~0 spots leftby Mar 2025

SINCERE Intervention for COVID-19 Health Disparities (SINCERE Trial)

Recruiting in Palo Alto (17 mi)
Overseen ByAndrea Wallace, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Andrea Wallace
No Placebo Group
Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial aims to see if checking people's social needs, connecting them with community services, and providing ongoing support can help prevent COVID-19 spread and improve health. It focuses on those who are vulnerable to COVID-19 and face economic challenges. By understanding their needs and providing support, the goal is to help them access necessary services and improve their overall well-being.
Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SINCERE Intervention for COVID-19 Health Disparities treatment?

Research shows that addressing health-related social needs, like food and housing insecurity, can improve health outcomes during public health emergencies. Programs that use telehealth follow-ups and community service referrals have been effective in identifying and addressing these needs, which are important components of the SINCERE Intervention.

12345
Is the SINCERE Intervention generally safe for humans?

The research articles reviewed do not provide specific safety data for the SINCERE Intervention or its related programs. They focus on addressing social needs and health disparities, but do not mention any safety concerns related to the intervention itself.

13678
How is the SINCERE treatment different from other COVID-19 treatments?

The SINCERE treatment is unique because it focuses on addressing social needs like food and housing insecurity, which can impact health outcomes, rather than just medical symptoms. It involves screening for these needs and connecting patients to community resources, making it different from traditional medical treatments that focus solely on the virus itself.

125910

Eligibility Criteria

This trial is for adults over 17 who have social needs and are willing to get help from community services after visiting certain emergency departments or COVID-19 testing sites. They must be reachable by phone or able to complete surveys online, and speak English or Spanish. It's not for those in nursing homes or unable to communicate verbally.

Inclusion Criteria

I am older than 17 years.

Exclusion Criteria

I live in a nursing facility or need help with daily activities.

Participant Groups

The SINCERE intervention includes universal screening for social needs, referrals to community services, and follow-up calls. The study tests if these steps can prevent COVID-19 spread among vulnerable groups and improve health outcomes following the pandemic's socioeconomic impacts.
3Treatment groups
Experimental Treatment
Active Control
Group I: Call + Resources + Scheduled Follow-UpExperimental Treatment1 Intervention
Participants receive standard care typically provided to 211 callers plus scheduled follow-up calls according to the Scheduled Follow-Up intervention description.
Group II: Call + Resources + SINCEREExperimental Treatment1 Intervention
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).
Group III: Call + ResourcesActive Control1 Intervention
Participants receive standard care typically provided to 211 callers, including ad hoc follow-up.
SINCERE is already approved in United States for the following indications:
🇺🇸 Approved in United States as SINCERE Intervention for:
  • Preventing COVID-19 transmission
  • Addressing secondary health effects of social, behavioral, and economic changes following the COVID-19 pandemic

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
University of UtahSalt Lake City, UT
Loading ...

Who is running the clinical trial?

Andrea WallaceLead Sponsor
National Institute of Nursing Research (NINR)Collaborator

References

The Health and Social Needs of Patients Discharged From the Emergency Department With Suspected COVID-19. [2023]Health-related social needs (HRSNs), such as food or housing insecurity, are important drivers of disparities in outcomes during public health emergencies. We describe the development of a telehealth follow-up program in Boston, Massachusetts, for patients discharged from the emergency department after coronavirus disease 2019 (COVID-19) testing to identify patients with worsening clinical symptoms, to screen for unmet HRSNs, and to deliver self-isolation counseling and risk-reduction strategies for socially vulnerable people. We prioritized telephone calls to patients with public health insurance and patients without primary care physicians. In the first 43 days of operation, March 30-May 12, 2020, our intervention reached 509 patients, with 209 (41.1%) patients reporting an HRSN, most commonly related to food, housing, or utilities. Thirty-one (6.1%) patients required assessment by a clinician for clinical worsening. This public health intervention may be useful for other institutions developing programs to address the social and health needs of patients discharged with suspected COVID-19.
Health-Related Social Needs Screening: Promising Practices From the Accountable Health Communities Model. [2023]Health-related social needs (HRSNs), such as food insecurity and housing instability, drive health and well-being. The socioeconomic impacts of the COVID-19 pandemic increased the prevalence of HRSNs and highlighted the critical need for strategies to address those needs, particularly in communities experiencing health disparities. Implementing HRSN screening requires adopting effective strategies to overcome common challenges. This report synthesizes promising implementation approaches and lessons learned from the Accountable Health Communities Model, a national effort funded by the Centers for Medicare & Medicaid Services Innovation Center to systematically screen for and address HRSNs in clinical settings. Key strategies include increasing patient engagement and building trust through culturally tailored language and outreach; using and sharing data for monitoring and improvement; using technology to expand access to screening and referrals; dedicating staff to screening roles; integrating screening into existing workflows; and building buy-in among staff by communicating the impact of screening and encouraging peer connections.
Addressing social risk factors in the inpatient setting: Initial findings from a screening and referral pilot at an urban safety-net academic medical center in Virginia, USA. [2022]Social Determinants of Health (SDOH) impact health outcomes; thus, a pilot to screen for important SDOH domains (food, housing, and transportation) and address social needs in hospitalized patients was implemented in an urban safety-net academic medical center. This study describes the pilot implementation and examines patient characteristics associated with SDOH-related needs. An internal medicine unit was designated as a pilot site. Outreach workers approached eligible patients (n = 1,135) to complete the SDOH screening survey at time of admission with 54% (n = 615) completing the survey between May 2019 and July 2020. Data from patient screening survey and electronic health records were linked to allow for examination of associations between SDOH needs for food, housing, and transportation and various demographic and clinical characteristics of patients in multivariate logistic regression models. Of 615 screened patients, 45% screened positive for any need. Of 275 patients with needs, 33% reported needs in 2, and 34% - in 3 domains. Medicaid beneficiaries were more likely than patients with private health insurance to screen positive for 2 and 3 needs; Black patients were more likely than White patients to screen positive for 1 and 3 needs; Patients with no designated primary care physician status screened positive for 1 need; Patients with a history of substance use disorder screened positive for all 3 needs. SDOH screening assisted in addressing social risk factors of inpatients, informed their discharge plans and linkage to community resources. SDOH screening demonstrated significant correlations of positive screens with race/ethnicity, insurance type, and certain clinical characteristics.
Preventing Unequal Health Outcomes in COVID-19: A Systematic Review of Past Interventions. [2022]Background: We sought to identify interventions that reduced disparities in health outcomes in infectious disease outbreaks or natural disasters in the United States to understand whether these interventions could reduce health disparities in the current COVID-19 pandemic. Methods: We searched MEDLINE and other databases to May 2020 to find studies that examined interventions to mitigate health inequalities in previous infectious disease pandemics or disasters. We assessed study quality using the Newcastle-Ottawa Scale and the Critical Appraisal Skills Program (CASP) Checklist for Qualitative Studies. Results: We included 14 articles (12 studies) and 5 Centers for Disease Control (CDC) stakeholder meeting articles on pandemic influenza preparedness in marginalized populations. Studies called for intervention and engagement before pandemic or disaster onset. Several studies included interventions that could be adapted to COVID-19, including harnessing technology to reach disadvantaged populations, partnering with trusted community liaisons to deliver important messaging around disease mitigation, and using culturally specific communication methods and messages to best reach marginalized groups. Discussion: To our knowledge this is the first systematic review to examine interventions to mitigate health inequities during an infectious disease pandemic. However, given that we identified very few disparities-focused infectious disease intervention studies, we also included studies from the disaster response literature, which may not be as generalizable to the current context of COVID-19. Overall, community outreach and tailored communication are essential in disease mitigation. More research is needed to evaluate systemic interventions that target the distal determinants of poor health outcomes among marginalized populations during pandemics and natural disasters.
Accelerating integration of social needs into mainstream healthcare to achieve health equity in the COVID-19 era. [2023]It is known that social inequities result in health disparities in outcomes, highlighted in the coronavirus disease 2019 (COVID-19) pandemic. This commentary discusses the actionable initiatives that have been implemented to address social inequities in healthcare in the United States. The publicly available social needs screening tools and International Classification of Disease Systems-10 Z codes for social determinants of health are introduced. In this context, policies, health system strategies and the larger role of implementation science in recognizing and alleviating the social needs are discussed.
Estimating the effects of race and social vulnerability on hospital admission and mortality from COVID-19. [2022]To estimate the risk of hospital admission and mortality from COVID-19 to patients and measure the association of race and area-level social vulnerability with those outcomes.
The prevalence of social care in US health care settings depends on how and whom you ask. [2020]Despite unprecedented enthusiasm for integrating social risk screening and related interventions into US health care settings, we know relatively little about the extent to which these activities occur. We reviewed results from multiple national surveys that reported on the prevalence of social care activities.
Comparison of Community-Level and Patient-Level Social Risk Data in a Network of Community Health Centers. [2021]Responding to the substantial research on the relationship between social risk factors and health, enthusiasm has grown around social risk screening in health care settings, and numerous US health systems are experimenting with social risk screening initiatives. In the absence of standard social risk screening recommendations, some health systems are exploring using publicly available community-level data to identify patients who live in the most vulnerable communities as a way to characterize patient social and economic contexts, identify patients with potential social risks, and/or to target social risk screening efforts.
Engaging Community Health Workers and Social Care Staff as Social First Responders during the COVID-19 Crisis. [2021]In this public health practice vignette, we describe an ongoing community and system intervention to identify and address social determinants of health and related needs experienced by ChristianaCare patients and the greater community during the Coronavirus pandemic. This intervention, being conducted by the ChristianaCare Office of Health Equity, in partnership with ChristianaCare's embedded research institute, the Value Institute, and the Community Outreach and Education division of the Helen F. Graham Cancer Center and Research Institute, engages more than 25 community health workers, health Guides, Latinx health promoters and other social care staff as social first responders during the COVID-19 crisis. These experienced front-line social care staff screen patients and community members for social needs; make referrals to agencies and organizations for needed assistance (e.g., food, housing, financial assistance); assess people's understanding of COVID-19 and preventive measures; provide education about COVID-19; and, connect patients and community members to COVID-19 testing and any relevant clinical services. While this ongoing intervention is under evaluation, we share here some preliminary lessons-learned and discuss the critical role that social first responders can play in reducing the growing adverse social and health impacts of COVID-19 across the state of Delaware.
10.United Statespubmed.ncbi.nlm.nih.gov
The COVID-19 Shadow Pandemic: Meeting Social Needs For A City In Lockdown. [2020]Addressing patients' social needs is key to helping them heal from coronavirus disease 2019 (COVID-19), preventing the spread of the virus, and reducing its disproportionate burden on low-income communities and communities of color. New York City Health + Hospitals is the city's single largest health care provider to Medicaid and uninsured patients. In response to the COVID-19 pandemic, NYC Health + Hospitals staff developed and executed a strategy to meet patients' intensified social needs during the COVID-19 pandemic. NYC Health + Hospitals identified food, housing, and income support as patients' most pressing needs and built programming to quickly connect patients to these resources. Although NYC Health + Hospitals was able to build on its existing foundation of strong social work support of patients, all health systems must prioritize the social needs of patients and their families to mitigate the damage of COVID-19. National and local leaders should accelerate change by developing robust policy approaches to redesign the social and economic system that reinforces structural inequity and exacerbates crises such as COVID-19.