NCT06655974

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518,512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

August 23, 2024

Last Update Submit

March 26, 2026

Conditions

Keywords

informatics

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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

    within 3 days of emergency department encounter

  • Percent of encounters with an emergency department revisit measured at 7 days

    within 7 days of emergency department encounter

  • Percent of encounters with an emergency department revisit measured at 30 days

    within 30 days of emergency department encounter

  • Percent of emergency department encounters with primary care visit within 7 days of an ED encounter

    within 7 days of emergency department visit

Other Outcomes (2)

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

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

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

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

Study Arms (2)

Decision support intervention group

EXPERIMENTAL

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

Comparison group

NO INTERVENTION

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

Interventions

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.

Decision support intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • 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.

    PMID: 39028248BACKGROUND
  • 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.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joshua R Vest, PhD,MPH

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The intervention will be at the ED level using a pre-post design with a matched comparison group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2024

First Posted

October 24, 2024

Study Start

March 10, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations