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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05228886
Other study ID # 00140301
Secondary ID 1R01NR019944-01
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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