Predictive Modeling for Social Needs in Emergency Department Settings

March 26, 2026 updated by: Joshua R. Vest, PhD, Indiana University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

518512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decision support intervention group
Adult ED patients seeking care the ED site with the health-related social needs decision support system live.
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.
No Intervention: Comparison group
Adult ED patients created using statistical matching from ED sites in the same metropolitan area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
At time of emergency department encounter (or within 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of encounters with an emergency department revisit measured at 3 days
Time Frame: within 3 days of emergency department encounter
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.
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
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.
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
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
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
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.
within 7 days of emergency department visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of emergency department encounters where the health-related social needs (HRSN) decision support system intervention was accessed.
Time Frame: At time of emergency department encounter (or within 24 hours)
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.
At time of emergency department encounter (or within 24 hours)
Percent of emergency department encounters where the clinical decision support platform was accessed
Time Frame: At time of emergency department encounter(or within 24 hours)
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
At time of emergency department encounter(or within 24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joshua R Vest, PhD,MPH, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011558232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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