600 Participants Needed

Social Risk Score + CDS Tool for Chronic Disease

Recruiting at 4 trial locations
LT
EH
IF
GB
KG
Overseen ByKendrick Gwynn
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged populations with chronic diseases.In the previous phases of this project the investigators developed a social risk score to identify social needs among medically under-served patients with special emphasis on application among African American patients with low income and chronic diseases who face social determinants, risk factors, and needs (SDRN) challenges. The investigators also developed a clinical decision support (CDS) tool to present the social risk score to clinical providers and sought feedback from different users on the face and content validity of the CDS tool.In the current project the investigators will run a randomized clinical trial (RCT) study to pilot test the new risk score and CDS tool in selected primary care clinics at Johns Hopkins Health System (JHHS) and in collaboration with selected community-based organizations (CBOs). This system will help identify, manage, and refer patients with both high levels of disease burden and modifiable SDRN challenges.

Will I have to stop taking my current medications?

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

Is the Social Risk Score + CDS Tool for Chronic Disease safe for humans?

The research articles do not provide specific safety data for the Social Risk Score + CDS Tool or similar tools, but they discuss the use of these tools in identifying social risk factors and their potential impact on health care delivery.12345

How is the Social Risk Score + CDS Tool treatment different from other treatments for chronic disease?

This treatment is unique because it focuses on identifying and addressing social factors that affect health, such as housing and food access, through a screening tool and decision support system, rather than just medical symptoms. It helps healthcare providers connect patients with community resources to address these social needs, which are often overlooked in traditional medical treatments.678910

What data supports the effectiveness of the Social Risk Score + CDS Tool for Chronic Disease treatment?

Research shows that screening for social determinants of health (like financial concerns or social isolation) in clinical settings can identify unmet social needs and improve referrals to appropriate services. This approach has been shown to be feasible and beneficial in improving provider practice and connecting patients with necessary resources, which can positively impact health outcomes.3691112

Who Is on the Research Team?

EH

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?
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Group II: Social Risk Score and Closed Loop ReferralActive Control1 Intervention

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:

Find a Clinic Near You

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

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.
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]
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.
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 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.
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]

Citations

Addressing Social Determinants of Health in a Clinic Setting: The WellRx Pilot in Albuquerque, New Mexico. [2022]
A Review of Tools to Screen for Social Determinants of Health in the United States: A Practice Brief. [2021]
Screening for Social Determinants of Health Among Medicare Beneficiaries in Primary Care During the Covid-19 Pandemic in Prince George's County, Maryland. [2023]
Implementing screening for social determinants of health using the Core 5 screening tool. [2021]
Collecting and applying data on social determinants of health in health care settings. [2022]
Integrating Social and Medical Care: Could it Worsen Health and Increase Inequity? [2023]
Identifying individual social risk factors using unstructured data in electronic health records and their relationship with adverse clinical outcomes. [2022]
Partner-developed electronic health record tools to facilitate social risk-informed care planning. [2023]
Sensitivity and Specificity of Real-World Social Factor Screening Approaches. [2022]
10.United Statespubmed.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. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A Framework for Evaluating Social Determinants of Health Screening and Referrals for Assistance. [2022]
Developing a screening tool to recognise social determinants of health in Australian clinical settings. [2020]
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