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

February 10, 2025 updated by: Miguel Muñoz-Laboy, Stony Brook University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Global Health-10
Time Frame: 1) 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.
1) baseline (point of contact with patient); 2) 3-month, 3) 6- month, 4) and 12-month follow ups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

Boston University
University of Puerto Rico
University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AWD00003786

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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