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

NCT05574699 | Completed DMC

• 2 other identifiers: IRB00354803R01MD015844
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Disease; Diabetes Mellitus; Hypertension; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in the number of social determinants of health (SDOH) challenges identified during the visit at 3-month follow-up telephone survey compared to the baseline visit.

  The independent evaluator will contact patients at 3 months follow-up to assess whether the SDOH challenges identified during the visit were properly addressed. Change (decrease or increase) in the number of SDOH challenges and the type of SDOH challenge (e.g., housing issue, food insecurity, transportation issue) will be documented.

  3 month follow-up

Secondary Outcomes (3)

• Difference in the number of patients with social needs identified in the intervention and control groups

  Baseline and at 3 month follow-up

• Difference in the number of patients with social needs who receive services at a CBO in intervention and control groups

  Baseline and at 3 month follow-up

• Change in the number of hospitalization events and emergency department (ED) visits between intervention and control arms

  Baseline and at 3 month follow-up

Study Arms (2)

Social Risk Score and Closed Loop Referral

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

Social Risk Score and CDS Tool OTHER

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.

Social Risk Score and Closed Loop Referral

Standard of Care OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (5)

Johns Hopkins GreenSpring Station

Baltimore, Maryland, 21093, United States

Location

Johns Hopkins Community Physicians - EBMC

Baltimore, Maryland, 21202, United States

Location

Johns Hopkins Community Physicians - Remington

Baltimore, Maryland, 21211, United States

Location

Johns Hopkins Bayview Medical Center - Comprehensive Care Practice

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins JHOC-GIM Clinic

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Hatef E, Richards T, Hail S, Zhang T, Topel K, Kitchen C, Shaw KC, Weiner JP. An Electronic Health Record-Based Platform for Social Needs Assessment and Navigation Services: Preliminary Results of an RCT. AJPM Focus. 2025 Apr 7;4(4):100344. doi: 10.1016/j.focus.2025.100344. eCollection 2025 Aug.

  PMID: 40475024 DERIVED

• Hatef E, Richards T, Topel K, Hail S, Kitchen C, Shaw K, Zhang T, Lasser EC, Weiner JP. Piloting a Clinical Decision Support Tool to Identify Patients With Social Needs and Provide Navigation Services and Referral to Community-Based Organizations: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jul 23;13:e57316. doi: 10.2196/57316.

  PMID: 39042426 DERIVED

MeSH Terms

Conditions

Chronic Disease; Diabetes Mellitus; Hypertension; Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elham Hatef, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: April 30, 2023
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)