An interventional study of Social Risk Score and CDS Tool and Standard of Care in Chronic Disease, Diabetes Mellitus and Hypertension, sponsored by Johns Hopkins University. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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.
The aim of this phase of the study is to
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.
991 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 251 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
Number of Emergency Department Events
Number of emergency department visits, extracted from EHR
Time frame: 12 and 24 months follow-up
Number of Hospitalization Events
Number of unplanned hospitalization
Time frame: 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.
Time frame: From baseline to the end of follow up period (24 months)
We identified potentially eligible patients through the Johns Hopkins Health System EHR system in the participating clinics. Eligibility criteria included being an adult (aged ≥18 years) residing in socioeconomically challenged neighborhoods in Baltimore City. After eligibility verification and introduction to the study, interested patients completed IRB-approved informed consent using DocuSign or in person at the clinic. Enrollment and randomization occurred on a rolling basis.
| Milestone | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening |
|---|---|---|---|---|
| Started | 62 | 64 | 106 | 19 |
| Completed | 62 | 64 | 106 | 19 |
| Not completed | 0 | 0 | 0 | 0 |
Number of emergency department visits, extracted from EHR
| events | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening |
|---|---|---|---|---|
| Number of emergency department visits at 12 months follow-up | 0.93 ± 1.53 | 2.77 ± 4.56 | 1.85 ± 6.4 | 1.77 ± 2.09 |
| Number of emergency department visits at 24 months follow-up | 1.09 ± 2.41 | 3.28 ± 6.69 | 3.59 ± 16.51 | 1.09 ± 1.30 |
Number of unplanned hospitalization
| events | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening |
|---|---|---|---|---|
| Number of Hospitalization Events at 12 months follow-up | 0.19 ± 0.60 | 0.7 ± 1.87 | 0.52 ± 1.57 | 0.29 ± 0.73 |
| Number of Hospitalization Events at 24 months follow-up | 0.17 ± 0.60 | 0.69 ± 1.48 | 0.55 ± 1.78 | 0.15 ± 0.36 |
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.
| social needs | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening |
|---|---|---|---|---|
| Number of social needs at baseline | 0 (0 to 0) | 2.00 (1.00 to 4.00) | 0 (0 to 0) | 2.00 (1.00 to 3.00) |
| Number of social needs from baseline to the last follow-up | 3.00 (3.00 to 3.00) | 3.00 (3.00 to 5.00) | 3.00 (2.75 to 3.25) | 3.00 (2.00 to 4.00) |
| Number of social needs resolved at the last follow-up | 0.00 (0.00 to 3.00) | 3.00 (2.00 to 4.00) | 2.50 (1.50 to 3.00) | 2.00 (1.50 to 3.00) |
Collected over from baseline up to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group - Without Screening | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Intervention Group - With Screening | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
| Control Group - Without Screening | 0/106 (0%) | 0/106 (0%) | 0/106 (0%) |
| Control Group - With Screening | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(Years) | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening | Total |
|---|---|---|---|---|---|
| Mean | 55.66 ± 16.56 | 53.59 ± 13.30 | 53.00 ± 13.87 | 52.89 ± 11.84 | 53.80 ± 14.27 |
| Sex: Female, Male(Participants) | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening | Total |
|---|---|---|---|---|---|
| Female | 42 | 46 | 71 | 14 | 173 |
| Male | 20 | 18 | 35 | 5 | 78 |
| Race/Ethnicity, Customized(Participants) | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening | Total |
|---|---|---|---|---|---|
| White | 5 | 6 | 11 | 3 | 25 |
| Black | 52 | 53 | 88 | 14 | 207 |
| Others | 5 | 5 | 7 | 2 | 19 |
| Social risk score at enrollment(score on a scale) | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening | Total |
|---|---|---|---|---|---|
| Mean | 0.27 ± 0.12 | 0.52 ± 0.17 | 0.34 ± 0.17 | 0.42 ± 0.14 | 0.38 ± 0.18 |
| No. of emergency department visits at enrollment(events) | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening | Total |
|---|---|---|---|---|---|
| Mean | 0.94 ± 1.54 | 2.72 ± 4.33 | 1.34 ± 2.41 | 1.79 ± 1.93 | 1.63 ± 2.91 |
| No. of hospitalization events at enrollment(events) | Intervention Group - Without Screening | Intervention Group - With Screening | Control Group - Without Screening | Control Group - With Screening | Total |
|---|---|---|---|---|---|
| Mean | 0.18 ± 0.46 | 0.72 ± 1.94 | 0.45 ± 1.13 | 0.32 ± 0.67 | 0.44 ± 1.27 |
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Plan to share: 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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