Social Risk Score + CDS Tool for Chronic Disease

No longer recruiting at 4 trial locations

Overseen By Kendrick Gwynn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Children, High income, Non-African American

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method to improve healthcare for African American patients with low income who have chronic diseases and face social challenges. Researchers use a social risk score and a digital tool, Clinical Decision Support for Social Needs, to help doctors identify patients' social needs and direct them to helpful resources. One group of patients will receive this new support system, while another group will continue with the usual care. African American adults with low income who face daily issues due to chronic diseases might be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions tailored to specific needs.

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 this social risk score and CDS tool is safe for use in chronic disease management?

Research shows that the Social Risk Score and Clinical Decision Support (CDS) tool identifies patients with social needs using electronic health records. Developers have tested and integrated this tool to ensure compatibility with current healthcare systems. Studies have shown that it helps healthcare providers find patients who might need extra support due to social challenges.

No evidence indicates safety concerns or negative effects from using the Social Risk Score and CDS tool. This is expected, as it identifies social needs rather than acting as a drug or medical device. It aids doctors and care managers in understanding patients' social situations, leading to more personalized care.

In summary, the Social Risk Score and CDS tool appears safe to use. It enables healthcare teams to offer better support to patients facing social challenges without posing any direct health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to address social needs in patients with chronic diseases. Unlike standard care, which often relies on providers manually assessing social needs and referring patients to services, this trial uses a Social Risk Score and a Clinical Decision Support (CDS) tool. The CDS tool automatically calculates a social risk score, helping providers quickly identify patients with high social needs. This streamlined approach aims to ensure more efficient and targeted referrals to social workers and community-based organizations, potentially improving patient outcomes by addressing social factors more effectively and promptly.

What evidence suggests that the Social Risk Score and CDS Tool could be effective for improving care for chronic diseases?

This trial will compare the use of a social risk score and clinical decision support (CDS) tool with standard care. Research has shown that using a social risk score and a CDS tool effectively identifies patients' social needs. By considering social factors like income and education, healthcare providers can better understand and address health disparities. Studies have found that integrating these tools into healthcare processes improves the quality of health information. This enhancement aids healthcare providers in making better decisions about patient care, particularly for those facing social and economic challenges. Early findings suggest these tools can lead to improved referrals and more personalized care for patients with chronic diseases. ^{1 4 6 7 8}

Who Is on the Research Team?

Elham Hatef, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adult African-American patients with low income who have chronic diseases like heart failure, diabetes, or high blood pressure. It's not open to children, people of other races, or those with higher incomes.

Inclusion Criteria

I am an adult African-American with low income.

Exclusion Criteria

Individuals with race other than African American

People who make a lot of money.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the social risk score and CDS tool in selected primary care clinics

4 weeks

Ongoing access through EHR

Randomized Controlled Trial (RCT)

Conduct RCT to assess the impact of the CDS tool on care processes and patient outcomes

3 months

Regular clinic visits as per standard care

Follow-up

3-month follow-up to assess changes in social determinants of health challenges and patient satisfaction

3 months

Telephone survey

What Are the Treatments Tested in This Trial?

Interventions

• Social Risk Score and CDS Tool
• Standard of Care

Trial Overview The study tests a new social risk score and clinical decision support tool against standard care in managing chronic diseases among underserved populations. The goal is to improve care by addressing social needs using health information technology.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Patients randomized into the control arm will be provided with the standard-of-care screening, assessment, and addressing social needs in the clinic setting. This would not include any automated mechanism of pre-collected data in the EHR. Currently providers on an ad-hoc basis apply a series of needs-assessment tools including one available within JHHS-EHR. Patients in the control arm that are identified as someone with social needs will then be referred to appropriate services through current standard-of-care mechanisms, this may include a sheet of various educational resources, or a list of organizations that can address the identified social need.

Group II: Social Risk Score and Closed Loop Referral Active Control 1 Intervention

Patients in intervention arm will have a social risk score available through the CDS tool, which the provider can review and decide whether the patient needs more assessment. If the patient is identified as with high social needs based on the risk score in the CDS tool, the providers will refer the patient to social workers/ care managers for further in-depth assessment of the participants social needs at HCC. HCC will reach out to the patients over the phone and will perform an in-depth assessment of the patients social needs. If any social needs are identified and patient agrees to address those needs HCC staff will refer the patient to CBOs.

Social Risk Score and CDS Tool is already approved in United States for the following indications:

Approved in United States as Social Risk Score and CDS Tool for:

• Identification and management of social needs in medically underserved populations with chronic diseases

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A framework was developed to evaluate the referral process for patients with social needs, identifying six key steps from screening to outcome, which was applied to 5741 patients at a COVID-19 vaccine clinic.

Out of 360 referrals accepted by community organizations, only 27% were resolved, highlighting significant challenges in the referral process, particularly issues with contacting patients and patients declining services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Framework for Evaluating Social Determinants of Health Screening and Referrals for Assistance. Chagin, K., Choate, F., Cook, K., et al.[2022]

The WellRx screening tool, tested on 3048 patients in three family medicine clinics over 90 days, identified that 46% of patients had at least one social need, many of which were previously unknown to their healthcare providers.

The successful implementation of WellRx not only improved the identification of social determinants of health but also led to its adoption in a university teaching hospital and influenced state health policy to require community health workers for Medicaid patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Social Determinants of Health in a Clinic Setting: The WellRx Pilot in Albuquerque, New Mexico. Page-Reeves, J., Kaufman, W., Bleecker, M., et al.[2022]

Incorporating social determinants like income and education into healthcare decisions has the potential to improve health outcomes, but it also risks worsening health inequities for certain patient groups.

