Social Determinants of Health (SDOH)NCT06913049
The Development, Implementation, and Evaluation of a Social Engagement Support System
A study testing Social Engagement Support System in people with Social Determinants of Health (SDOH), run by University of Maryland, Baltimore County at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health (SDOH)
- What is being tested?
- Social Engagement Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249,660 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Members of partner health plan aged 18-64
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland, Baltimore County
Baltimore, Maryland, 21250
Ian Stockwell, PhD, 410-455-8424, istock1@umbc.edu
About this study
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.
Read the 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.
- Conditions
- Social Determinants of Health (SDOH)
- Being tested
- Social Engagement Support System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Engagement Support SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Social Engagement Support System |
| SESS - Control | No intervention | This arm will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From enrollment to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study startJun 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of Health (SDOH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 249,660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore County
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913049
- Sponsor's protocol ID
- Kuali #1569
- Other IDs
- 1R01MD019814-01
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data is protected under HIPAA and may be shared with appropriate data use agreements. This will be negotiated with partners as needed.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development, Implementation, and Evaluation of a Social Engagement Support System
- ClinicalTrials.gov ID
- NCT06913049
- Acronym / sponsor ID
- Kuali #1569
- Conditions
- Social Determinants of Health (SDOH)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 249,660 participants (estimated)
- Lead sponsor
- University of Maryland, Baltimore CountyUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SESS - Treatment | Experimental | Other: Social Engagement Support SystemThis 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. |
| SESS - Control | No intervention | –This arm will receive no intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Members of partner health plan aged 18-64
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Engagement Support SystemIn 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. | Other | SESS - Treatment |
Primary outcome
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.
1 secondary outcome
Change in the proportion of participants who receive social services who have a health-related social need
Time frame: From enrollment to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided. All data is protected under HIPAA and may be shared with appropriate data use agreements. This will be negotiated with partners as needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Engagement Support System in people with Social Determinants of Health (SDOH), run by University of Maryland, Baltimore County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Stockwell, PhD (410-455-8424, istock1@umbc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.