NCT06913049

Brief Summary

The goal of this clinical trial is to determine if artificial intelligence and machine learning (AI/ML) models can help address social needs in Medicaid enrollees. The main questions it aims to answer are: Can AI/ML models accurately identify social needs from administrative healthcare data? Can AI/ML models accurately predict which people will engage with social supports? Researchers will compare individuals who live in different regions to see if AI/ML models perform better than the status quo.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
249,660

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Apr 2029

First Submitted

Initial submission to the registry

March 25, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

March 25, 2025

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the prevalence of Health Related Social Needs (HRSNs) as assessed by the Maryland Department of Health HRSN Screening Tool

    We will analyze social screening results from individuals in the treatment arm to determine if our system leads to the assessment of individuals with a higher social need profile.

    From enrollment to 12 months.

Secondary Outcomes (1)

  • Change in the proportion of participants who receive social services who have a health-related social need

    From enrollment to 12 months.

Study Arms (2)

SESS - Treatment

EXPERIMENTAL

This arm will receive care coordination resources supported by our Social Engagement Support System, including the triage of screening outreach based on predicted risk of an unmet social need and engagement support to decrease like likelihood of dropout from the social services workflow.

Other: Social Engagement Support System

SESS - Control

NO INTERVENTION

This arm will receive no intervention.

Interventions

In this protocol, we will develop and deploy a set of machine learning models that use multiple individual- and community-level data sources to predict which members use the emergency department to fulfill social or non-urgent needs as opposed to treatment for urgent medical conditions. These models will identify individuals whose social needs are driving inappropriate utilization so that high-risk individuals will be given enhanced outreach services to facilitate completion of a comprehensive social needs assessment. We will also develop and deploy an engagement support system that identifies and displays the characteristics of members that prevent them from engaging with a Community Based Organization (CBO). This system will use artificial intelligence techniques to identify characteristics of individuals who have historically disengaged from the social service pipeline before receiving social services and suggest potential strategies for increasing engagement.

SESS - Treatment

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Members of partner health plan aged 18-64

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore County

Baltimore, Maryland, 21250, United States

Location

Central Study Contacts

Ian Stockwell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 6, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

April 6, 2025

Record last verified: 2025-02

Locations