

• Change in Global Health over 12-week time period

  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.

  Baseline, 2-week, 4-week and 12-week surveys

• Change in Depression over 12-week time period

  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.

  Baseline, 2-week, 4-week and 12-week surveys

• Change in Anxiety over 12-week time period

  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.

  Baseline, 2-week, 4-week and 12-week surveys

Study Arms (3)

Call + Resources

ACTIVE COMPARATOR

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

Other: Standard of Care

Call + Resources + Scheduled Follow-Up

EXPERIMENTAL

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

Behavioral: Scheduled Follow-Up

Call + Resources + SINCERE

EXPERIMENTAL

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).

Behavioral: SINCERE

Interventions

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.

Call + Resources + SINCERE

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.

Call + Resources + Scheduled Follow-Up

Standard of Care OTHER

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

Call + Resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Andrea Wallace: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrea Wallace, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernest Grigorian

CONTACT

801-707-2775; ernest.grigorian@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 8, 2022
• Study Start: September 27, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)