The paper discusses three specific examples where including social risk information in healthcare policies could lead to reduced care quality or access, highlighting the need for a careful dialogue about the implications of these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Social and Medical Care: Could it Worsen Health and Increase Inequity? Gottlieb, LM., Alderwick, H.[2023]

A new social health screening (SHS) tool was developed based on feedback from health consumer advocates, patients, and clinicians, aimed at addressing social determinants of health (SDH) in clinical settings.

In a pilot study with 50 patients from anxiety and sleep disorder clinics, both patients and clinicians responded positively to the SHS tool, indicating its potential to enhance understanding of individual social circumstances and promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a screening tool to recognise social determinants of health in Australian clinical settings. Browne-Yung, K., Freeman, T., Battersby, M., et al.[2020]

The study developed electronic health record (EHR)-based clinical decision support (CDS) tools aimed at improving care for patients with social risks in community health centers, based on feedback from staff and patients.

Key features of the CDS tools include social risk screening, documentation, and functionalities like alerts to help providers adjust care plans according to patients' social needs, promoting better adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partner-developed electronic health record tools to facilitate social risk-informed care planning. Gunn, R., Pisciotta, M., Gold, R., et al.[2023]

A study comparing social risk factors in patients using screening questions and ICD-10 Z codes found that both methods had low accuracy, with AUC scores indicating they are not effective for identifying issues like financial strain and food insecurity.

Neither approach met the necessary diagnostic thresholds for usefulness, suggesting that improved data collection methods or technology integration may be needed to better assess patients' social risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity and Specificity of Real-World Social Factor Screening Approaches. Vest, JR., Wu, W., Mendonca, EA.[2022]

In a study of 21,402 inpatient admissions at the University of Virginia Medical Center, individual-level social risk factors were found to significantly increase the likelihood of unplanned hospital readmissions and post-discharge emergency department visits.

The research suggests that standardized screening tools for social determinants of health (SDoH) could improve the collection of social risk data, potentially leading to better patient outcomes by addressing these factors systematically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying individual social risk factors using unstructured data in electronic health records and their relationship with adverse clinical outcomes. Rikard, SM., Kim, B., Michel, JD., et al.[2022]

In a project involving 231 patients in Prince George's County, Maryland, 96.25% agreed to social determinant of health (SDOH) screening, revealing that 13.42% had at least one unmet social need, with social isolation being the most common.

The study demonstrated that implementing SDOH screening in primary care is feasible and can enhance the identification of patients' social needs, although follow-up on resource linkage was not conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Social Determinants of Health Among Medicare Beneficiaries in Primary Care During the Covid-19 Pandemic in Prince George's County, Maryland. Zhang, WJ., Fornili, K.[2023]

There is a significant gap in guidance for healthcare practitioners on how to address patients' social needs in clinical settings, despite evidence linking social circumstances to health outcomes.

The article proposes a three-tier framework for implementing social determinants interventions in healthcare, focusing on individual patients, healthcare institutions, and broader population strategies, along with methods for data collection and targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collecting and applying data on social determinants of health in health care settings. Gottlieb, L., Sandel, M., Adler, NE.[2022]

Routine screening for health-related social conditions (HRSC) is crucial, as about half of patients with such needs may go unrecognized without it, highlighting the importance of integrating these screenings into healthcare practices.

The review identified nine commonly used HRSC screening tools and assessed their effectiveness in capturing key social determinants of health, providing valuable recommendations for healthcare institutions to improve their screening processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Tools to Screen for Social Determinants of Health in the United States: A Practice Brief. Moen, M., Storr, C., German, D., et al.[2021]

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]

The implementation of the Core 5 social risk screening tool in a presurgical spine population successfully identified social risk factors in 59% of patients, highlighting the importance of addressing social determinants of health before surgery.

Staff reported high usability and acceptance of the screening tool, with an average score of 4.4 out of 5, indicating that it can be effectively integrated into clinical workflows to connect patients with necessary resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing screening for social determinants of health using the Core 5 screening tool. Bradywood, A., Leming-Lee, TS., Watters, R., et al.[2021]

Citations

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Social Risk Score, Clinical Decision Support Tool and ... Evaluate the acceptability of the social risk score/ CDS tool and its impact on the clinical workflow, patient care, and HIT data quality. To achieve these aims ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10966439/

Development of a Social Risk Score in the Electronic ... Achieving a comprehensive assessment of a person's health and addressing health disparities goes beyond just documenting clinical diseases and medical ...

3. researchprotocols.org researchprotocols.org/2024/1/e57316

Piloting a Clinical Decision Support Tool to Identify Patients ... The clinical provider will have the option of checking the risk score on the CDS tool, the summary of patients' previous social needs, and other ...

4. mcg.com mcg.com/blog/documenting-social-determinants-of-health/

The Value of Documenting Social Determinants of Health in ... By documenting factors such as race, ethnicity, income, education, and neighborhood characteristics, clinical professionals can gain insight ...

5. jmir.org jmir.org/2025/1/e73615

Integration of Screening and Referral Tools for Social ... Development and use of a clinical decision support tool for behavioral health screening in primary care clinics. Appl Clin Inform. Apr 26 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11303893/

Piloting a Clinical Decision Support Tool to Identify Patients ... The predictive risk score helps providers systematically identify patients at risk of having social needs based on their demographic characteristics, clinical ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S277306542500032X

An Electronic Health Record–Based Platform for Social ... The study team has developed an electronic health record–integrated platform, including a clinical decision support and closed-loop referral tool, ...

8. researchgate.net researchgate.net/publication/378906798_Development_of_a_Social_Risk_Score_in_the_Electronic_Health_Record_to_Identify_Social_Needs_Among_Underserved_Populations_Retrospective_Study

Development of a Social Risk Score in the Electronic ... ... Using both patient-and population-level data, we developed a social predictive risk score based entirely on electronic information readily available within ...