The SINCERE Intervention to Address COVID-19 Health Disparities (SINCERE)

Intensifying Community Referrals for Health: 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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Social Determinants of Health; Vulnerable Populations
• Intervention / Treatment: Other: Standard of Care; Behavioral: Scheduled Follow-Up; Behavioral: SINCERE

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ernest Grigorian; Phone Number: 801-707-2775; Email: ernest.grigorian@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Andrea Wallace, PhD; Phone Number: 801-585-9647; Email: andrea.wallace@nurs.utah.edu
      • Contact: Ernest Grigorian, M.S.; Phone Number: 801-585-7194; Email: ernest.grigorian@utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Call + Resources; Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.	Other: Standard of Care; 211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.
Experimental: Call + Resources + Scheduled Follow-Up; 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; 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.
Experimental: Call + Resources + SINCERE; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Andrea Wallace
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Andrea Wallace, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): March 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 00140301; 1R01NR019944-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In agreement with the investigative team, the PI will share de-identified data to other investigators for study. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the Aims. De-identified data will be available directly from the PI after consulting with the investigative team on relevant requests. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No