Chronic DiseaseNCT05574699
Social Risk Score, Clinical Decision Support Tool and Closed Loop Referral for Social Risk Screen and Referral
A study testing Social Risk Score and CDS Tool in people with Chronic Disease and Diabetes Mellitus, run by Johns Hopkins University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Diabetes Mellitus, Hypertension
- What is being tested?
- Social Risk Score and CDS Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Apr 2023to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18+ years old) African-American patients with low income at each clinic
Who cannot join
- Children are excluded from this study. Individuals with high levels of income, and those with race other than African American
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins GreenSpring Station
Baltimore, Maryland, 21093
Johns Hopkins Community Physicians - EBMC
Baltimore, Maryland, 21202
Johns Hopkins Community Physicians - Remington
Baltimore, Maryland, 21211
Johns Hopkins Bayview Medical Center - Comprehensive Care Practice
Baltimore, Maryland, 21224
Johns Hopkins JHOC-GIM Clinic
Baltimore, Maryland, 21287
About this study
Official title: Piloting a Clinical Decision Support Tool to Identify and Refer Patients With Social Needs to Community-based Organizations
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.
Read the detailed description
The aim of this phase of the study is to
- Implement the social risk score and CDS tool developed and tested in the study. The CDS tool will help providers in primary care clinics to identify patients with social needs and refer patients to relevant CBOs.
- Assess the impact of the social risk score/ CDS tool on care processes and patient outcomes compared to the standard of care.
- 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 The investigators take the following approach;
Aim 1: The CDS tool will be implemented in the following four pilot primary care clinics; General Internal Medicine, Johns Hopkins Outpatient Clinic (GIM-JHOC), Johns Hopkins Community Physicians (JHCP) at Remington and Dundalk, as well as East Baltimore Medical Center (EBMC). The CDS tool is an electronic health record (EHR) based tool and the implementation will be completed by the Technology Innovation Center at Johns Hopkins Health System (TIC) team. The investigators have been working closely with the TIC team to complete the development of the CDS tool. Using a pre-developed EHR tool (i.e., Patient Insight) the TIC team is in the process of finalizing the CDS tool in Johns Hopkins Health System (JHHS) EHR. The CDS tool will then be available as one of the tabs in each patient's EHR main page and providers in each of the selected clinics (e.g., physicians, nurses, social workers and care managers) can access the CDS tool through EHR.
Aim 2: To assess the impact of the CDS tool the investigators will conduct an RCT. The investigators will enroll eligible patients from the pilot clinics who agree to participate in the investigators' study and sign the consent form. The investigators will work with Institute for Clinical and Translational Research (ICTR) team (contact person: Cassie Lewis-Land) to contact eligible patients via MyChart to inform the patients about the study and to obtain the consent form. The investigators will then randomize the patients to intervention or control arms.
For patients in the intervention arm the providers use the CDS tool to review the patients' social risk score. If the patient is identified as with high social needs based on the risk score in the CDS tool, the providers will refer the patients to social workers/ care managers for further in-depth assessment of the patients' social needs. The further assessment of the social needs will be performed by the Hopkins Community Connections (HCC), a group of social workers and community health workers currently acting as a hub for social needs assessment and referral at JHHS. Providers of different clinics across JHHS can refer patients to HCC for further assessment of the patients' social needs. 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.
HCC uses the FindHelp, a HIPAA compliant database and referral platform for social needs, both for communications with providers (i.e., receiving patients with social needs for further assessment from providers in the pilot clinics) and with CBOs (i.e., referring patients with social needs to CBOs). The investigators are working with 3 CBOs in Baltimore city including "Green \& Health Home Initiative", "Movable Feast", and "Franciscan Center" in this study, which are mostly equipped to address 3 major categories of social needs; residential instability, food insecurity, and transportation issues. Depending on the type of the social needs identified by the HCC team the investigators may consider engaging other CBOs that HCC is currently working with. After in-depth assessment of the social needs HCC staff will generate a summary report through FindHelp and alert the CBOs about the referred patients. CBOs will also have access to FindHelp and can review patients' social needs assessment and summary report. After meeting with the referred patient and identifying resources to address the patients' social needs CBOs generate a summary report, which will be accessible by HCC.
The control arm of the study will be provided with the standard-of-care screening, assessing, and addressing of social needs. The assessment will not be automated with pre-collected information as is designed in the investigators' CDS tool. The assessment will be on an ad-hoc basis, which may include completing currently available social needs screening tools in the clinics and providing information to the patients about available community based resources.
3 months after enrollment the staff at HCC will conduct a telephone survey with the patients enrolled in the study to assess whether the social needs still exist, to what degree the patients' needs were met, and satisfaction with the process for identifying and addressing the social needs as well as with the services the patients received. In addition to the telephone survey, the investigators will conduct a secondary data analysis to assess the impact of the CDS tool and referral system.
Aim 3: After the completion of the RCT the investigators will conduct an evaluation of the CDS and referral system from a health system perspective. The investigators will conduct focus groups/interviews with providers, social workers/care managers at HCC, and CBO staff to determine satisfaction of the tool, determine if there are any facilitators or barriers to using the system, and provide the study team with thoughts on ways to improve the system.
- Being tested
- Social Risk Score and CDS Tool, Standard of Care
- Medical subject headings
- Chronic Disease, Diabetes Mellitus, Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Risk Score and CDS ToolOther
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Events
Number of emergency department visits, extracted from EHR
Measured: 12 and 24 months follow-up
Secondary outcomes (2)
Number of Hospitalization Events
Number of unplanned hospitalization
Measured: 12 and 24 months follow-up
Number of Resolved Social Needs
This outcome measure identified how many of the social needs identified at baseline and during the study period were resolved at the end of the follow up period.
Measured: From baseline to the end of follow up period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start30 Apr 2023
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Elham Hatef, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574699
- Sponsor's protocol ID
- IRB00354803
- Other IDs
- R01MD015844
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2022
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data will be shared with other researchers beyond the approved study team members by Johns Hopkins institutional review board (IRB).
Publications
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.
PubMed 40475024Hatef 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.
PubMed 39042426
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Clinical Decision Support Tool to Identify and Refer Patients With Social Needs to Community-based Organizations
- ClinicalTrials.gov ID
- NCT05574699
- Acronym / sponsor ID
- IRB00354803
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this phase of the study is to
- Implement the social risk score and CDS tool developed and tested in the study. The CDS tool will help providers in primary care clinics to identify patients with social needs and refer patients to relevant CBOs.
- Assess the impact of the social risk score/ CDS tool on care processes and patient outcomes compared to the standard of care.
- 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 The investigators take the following approach;
Aim 1: The CDS tool will be implemented in the following four pilot primary care clinics; General Internal Medicine, Johns Hopkins Outpatient Clinic (GIM-JHOC), Johns Hopkins Community Physicians (JHCP) at Remington and Dundalk, as well as East Baltimore Medical Center (EBMC). The CDS tool is an electronic health record (EHR) based tool and the implementation will be completed by the Technology Innovation Center at Johns Hopkins Health System (TIC) team. The investigators have been working closely with the TIC team to complete the development of the CDS tool. Using a pre-developed EHR tool (i.e., Patient Insight) the TIC team is in the process of finalizing the CDS tool in Johns Hopkins Health System (JHHS) EHR. The CDS tool will then be available as one of the tabs in each patient's EHR main page and providers in each of the selected clinics (e.g., physicians, nurses, social workers and care managers) can access the CDS tool through EHR.
Aim 2: To assess the impact of the CDS tool the investigators will conduct an RCT. The investigators will enroll eligible patients from the pilot clinics who agree to participate in the investigators' study and sign the consent form. The investigators will work with Institute for Clinical and Translational Research (ICTR) team (contact person: Cassie Lewis-Land) to contact eligible patients via MyChart to inform the patients about the study and to obtain the consent form. The investigators will then randomize the patients to intervention or control arms.
For patients in the intervention arm the providers use the CDS tool to review the patients' social risk score. If the patient is identified as with high social needs based on the risk score in the CDS tool, the providers will refer the patients to social workers/ care managers for further in-depth assessment of the patients' social needs. The further assessment of the social needs will be performed by the Hopkins Community Connections (HCC), a group of social workers and community health workers currently acting as a hub for social needs assessment and referral at JHHS. Providers of different clinics across JHHS can refer patients to HCC for further assessment of the patients' social needs. 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.
HCC uses the FindHelp, a HIPAA compliant database and referral platform for social needs, both for communications with providers (i.e., receiving patients with social needs for further assessment from providers in the pilot clinics) and with CBOs (i.e., referring patients with social needs to CBOs). The investigators are working with 3 CBOs in Baltimore city including "Green \& Health Home Initiative", "Movable Feast", and "Franciscan Center" in this study, which are mostly equipped to address 3 major categories of social needs; residential instability, food insecurity, and transportation issues. Depending on the type of the social needs identified by the HCC team the investigators may consider engaging other CBOs that HCC is currently working with. After in-depth assessment of the social needs HCC staff will generate a summary report through FindHelp and alert the CBOs about the referred patients. CBOs will also have access to FindHelp and can review patients' social needs assessment and summary report. After meeting with the referred patient and identifying resources to address the patients' social needs CBOs generate a summary report, which will be accessible by HCC.
The control arm of the study will be provided with the standard-of-care screening, assessing, and addressing of social needs. The assessment will not be automated with pre-collected information as is designed in the investigators' CDS tool. The assessment will be on an ad-hoc basis, which may include completing currently available social needs screening tools in the clinics and providing information to the patients about available community based resources.
3 months after enrollment the staff at HCC will conduct a telephone survey with the patients enrolled in the study to assess whether the social needs still exist, to what degree the patients' needs were met, and satisfaction with the process for identifying and addressing the social needs as well as with the services the patients received. In addition to the telephone survey, the investigators will conduct a secondary data analysis to assess the impact of the CDS tool and referral system.
Aim 3: After the completion of the RCT the investigators will conduct an evaluation of the CDS and referral system from a health system perspective. The investigators will conduct focus groups/interviews with providers, social workers/care managers at HCC, and CBO staff to determine satisfaction of the tool, determine if there are any facilitators or barriers to using the system, and provide the study team with thoughts on ways to improve the system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Risk Score and Closed Loop Referral | Active comparator | Other: Social Risk Score and CDS ToolPatients 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. |
| Control | Active comparator | Other: Standard of CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18+ years old) African-American patients with low income at each clinic
Key exclusion criteria (1 listed)
- Children are excluded from this study. Individuals with high levels of income, and those with race other than African American
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Risk Score and CDS ToolA 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. | Other | Social Risk Score and Closed Loop Referral |
| Standard of CareCurrently 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. | Other | Control |
Primary outcome
Number of Emergency Department Events
Time frame: 12 and 24 months follow-up
Number of emergency department visits, extracted from EHR
2 secondary outcomes
Number of Hospitalization Events
Time frame: 12 and 24 months follow-up
Number of Resolved Social Needs
Time frame: From baseline to the end of follow up period (24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40475024Hatef 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.
- Derived from this study: PubMed 39042426Hatef 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham Hatef, MD, MPH principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Risk Score and CDS Tool in people with Chronic Disease and Diabetes Mellitus, run by Johns Hopkins University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Emergency Department Events (time frame: 12 and 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05574699, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.