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

Primary Purpose

COVID-19, Vulnerable Populations, Social Determinants of Health

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SINCERE
Scheduled Follow-Up
Standard of Care
Sponsored by
Andrea Wallace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Call + Resources

Call + Resources + Scheduled Follow-Up

Call + Resources + SINCERE

Arm Description

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

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

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2022
Last Updated
March 23, 2023
Sponsor
Andrea Wallace
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05228886
Brief Title
The SINCERE Intervention to Address COVID-19 Health Disparities
Acronym
SINCERE
Official Title
Intensifying Community Referrals for Health: The SINCERE Intervention to Address COVID-19 Health Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrea Wallace
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Vulnerable Populations, Social Determinants of Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Call + Resources
Arm Type
Active Comparator
Arm Description
Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.
Arm Title
Call + Resources + Scheduled Follow-Up
Arm Type
Experimental
Arm Description
Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.
Arm Title
Call + Resources + SINCERE
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
SINCERE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Scheduled Follow-Up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner.
Primary Outcome Measure Information:
Title
Change in Global Health over 12-week time period
Description
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.
Time Frame
Baseline, 2-week, 4-week and 12-week surveys
Title
Change in Depression over 12-week time period
Description
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.
Time Frame
Baseline, 2-week, 4-week and 12-week surveys
Title
Change in Anxiety over 12-week time period
Description
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.
Time Frame
Baseline, 2-week, 4-week and 12-week surveys

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Johnson, PhD
Phone
801-587-8578
Email
erin.p.johnson@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Wallace, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Wallace, PhD
Phone
801-585-9647
Email
andrea.wallace@nurs.utah.edu
First Name & Middle Initial & Last Name & Degree
Erin Johnson, PhD
Phone
801-587-8578
Email
erin.p.johnson@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

The SINCERE Intervention to Address COVID-19 Health Disparities

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