Trial Outcomes & Findings for Social Risk Score, Clinical Decision Support Tool and Closed Loop Referral for Social Risk Screen and Referral (NCT NCT05574699)
NCT ID: NCT05574699
Last Updated: 2026-07-15
Results Overview
Number of emergency department visits, extracted from EHR
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
251 participants
Primary outcome timeframe
12 and 24 months follow-up
Results posted on
2026-07-15
Participant Flow
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.
Participant milestones
| Measure |
Intervention Group - Without Screening
Patients in the intervention group where information provided in the EHR-based CDS tool (e.g., the calculated social risk score) suggested that the patient did not require an additional social needs assessment
|
Intervention Group - With Screening
Patients in the intervention group where the information provided in the CDS tool (e.g., a high social risk score) suggested that high social needs may be present
|
Control Group - Without Screening
Control group where patients did not receive a clinician applied social needs assessment as a standard of care
|
Control Group - With Screening
Control group where patients did receive social needs assessment as a standard of care without provider's access to the EHR-based CDS tool
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
64
|
106
|
19
|
|
Overall Study
COMPLETED
|
62
|
64
|
106
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social risk score ranges from 0 to 1, with larger score presenting a higher chance of a patient being at risk of having a social need.
Baseline characteristics by cohort
| Measure |
Intervention Group - Without Screening
n=62 Participants
Patients in the intervention group where information provided in the EHR-based CDS tool (e.g., the calculated social risk score) suggested that the patient did not require an additional social needs assessment
|
Intervention Group - With Screening
n=64 Participants
Patients in the intervention group where the information provided in the CDS tool (e.g., a high social risk score) suggested that high social needs may be present
|
Control Group - Without Screening
n=106 Participants
Control group where patients did not receive a clinician applied social needs assessment as a standard of care
|
Control Group - With Screening
n=19 Participants
Control group where patients did receive social needs assessment as a standard of care without provider's access to the EHR-based CDS tool
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.66 Years
STANDARD_DEVIATION 16.56 • n=20 Participants
|
53.59 Years
STANDARD_DEVIATION 13.30 • n=20 Participants
|
53.00 Years
STANDARD_DEVIATION 13.87 • n=40 Participants
|
52.89 Years
STANDARD_DEVIATION 11.84 • n=5 Participants
|
53.80 Years
STANDARD_DEVIATION 14.27 • n=9 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
71 Participants
n=40 Participants
|
14 Participants
n=5 Participants
|
173 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
78 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
25 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black
|
52 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
14 Participants
n=5 Participants
|
207 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Others
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
|
Social risk score at enrollment
|
0.27 score on a scale
STANDARD_DEVIATION 0.12 • n=20 Participants • Social risk score ranges from 0 to 1, with larger score presenting a higher chance of a patient being at risk of having a social need.
|
0.52 score on a scale
STANDARD_DEVIATION 0.17 • n=20 Participants • Social risk score ranges from 0 to 1, with larger score presenting a higher chance of a patient being at risk of having a social need.
|
0.34 score on a scale
STANDARD_DEVIATION 0.17 • n=40 Participants • Social risk score ranges from 0 to 1, with larger score presenting a higher chance of a patient being at risk of having a social need.
|
0.42 score on a scale
STANDARD_DEVIATION 0.14 • n=5 Participants • Social risk score ranges from 0 to 1, with larger score presenting a higher chance of a patient being at risk of having a social need.
|
0.38 score on a scale
STANDARD_DEVIATION 0.18 • n=9 Participants • Social risk score ranges from 0 to 1, with larger score presenting a higher chance of a patient being at risk of having a social need.
|
|
No. of emergency department visits at enrollment
|
0.94 events
STANDARD_DEVIATION 1.54 • n=20 Participants
|
2.72 events
STANDARD_DEVIATION 4.33 • n=20 Participants
|
1.34 events
STANDARD_DEVIATION 2.41 • n=40 Participants
|
1.79 events
STANDARD_DEVIATION 1.93 • n=5 Participants
|
1.63 events
STANDARD_DEVIATION 2.91 • n=9 Participants
|
|
No. of hospitalization events at enrollment
|
0.18 events
STANDARD_DEVIATION 0.46 • n=20 Participants
|
0.72 events
STANDARD_DEVIATION 1.94 • n=20 Participants
|
0.45 events
STANDARD_DEVIATION 1.13 • n=40 Participants
|
0.32 events
STANDARD_DEVIATION 0.67 • n=5 Participants
|
0.44 events
STANDARD_DEVIATION 1.27 • n=9 Participants
|
PRIMARY outcome
Timeframe: 12 and 24 months follow-upNumber of emergency department visits, extracted from EHR
Outcome measures
| Measure |
Intervention Group - Without Screening
n=62 Participants
Patients in the intervention group where information provided in the EHR-based CDS tool (e.g., the calculated social risk score) suggested that the patient did not require an additional social needs assessment
|
Intervention Group - With Screening
n=64 Participants
Patients in the intervention group where the information provided in the CDS tool (e.g., a high social risk score) suggested that high social needs may be present
|
Control Group - Without Screening
n=106 Participants
Control group where patients did not receive a clinician applied social needs assessment as a standard of care
|
Control Group - With Screening
n=19 Participants
Control group where patients did receive social needs assessment as a standard of care without provider's access to the EHR-based CDS tool
|
|---|---|---|---|---|
|
Number of Emergency Department Events
Number of emergency department visits at 12 months follow-up
|
0.93 events
Standard Deviation 1.53
|
2.77 events
Standard Deviation 4.56
|
1.85 events
Standard Deviation 6.4
|
1.77 events
Standard Deviation 2.09
|
|
Number of Emergency Department Events
Number of emergency department visits at 24 months follow-up
|
1.09 events
Standard Deviation 2.41
|
3.28 events
Standard Deviation 6.69
|
3.59 events
Standard Deviation 16.51
|
1.09 events
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 12 and 24 months follow-upNumber of unplanned hospitalization
Outcome measures
| Measure |
Intervention Group - Without Screening
n=62 Participants
Patients in the intervention group where information provided in the EHR-based CDS tool (e.g., the calculated social risk score) suggested that the patient did not require an additional social needs assessment
|
Intervention Group - With Screening
n=64 Participants
Patients in the intervention group where the information provided in the CDS tool (e.g., a high social risk score) suggested that high social needs may be present
|
Control Group - Without Screening
n=106 Participants
Control group where patients did not receive a clinician applied social needs assessment as a standard of care
|
Control Group - With Screening
n=19 Participants
Control group where patients did receive social needs assessment as a standard of care without provider's access to the EHR-based CDS tool
|
|---|---|---|---|---|
|
Number of Hospitalization Events
Number of Hospitalization Events at 12 months follow-up
|
0.19 events
Standard Deviation 0.60
|
0.7 events
Standard Deviation 1.87
|
0.52 events
Standard Deviation 1.57
|
0.29 events
Standard Deviation 0.73
|
|
Number of Hospitalization Events
Number of Hospitalization Events at 24 months follow-up
|
0.17 events
Standard Deviation 0.60
|
0.69 events
Standard Deviation 1.48
|
0.55 events
Standard Deviation 1.78
|
0.15 events
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: From baseline to the end of follow up period (24 months)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.
Outcome measures
| Measure |
Intervention Group - Without Screening
n=62 Participants
Patients in the intervention group where information provided in the EHR-based CDS tool (e.g., the calculated social risk score) suggested that the patient did not require an additional social needs assessment
|
Intervention Group - With Screening
n=64 Participants
Patients in the intervention group where the information provided in the CDS tool (e.g., a high social risk score) suggested that high social needs may be present
|
Control Group - Without Screening
n=106 Participants
Control group where patients did not receive a clinician applied social needs assessment as a standard of care
|
Control Group - With Screening
n=19 Participants
Control group where patients did receive social needs assessment as a standard of care without provider's access to the EHR-based CDS tool
|
|---|---|---|---|---|
|
Number of Resolved Social Needs
Number of social needs at baseline
|
0 social needs
Interval 0.0 to 0.0
|
2.00 social needs
Interval 1.0 to 4.0
|
0 social needs
Interval 0.0 to 0.0
|
2.00 social needs
Interval 1.0 to 3.0
|
|
Number of Resolved Social Needs
Number of social needs resolved at the last follow-up
|
0.00 social needs
Interval 0.0 to 3.0
|
3.00 social needs
Interval 2.0 to 4.0
|
2.50 social needs
Interval 1.5 to 3.0
|
2.00 social needs
Interval 1.5 to 3.0
|
|
Number of Resolved Social Needs
Number of social needs from baseline to the last follow-up
|
3.00 social needs
Interval 3.0 to 3.0
|
3.00 social needs
Interval 3.0 to 5.0
|
3.00 social needs
Interval 2.75 to 3.25
|
3.00 social needs
Interval 2.0 to 4.0
|
Adverse Events
Intervention Group - Without Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group - With Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Without Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - With Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place