The SINCERE Intervention to Address COVID-19 Health Disparities

COVID-19 Clinical Trial

— SINCERE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228886
• Other study ID #: 00140301
• Secondary ID: 1R01NR019944-01
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2023
• Source: University of Utah
• Contact: Erin Johnson, PhD
• Phone: 801-587-8578
• Email: erin.p.johnson[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Social Determinants of Health
• Vulnerable Populations

Intervention

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.
• 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.

Other:
• Standard of Care
211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Andrea Wallace	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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