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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Elham Hatef, MD, MPHemail@example.com|
|Contact: Lauren Tansky, BSfirstname.lastname@example.org|
|Principal Investigator:||Elham Hatef, MD, MPH||Johns Hopkins University|