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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR019944-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Call + Resources | Active Comparator | Participants receive standard care typically provided to 211 callers, including ad hoc follow-up. |
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| Call + Resources + Scheduled Follow-Up | Experimental | Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description. |
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| Call + Resources + SINCERE | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SINCERE | Behavioral | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Wallace, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Services to which participants are referred will not be aware of the participant's inclusion in the research study or their study arm.
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| Scheduled Follow-Up | Behavioral | 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. |
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| Standard of Care | Other | 211 ISs contact referred patients, provide referral services, and follow up in an ad-hoc manner. |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |