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CompletedNCT06655974Updated Mar 31, 2026

Predictive Modeling for Social Needs in Emergency Department Settings

An interventional study of Health-related social needs decision support system in Emergency Service, Hospital and Social Determinants of Health, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Indiana University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
518,512
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Emergency Service, Hospital
  • Social Determinants of Health

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Keywords

  • informatics
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 518,512 is above the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults (>18 years old)
  • Seeking care at Indianapolis, Indiana area emergency departments (EDs).

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
518,512 participants (actual)

Study arms

  • Experimental
    Decision support intervention group

    Adult ED patients seeking care the ED site with the health-related social needs decision support system live.

    Other: Health-related social needs decision support system

  • No intervention
    Comparison group

    Adult ED patients created using statistical matching from ED sites in the same metropolitan area.

Interventions

  • OtherHealth-related social needs decision support system

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At time of emergency department encounter (or within 24 hours)

  2. 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

    Time frame: At time of emergency department encounter (or within 24 hours)

Secondary outcomes

  1. 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.

    Time frame: within 3 days of emergency department encounter

  2. 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.

    Time frame: within 7 days of emergency department encounter

  3. 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

    Time frame: within 30 days of emergency department encounter

  4. 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.

    Time frame: within 7 days of emergency department visit

Other outcomes

  1. Percent of emergency department encounters where the health-related social needs (HRSN) decision support system intervention was accessed.

    The numerator will include encounters with access of the social needs section (containing the risk prediction scores) of the decision support system intervention during the study visit (defined as within 24 hours). Access will be defined as record of the end user visiting the HRSN page in the system user logs. The denominator will be all eligible ED encounters. Limited to the intervention site only.

    Time frame: At time of emergency department encounter (or within 24 hours)

  2. Percent of emergency department encounters where the clinical decision support platform was accessed

    The numerator will include encounters with access of clinical decision support platform during the study visit (defined as within 24 hours). Access will be defined as record of the end user visiting initiating a request to the decision support application from the EHR. Any portion of the decision support platform (not just the health-related social needs section) is included. The denominator will be all eligible ED encounters (see Inclusion criteria, above). Limited to the intervention site only

    Time frame: At time of emergency department encounter(or within 24 hours)

07

Study locations

1 site
  • Indiana University Health
    Indianapolis, Indiana 46202, United States
08

References and documents

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 39028248 ↗
  • Mazurenko 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06655974
Lead sponsor
Indiana University
Responsible party
Joshua R. Vest, PhD (Professor, Indiana University) — Principal investigator
First posted
Oct 24, 2024
Start date
Mar 10, 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
Mar 31, 2026

Study contacts

Joshua R Vest, PhD,MPH
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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