Emergency Service, HospitalNCT06655974
Predictive Modeling for Social Needs in Emergency Department Settings
A study testing Health-related social needs decision support system in people with Emergency Service, Hospital and Social Determinants of Health, run by Indiana University at 1 site in United States.
Trial summary
The overall objective of this study is to support emergency department management of patients' health-related social needs. This study will measure the impact of a decision support system that informs clinicians about which patients are likely to screen positive for a health-related social need. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Service, Hospital, Social Determinants of Health
- What is being tested?
- Health-related social needs decision support system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518,512 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults (>18 years old)
- Seeking care at Indianapolis, Indiana area emergency departments (EDs).
Who cannot join
- Children
- Encounters by patients that present with a critical illness/injury (e.g. severe trauma patients or those with Emergency Severity Index (ESI) classification level 1)
- Encounters by patients who have been transferred from another inpatient facility
- Patients that die during the ED encounter
- Encounters among patients who were ultimately admitted during their ED visits from our analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health
Indianapolis, Indiana, 46202
About this study
Official title: Protocol for Evaluating the Effectiveness of a Clinical Decision Support System With Prediction Modeling to Identify Patients With Health-related Social Needs in the Emergency Department
The overall objective of this study is to support emergency department management of patients' health-related social needs. This study will measure the impact of a decision support system that informs clinicians about which patients are likely to screen positive for a health-related social need. The system uses statistical models to create a health-related social need risk score for each patient. The main questions, the study aims to answer are:
- Does providing emergency department clinicians with risk scores on health-related social needs increase screening and referral activities?
- Does providing emergency department clinicians with risk scores on health-related social needs change patients' use of healthcare services?
The decision support system with health-related social needs risk scores will be introduced for all adult patients at one emergency department. Screening rates, referrals, and subsequent healthcare encounters will be compared with emergency departments that did not have access to the decision support system.
- Being tested
- Health-related social needs decision support system
- Keywords
- informatics
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-related social needs decision support systemOther
The clinical decision support intervention will present emergency department clinicians at an Indianapolis, IN ED with a likelihood score for an adult patient screening positive for the following health-related social needs (HRSNs): housing instability, food insecurity, transportation barriers, financial strain, and history of legal involvement. For each HRSN, the likelihood of screening positive is reported as "high", "medium", or "low". These categorizations are the product of logistic regression models. The clinical decision support intervention will be delivered through an existing FHIR (Fast Healthcare Interoperability Resources) standards-based clinical decision support platform.
| Study group | Role | What they receive |
|---|---|---|
| Decision support intervention group | Experimental | Adult ED patients seeking care the ED site with the health-related social needs decision support system live. Receives: Other: Health-related social needs decision support system |
| Comparison group | No intervention | Adult ED patients created using statistical matching from ED sites in the same metropolitan area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of emergency department encounters screened for health-related social needs (HRSNs)
The numerator will be an emergency department encounter with any indication of HRSN screening using any tool or questionnaire, regardless of patient completion or results. The denominator will be all eligible ED encounters.
Measured: At time of emergency department encounter (or within 24 hours)
Percent of emergency department encounters that were referred for health-related social needs (HRSNs) services
The numerator will be emergency department encounters with a referral to social worker, case management, community health workers, or related services within 24 hours of the ED encounter. The denominator will be all eligible ED encounters
Measured: At time of emergency department encounter (or within 24 hours)
Secondary outcomes (4)
Percent of encounters with an emergency department revisit measured at 3 days
The numerator will be an emergency department encounter at any facility included in the Indiana for Network Care database within 3 days of an ED encounter at an intervention or comparator site. ED revisits may serve as the index visit for subsequent revisits. The denominator will be all eligible ED encounters. Encounters resulting in an inpatient admission will be excluded from the numerator and denominator.
Measured: within 3 days of emergency department encounter
Percent of encounters with an emergency department revisit measured at 7 days
The numerator will be an emergency department encounter at any facility included in the Indiana for Network Care database within 7 days of an ED encounter at an intervention or comparator site. ED revisits may serve as the index visit for subsequent revisits. The denominator will be all eligible ED encounters. Encounters resulting in an inpatient admission will be excluded from the numerator and denominator.
Measured: within 7 days of emergency department encounter
Percent of encounters with an emergency department revisit measured at 30 days
The numerator will be an emergency department encounter at any facility included in the Indiana for Network Care database within 30 days of an ED encounter at an intervention or comparator site. ED revisits may serve as the index visit for subsequent revisits. The denominator will be all eligible ED encounters. Encounters resulting in an inpatient admission will be excluded from the numerator and denominator
Measured: within 30 days of emergency department encounter
Percent of emergency department encounters with primary care visit within 7 days of an ED encounter
The numerator will include all emergency department encounters with a completed family medicine, internal medicine, OBGYN, or geriatrician visit64 within 7 days of the ED visit. The denominator will be all eligible ED encounters. Encounters resulting in an inpatient admission will be excluded from the numerator and denominator.
Measured: within 7 days of emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start10 Mar 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergency Service, HospitalStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be at the ED level using a pre-post design with a matched comparison group.
- Masking
- None (open label)
- Enrolment
- 518,512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua R. Vest, PhD, Indiana University
- Investigators
- Joshua R Vest, PhD,MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655974
- Sponsor's protocol ID
- 2011558232
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data produced during the project will be preserved, but raw and derived data (at the patient-level) will not be posted publicly because of our use of secondary data from privately held electronic health record and health information exchange systems. Due to the data use restrictions put in place by consortium agreements among the health system partners that contribute EHR data to the Indiana Network for Patient Care, patient-level data cannot be shared or disseminated outside this project. However, de-identified derived data (at the patient-level) used in this study may be shared with investigators whose formal request is approved by the data owners. Requests can be sent to askRDS@regenstrief.org. Access to these data requires investigator support for use and a signed data access agreement between the Regenstrief Institute and the investigator's institution.
Publications
Mazurenko O, Hirsh AT, Harle CA, McNamee C, Vest JR. Acceptance of Automated Social Risk Scoring in the Emergency Department: Clinician, Staff, and Patient Perspectives. West J Emerg Med. 2024 Jul;25(4):614-623. doi: 10.5811/westjem.18577.
PubMed 39028248Mazurenko O, Harle CA, Blackburn J, Menachemi N, Hirsh A, Grannis S, Boustani M, Musey PI Jr, Schleyer TK, Sanner LM, Vest JR. Effectiveness of a clinical decision support system with prediction modeling to identify patients with health-related social needs in the emergency department: Study protocol. PLoS One. 2025 May 12;20(5):e0323094. doi: 10.1371/journal.pone.0323094. eCollection 2025.
PubMed 40354398
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Evaluating the Effectiveness of a Clinical Decision Support System With Prediction Modeling to Identify Patients With Health-related Social Needs in the Emergency Department
- ClinicalTrials.gov ID
- NCT06655974
- Acronym / sponsor ID
- 2011558232
- Keywords
- informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518,512 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to support emergency department management of patients' health-related social needs. This study will measure the impact of a decision support system that informs clinicians about which patients are likely to screen positive for a health-related social need. The system uses statistical models to create a health-related social need risk score for each patient. The main questions, the study aims to answer are:
- Does providing emergency department clinicians with risk scores on health-related social needs increase screening and referral activities?
- Does providing emergency department clinicians with risk scores on health-related social needs change patients' use of healthcare services?
The decision support system with health-related social needs risk scores will be introduced for all adult patients at one emergency department. Screening rates, referrals, and subsequent healthcare encounters will be compared with emergency departments that did not have access to the decision support system.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be at the ED level using a pre-post design with a matched comparison group.
| Arm | Type | Receives |
|---|---|---|
| Decision support intervention group | Experimental | Other: Health-related social needs decision support systemAdult ED patients seeking care the ED site with the health-related social needs decision support system live. |
| Comparison group | No intervention | –Adult ED patients created using statistical matching from ED sites in the same metropolitan area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (>18 years old)
- Seeking care at Indianapolis, Indiana area emergency departments (EDs).
Key exclusion criteria (5 listed)
- Children
- Encounters by patients that present with a critical illness/injury (e.g. severe trauma patients or those with Emergency Severity Index (ESI) classification level 1)
- Encounters by patients who have been transferred from another inpatient facility
- Patients that die during the ED encounter
- Encounters among patients who were ultimately admitted during their ED visits from our analysis
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 |
|---|---|---|
| Health-related social needs decision support systemThe clinical decision support intervention will present emergency department clinicians at an Indianapolis, IN ED with a likelihood score for an adult patient screening positive for the following health-related social needs (HRSNs): housing instability, food insecurity, transportation barriers, financial strain, and history of legal involvement. For each HRSN, the likelihood of screening positive is reported as "high", "medium", or "low". These categorizations are the product of logistic regression models. The clinical decision support intervention will be delivered through an existing FHIR (Fast Healthcare Interoperability Resources) standards-based clinical decision support platform. | Other | Decision support intervention group |
Primary outcome
Percent of emergency department encounters screened for health-related social needs (HRSNs)
Time frame: At time of emergency department encounter (or within 24 hours)
The numerator will be an emergency department encounter with any indication of HRSN screening using any tool or questionnaire, regardless of patient completion or results. The denominator will be all eligible ED encounters.
Percent of emergency department encounters that were referred for health-related social needs (HRSNs) services
Time frame: At time of emergency department encounter (or within 24 hours)
The numerator will be emergency department encounters with a referral to social worker, case management, community health workers, or related services within 24 hours of the ED encounter. The denominator will be all eligible ED encounters
4 secondary outcomes
Percent of encounters with an emergency department revisit measured at 3 days
Time frame: within 3 days of emergency department encounter
Percent of encounters with an emergency department revisit measured at 7 days
Time frame: within 7 days of emergency department encounter
Percent of encounters with an emergency department revisit measured at 30 days
Time frame: within 30 days of emergency department encounter
Percent of emergency department encounters with primary care visit within 7 days of an ED encounter
Time frame: within 7 days of emergency department visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 39028248Mazurenko O, Hirsh AT, Harle CA, McNamee C, Vest JR. Acceptance of Automated Social Risk Scoring in the Emergency Department: Clinician, Staff, and Patient Perspectives. West J Emerg Med. 2024 Jul;25(4):614-623. doi: 10.5811/westjem.18577.
- Derived from this study: PubMed 40354398Mazurenko O, Harle CA, Blackburn J, Menachemi N, Hirsh A, Grannis S, Boustani M, Musey PI Jr, Schleyer TK, Sanner LM, Vest JR. Effectiveness of a clinical decision support system with prediction modeling to identify patients with health-related social needs in the emergency department: Study protocol. PLoS One. 2025 May 12;20(5):e0323094. doi: 10.1371/journal.pone.0323094. eCollection 2025.
- Individual participant dataSharing planned: No. All data produced during the project will be preserved, but raw and derived data (at the patient-level) will not be posted publicly because of our use of secondary data from privately held electronic health record and health information exchange systems. Due to the data use restrictions put in place by consortium agreements among the health system partners that contribute EHR data to the Indiana Network for Patient Care, patient-level data cannot be shared or disseminated outside this project. However, de-identified derived data (at the patient-level) used in this study may be shared with investigators whose formal request is approved by the data owners. Requests can be sent to askRDS@regenstrief.org. Access to these data requires investigator support for use and a signed data access agreement between the Regenstrief Institute and the investigator's institution.
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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.
Joshua R Vest, PhD,MPH principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-related social needs decision support system in people with Emergency Service, Hospital and Social Determinants of Health, run by Indiana University at 1 site 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 2 inclusion and 5 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of emergency department encounters screened for health-related social needs (HRSNs) (time frame: At time of emergency department encounter (or within 24 hours)). The study lists 2 primary outcomes in all. 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 NCT06655974, 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 31 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.