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

NCT ID: NCT06532487

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2027-06-30

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.

Conditions

Health Harming Legal Needs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Critical Time Medical-Legal Partnership Intervention

Patients receiving care at an intervention health center will (a) be screened for health-harming legal needs. Those who meet eligibility criteria will be offered the opportunity to meet with a lawyer to review and explain their legal risks, rights, and remedies, (b) will be provided direct legal representation to mitigate or eliminate those legal needs, and (c) will consent to tracking of legal case management activity and outcomes and health outcomes in ways that accord with patient autonomy/consent, study expectation.

Group Type: EXPERIMENTAL

Critical Time Medical-Legal Partnership Intervention

Intervention Type: OTHER

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.

Control

Patients receiving care at a health center in the control arm of the study in the control or "no intervention" arm of the study will (a) be screened for health-harming legal needs. Those who meet eligibility criteria will (b) be provided basic legal information and referral to legal aid, and (c) will consent to tracking of legal and health outcomes in ways that accord with patient autonomy/consent, study expectation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Critical 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Central Florida

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

University of Puerto Rico

OTHER

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Miguel Muñoz-Laboy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Betances Health Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Miguel A Munoz-Laboy, DrPH

Role: CONTACT

miguel.munoz-laboy@stonybrook.edu

6462451872

Facility Contacts

Miguel A Munoz-Laboy

Role: primary

miguel.munoz-laboy@stonybrook.edu

646-245-1872

Other Identifiers

AWD00003786

Identifier Type: -

Identifier Source: org_study_id