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Social Risk Score, Clinical Decision Support Tool and Closed Loop Referral for Social Risk Screen and Referral

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ClinicalTrials.gov Identifier: NCT05574699
Recruitment Status : Not yet recruiting
First Posted : October 10, 2022
Last Update Posted : February 1, 2023
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Disease Diabetes Mellitus Hypertension Congestive Heart Failure Other: Social Risk Score and CDS Tool Other: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Piloting a Clinical Decision Support Tool to Identify and Refer Patients With Social Needs to Community-based Organizations
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Social Risk Score and Closed Loop Referral
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.
Other: Social Risk Score and CDS Tool
A social risk score, which helps to identify patients with high social needs based on the risk score in the CDS tool and a closed loop referral, which helps to refer the patients to CBOs, if needed.

Active Comparator: Control
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.
Other: Standard of Care
Currently available process for screening, assessment, and addressing social needs in the clinic setting, which may include providing a sheet of various educational resources, or a list of organizations that can address the identified social need.




Primary Outcome Measures :
  1. Change in the number of social needs identified during the visit [ Time Frame: Baseline and at 3 month follow-up ]
    The change in the number of social needs identified during the visit.


Secondary Outcome Measures :
  1. Difference in the number of patients with social needs identified in the intervention and control groups [ Time Frame: Baseline and at 3 month follow-up ]
    The difference in the number of patients with social needs identified in the control compared to intervention groups.

  2. Difference in the number of patients with social needs who receive services at a CBO in intervention and control groups [ Time Frame: Baseline and at 3 month follow-up ]
    The difference in the number of patients with social needs who receive services at a CBO between intervention and control arms.

  3. Change in the number of hospitalization events and emergency department (ED) visits between intervention and control arms [ Time Frame: Baseline and at 3 month follow-up ]
    The change in the number of hospitalization events and ED visits between intervention and control arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (18+ years old) African-American patients with low income at each clinic

Exclusion Criteria:

  • Children are excluded from this study. Individuals with high levels of income, and those with race other than African American

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05574699


Contacts
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Contact: Elham Hatef, MD, MPH 410-978-8006 ehatef1@jhu.edu
Contact: Lauren Tansky, BS 410-502-2656 ltansky@jhu.edu

Sponsors and Collaborators
Johns Hopkins University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Elham Hatef, MD, MPH Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05574699    
Other Study ID Numbers: IRB00354803
R01MD015844 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual patient data will be shared with other researchers beyond the approved study team members by Johns Hopkins institutional review board (IRB).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Chronic Disease
Cardiovascular Diseases
Heart Diseases
Disease Attributes
Pathologic Processes