- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913049
The Development, Implementation, and Evaluation of a Social Engagement Support System
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Social drivers of health (SDoH) are the largest factors affecting our health and wellbeing but are difficult for healthcare systems to address. Despite new models that provide incentives for health plans and providers to reach beyond clinical care to improve patient health outcomes, existing data infrastructures lack relevant information to support such interventions. The first problem is one of identification; providers undercode social needs in existing schemas and ancillary data collection methods such as social screens are not common, standardized, or easily shared. The second problem is a lack of engagement between individuals and social services, which is especially frustrating since there are many evidence-based practices that community-based organizations (CBOs) use to address social needs. Without precise information on who needs social support and how to maximize their engagement with CBOs, providers and insurers have limited ability to deploy interventions that remove barriers to care and equalize health outcomes across vulnerable populations.
Our project will apply a precision medicine approach to the identification of, and engagement with, Medicaid recipients with social needs. The investigators have partnered with a managed care organization that coordinates benefits for over 250,000 Maryland Medicaid members. They have launched a population-wide social screening program to add member-reported social needs to their existing clinical data. The investigators will enhance their health information technology (IT) infrastructure with a set of machine learning models for risk identification, an engagement support system to maximize member's use of social supports, and a continuous qualitative and quantitative improvement process to establish a learning health system. We will accomplish this work through the following aims:
Aim 1: 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. The investigators will analyze these assessments to determine if our models lead to the assessment of individuals with a higher social need profile.
Aim 2: Develop and deploy an engagement support system that identifies and displays the characteristics of members that prevent them from engaging with a 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. The investigators will apply the models to newly assessed members and present predicted high risk individuals to the plan's community health workers through their existing IT platform, allowing them to proactively address members' barriers to accessing services. The investigators will analyze engagement success (i.e., whether a member who was referred to services received assistance from a CBO) to determine if our support system increased the likelihood of success.
Aim 3: Implement a continuous qualitative and quantitative improvement process that identifies recurring themes and disengagement points in cases where members were not able to complete their relevant social intervention. These findings will be analyzed by the research team to identify potential tactics to address engagement barriers, and resulting recommendations for increasing engagement will be propagated through the system either by updates to the health IT infrastructure or staff training sessions. Through this Aim the investigators will build a learning health system, with the team constantly refining engagement methods throughout the project.
The study team is well positioned to develop a social needs intervention protocol and will include rigorous evaluations to assess the effects of our intervention on the health and social outcomes of participating members by their demographic and geographic characteristics. Together, these aims will help inform the next generation of value-based care paradigms by identifying and addressing social needs and shrinking differences in health outcomes across a large, high-risk population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ian Stockwell, PhD
- Phone Number: 410-455-8424
- Email: istock1@umbc.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21250
- University of Maryland, Baltimore County
-
Contact:
- Ian Stockwell, PhD
- Phone Number: 410-455-8424
- Email: istock1@umbc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Members of partner health plan aged 18-64
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SESS - Treatment
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.
|
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.
|
|
No Intervention: SESS - Control
This arm will receive no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the prevalence of Health Related Social Needs (HRSNs) as assessed by the Maryland Department of Health HRSN Screening Tool
Time Frame: From enrollment to 12 months.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the proportion of participants who receive social services who have a health-related social need
Time Frame: From enrollment to 12 months.
|
We will analyze engagement success (i.e., whether a member who was referred to services received assistance from a CBO) using secondary data to determine if our support system increased the likelihood of success.
|
From enrollment to 12 months.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Kuali #1569
- 1R01MD019814-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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