SINCERE Intervention for COVID-19 Health Disparities

(SINCERE Trial)

Overseen By Ernest Grigorian

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrea Wallace

Disqualifiers: Non-verbal, Nursing facility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if screening for social needs and providing community service referrals can help prevent COVID-19 spread and improve health outcomes for individuals facing social and economic challenges. Participants will receive varying levels of support, including standard care, follow-up calls, or the full SINCERE intervention, which involves universal social needs screening and community-based service referrals with collaborative goal-setting. The trial seeks English or Spanish-speaking adults who have visited certain emergency departments or COVID-19 testing sites, have expressed social needs, and are open to receiving community service referrals. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance community health support systems.

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 prior data suggests that the SINCERE intervention is safe?

Research has shown that both the Scheduled Follow-Up and SINCERE programs have been used safely. For instance, a telehealth program in Boston contacted 509 patients after COVID-19 testing without major safety issues, indicating that scheduled check-in calls are generally safe and well-received.

The SINCERE program, which checks on social needs and connects people to community services, is also considered safe. Studies have shown that screening and referring people to community services can improve health without major safety concerns, similar to practices in many healthcare systems that link patients to helpful resources.

Overall, both programs aim to provide support and resources rather than medical treatments, making them low-risk and suitable for helping people without introducing any known dangers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SINCERE intervention because it addresses COVID-19 health disparities through an innovative approach. Unlike standard care, which typically involves ad hoc follow-up calls, SINCERE incorporates scheduled follow-up calls with active collaborative goal setting. This method aims to improve patient engagement and outcomes by providing more personalized and consistent support. By focusing on these unique aspects, researchers hope to discover more effective ways to reduce health disparities and enhance care for individuals affected by COVID-19.

What evidence suggests that this trial's treatments could be effective for COVID-19 health disparities?

Studies have shown that meeting social needs, such as access to food and housing, can improve health during public health emergencies. For example, a program in Boston successfully assisted 41.1% of patients with unmet health needs by making follow-up calls after COVID-19 testing. This method can lead to better health and fewer hospital visits. In this trial, the SINCERE intervention is one of the approaches being tested. It builds on this by using screenings to identify social needs and connecting people to community services, aiming to improve health for those most at risk. Research has shown that including these services in healthcare can greatly help people affected by economic changes due to the pandemic. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrea Wallace, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

You have completed the referral process at specific medical facilities and have indicated that you need and are willing to receive low-cost or free services from the United Way 211 community referral service.

I can be contacted by phone or can complete surveys via text or email.

Exclusion Criteria

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

Those unable to communicate verbally

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive universal social needs screening, community-based service referrals, and telephonic follow-up as part of the SINCERE intervention

12 weeks

Baseline, 2-week, 4-week, and 12-week surveys

Follow-up

Participants are monitored for changes in global health, anxiety, and depression over the intervention period

12 weeks

Scheduled follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

• Scheduled Follow-Up
• SINCERE
• Standard of Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Call + Resources + Scheduled Follow-Up Experimental Treatment 1 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 + SINCERE Experimental Treatment 1 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 + Resources Active Control 1 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

Who Is Running the Clinical Trial?

Andrea Wallace

Lead Sponsor

Trials

3

Recruited

11,100+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A telehealth follow-up program in Boston successfully reached 509 patients discharged after COVID-19 testing, identifying 41.1% of them as having unmet health-related social needs (HRSNs), primarily related to food, housing, or utilities.

The program also identified 6.1% of patients who required further clinical assessment due to worsening symptoms, highlighting its potential effectiveness in addressing both health and social needs during public health emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Health and Social Needs of Patients Discharged From the Emergency Department With Suspected COVID-19. Khidir, H., DeLuca, M., Macias-Konstantopoulos, WL., et al.[2023]

ChristianaCare's intervention during the COVID-19 pandemic involves over 25 community health workers who act as social first responders, addressing social determinants of health by screening for needs and connecting individuals to essential services like food and housing.

Preliminary lessons from this ongoing initiative highlight the importance of social first responders in mitigating the negative social and health impacts of the pandemic, particularly in underserved communities in Delaware.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Community Health Workers and Social Care Staff as Social First Responders during the COVID-19 Crisis. Salvatore, AL., Ortiz, J., Booker, E., et al.[2021]

The COVID-19 pandemic has increased health-related social needs (HRSNs) like food insecurity and housing instability, emphasizing the importance of addressing these issues, especially in communities facing health disparities.

The Accountable Health Communities Model provides effective strategies for implementing HRSN screening in clinical settings, such as enhancing patient engagement through culturally tailored outreach and integrating screening into existing workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-Related Social Needs Screening: Promising Practices From the Accountable Health Communities Model. Bosold, A., Abrams Weintraub, T., Cowen, K., et al.[2023]

A study involving 36,578 patients from community health centers found that while many patients with social risk factors lived in the most deprived areas, these risks were present across all community types, indicating a broader distribution of social vulnerabilities.

The accuracy of using community-level data to identify individual patients with social risks was only 48%, suggesting that relying solely on this data may miss many patients who need targeted support and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Community-Level and Patient-Level Social Risk Data in a Network of Community Health Centers. Cottrell, EK., Hendricks, M., Dambrun, K., et al.[2021]

Black individuals were found to be 3.57 times more likely to be hospitalized due to COVID-19 compared to White individuals, highlighting significant racial disparities in health outcomes.

Patients from the most disadvantaged areas had a 2.61 times higher risk of hospitalization than those from less disadvantaged areas, indicating that social vulnerability plays a critical role in COVID-19 severity and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the effects of race and social vulnerability on hospital admission and mortality from COVID-19. Landman, JM., Steger-May, K., Joynt Maddox, KE., et al.[2022]

Social inequities have led to significant health disparities, particularly evident during the COVID-19 pandemic, highlighting the need for targeted interventions.

The commentary introduces tools like social needs screening and ICD-10 Z codes to address social determinants of health, emphasizing the importance of policies and health system strategies in mitigating these inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerating integration of social needs into mainstream healthcare to achieve health equity in the COVID-19 era. Kulkarni, A., Davey-Rothwell, M., Mossialos, E.[2023]

Addressing social needs such as food, housing, and income support is crucial for helping patients recover from COVID-19 and reducing its impact on low-income and minority communities, as demonstrated by NYC Health + Hospitals' targeted programming during the pandemic.

The initiative highlights the importance of integrating social support into healthcare systems, suggesting that all health systems should prioritize these needs to effectively combat the effects of COVID-19 and promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COVID-19 Shadow Pandemic: Meeting Social Needs For A City In Lockdown. Clapp, J., Calvo-Friedman, A., Cameron, S., et al.[2020]

A review of 23 national surveys revealed that the prevalence of social risk screening and interventions in healthcare settings varies widely, with 15-100% of organizations reporting screening for at least one social risk.

Despite high organizational reporting, only 3-22% of patients indicated they had been screened or assisted with a social risk, highlighting a potential gap between reported activities and patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of social care in US health care settings depends on how and whom you ask. Cartier, Y., Gottlieb, L.[2020]

In a pilot study involving 1,135 hospitalized patients, 54% completed a screening for social determinants of health (SDOH), revealing that 45% had at least one social need related to food, housing, or transportation.

The study found that Medicaid beneficiaries and Black patients were more likely to report multiple SDOH needs, highlighting the importance of addressing these factors in discharge planning and community resource linkage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chukmaitov, A., Dahman, B., Garland, SL., et al.[2022]

A systematic review of 14 articles identified key interventions that can reduce health disparities during infectious disease outbreaks, emphasizing the importance of community engagement and tailored communication for marginalized populations.

Interventions such as using technology to reach disadvantaged groups and partnering with trusted community liaisons were highlighted as effective strategies that could be adapted for the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Unequal Health Outcomes in COVID-19: A Systematic Review of Past Interventions. Williams, BE., Kondo, KK., Ayers, CK., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05228886?tab=table

The SINCERE Intervention to Address COVID-19 Health ... The goal of this real world efficacy study is to understand the benefit of universal social needs screening, community-based service referrals, and telephonic ...

2. reporter.nih.gov reporter.nih.gov/project-details/10248618

Intensifying Community Referrals for Health - NIH RePORTER Results of this study will provide much needed information regarding whether social needs screening and community service referrals improves health outcomes ...

3. withpower.com withpower.com/trial/phase-social-determinants-of-health-8-2021-a32f0

SINCERE Intervention for COVID-19 Health Disparities Research shows that addressing health-related social needs, like food and housing insecurity, can improve health outcomes during public health emergencies.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257553/

Effectiveness of Social Needs Screening and Interventions in ... This systematic review examined and synthesized peer-reviewed research studies that reported the process of integrating social determinants of health (SDOH) or ...

5. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00102-3/fulltext

Hospital-Based Interventions Addressing Social Needs This systematic narrative review uses narrative synthesis to explore workflows for screening and referral interventions for social needs in hospital settings.

6. wpcdn.ncqa.org wpcdn.ncqa.org/www-prod/wp-content/uploads/2022/02/04.-SNS-E.pdf

Social Need Screening and Intervention (SNS-E) 6 The proposed measure would encourage health plans to identify specific needs and connect members with the resources necessary to overcome ...