Skip to content

Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities

Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06532487
Enrollment
1140
Registered
2024-08-01
Start date
2024-11-28
Completion date
2027-06-30
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Harming Legal Needs

Keywords

medical-legal partnerships, health harming legal needs, medically underserved communities, Latinx communities, Migrant communities, FQHC

Brief summary

This clinical trial will examine the effects of legal services on primary care outcomes for medically underserved communities. The aims of the study are: 1. To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership (CTI-MLP) on patient outcomes. 2. To determine the most efficient mechanisms for CTI-MLP delivery. 3. To develop innovative community engagement strategies for addressing health-harming legal needs within community health centers. Eligible patients will be asked to complete a questionnaire 4 times, first when they join the study and then at 3 months, 6 months, and 12 months. In the survey, they will be asked to provide information about themselves, their health care, aspects of their daily life, and hardships they face. They will also allow researchers to access their electronic health record information housed in the community-based organization and attorney notes. Patient information will be completely confidential and de-identified, meaning, the research team will not know the identity of the person who answered the questions. Participating community health centers will be randomized (assigned by chance) to provide basic legal information and referral to legal aid; or have an attorney on-site to provide legal aid to those who screen for legal needs.

Detailed description

In this study, we proposed that providing legal services within primary care can enhance healthcare delivery efficiency by addressing legal needs (such as barriers to health insurance, medical treatments, housing safety, employment stability, and other legal needs) that can disrupt care to patients. The proposed study, led by researchers at Stony Brook University, Boston University, University of Central Florida (UCF), and the University of Puerto Rico in partnership with the National Center for Medical-Legal Partnerships, UCF School of Medicine's Implementation Science Lab, and six federally qualified health centers; will precisely examine the effects of legal services on primary care outcomes for medically underserved communities. We will conduct a hybrid type II effectiveness-implementation trial with a cluster randomized design in 6 federally qualified health centers (FQHCs) in Pennsylvania, New York, and Puerto Rico to test a Critical-time Intervention Medical-Legal Partnership (CTI-MLP) approach compared to the standard of care. Three FQHCs will receive a CTI-MLP approach that includes provision of legal aid and capacity building through team-facing legal support. The other three FQHCs will receive legal education and awareness, including information about community-based legal organizations. Over a 12-month period, the team will collect (1) patients' health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life; (2) data on legal needs and risk factors (3) longitudinal patient clinical outcomes (N=960); and (4) FQHC staff (N=180) and clinic-level indicators, including provider-patient communication and readiness for continued implementation and sustainability. We will assemble a Latinx and migrant community advisory board and a scientific advisory board with medical-legal partnership expertise. Active engagement will ensure the effective translation and dissemination of our findings into practice. With new Medicaid models emerging that offer reimbursement for some social care provision, state officials can also use data to consider expansion of Medicaid services to include the coordination and provision of social and legal services. Completion of this project will result in an innovative, evidence-based intervention package to improve health outcomes for highly vulnerable communities.

Interventions

OTHERCritical Time Medical-Legal Partnership Intervention

Utilizing a hybrid type II effectiveness-implementation trial with a cluster randomized design in six predominantly Latino-serving federally qualified health centers (FQHCs) in three major urban settings, we are examining whether integrating legal services into existing health clinics that serve Latinx and recent migrant communities can improve engagement in care and improve the health of Latinx/Hispanic and recent migrants.

Sponsors

University of Central Florida
CollaboratorOTHER
Boston University
CollaboratorOTHER
University of Puerto Rico
CollaboratorOTHER
Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Hybrid type II effectiveness-implementation trial with a cluster randomized design.

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients will be included in the trial if they meet all the following criteria: 1) ages 13 or older, 2) impacted by acute health-harming legal needs or risks (confirmed by screening developed in preparation for this proposal); 3) willing and able to consent to participate in the trial (including accessing EHR at the FQHC); and, 4) do not intend to relocate within the 12 months following their enrollment in the study.

Exclusion criteria

* Patients who do not meet the inclusion criteria will be excluded from the trial. Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 12 months from proposed enrollment in the study, will also be excluded from the trial.

Design outcomes

Primary

MeasureTime frameDescription
PROMIS Global Health-101) baseline (point of contact with patient); 2) 3-month, 3) 6- month, 4) and 12-month follow ups.PROMIS Global Health-10, a self-administered measured included in the survey described below. It includes general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.

Countries

United States

Contacts

Primary ContactMiguel A Munoz-Laboy, DrPH
miguel.munoz-laboy@stonybrook.edu6462451872

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026