Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT06532487

Conditions

Health Harming Legal Needs

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

Critical Time Medical-Legal Partnership Intervention

Study Details

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.

Conditions

Health Harming Legal Needs

Study ID

NCT06532487

Start date

Nov 28, 2024

Status verified date

Feb, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

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 Design

Enrollment

1140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Miguel A Munoz-Laboy, DrPH

6462451872miguel.munoz-laboy@stonybrook.edu

Locations

Betances Health Center

Recruiting

New York, New York, United States, 10002

Contacts

Miguel A Munoz-Laboy

646-245-1872miguel.munoz-laboy@stonybrook.edu

More Information

Sponsor

Stony Brook University

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-02-12.