The SINCERE Intervention to Address COVID-19 Health Disparities

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Vulnerable Populations, Social Determinants of Health

Intervention / Treatment
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* Behavioral: SINCERE
* Behavioral: Scheduled Follow-Up
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |