Health Harming Legal NeedsNCT06532487
Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities
A study testing Critical Time Medical-Legal Partnership Intervention in people with Health Harming Legal Needs, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Harming Legal Needs
- What is being tested?
- Critical Time Medical-Legal Partnership Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2024to Jun 2027
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Betances Health Center
New York, New York, 10002
Miguel A Munoz-Laboy, 646-245-1872, miguel.munoz-laboy@stonybrook.edu
About this study
This clinical trial will examine the effects of legal services on primary care outcomes for medically underserved communities.
The aims of the study are:
Read more
- To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership (CTI-MLP) on patient outcomes.
- To determine the most efficient mechanisms for CTI-MLP delivery.
- 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.
Read the 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
- Being tested
- Critical Time Medical-Legal Partnership Intervention
- Keywords
- medical-legal partnerships, health harming legal needs, medically underserved communities, Latinx communities, Migrant communities, FQHC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Time Medical-Legal Partnership InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Critical Time Medical-Legal Partnership Intervention | Experimental | 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. Receives: Other: Critical Time Medical-Legal Partnership Intervention |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Global Health-10
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.
Measured: 1) baseline (point of contact with patient); 2) 3-month, 3) 6- month, 4) and 12-month follow ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start28 Nov 2024
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Harming Legal NeedsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type II effectiveness-implementation trial with a cluster randomized design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Florida, Boston University, University of Puerto Rico
- Responsible party
- Principal investigator, Miguel Muñoz-Laboy, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532487
- Sponsor's protocol ID
- AWD00003786
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities
- ClinicalTrials.gov ID
- NCT06532487
- Acronym / sponsor ID
- AWD00003786
- Conditions
- Health Harming Legal Needs
- Keywords
- medical-legal partnerships, health harming legal needs, medically underserved communities, Latinx communities, Migrant communities, FQHC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- University of Central Florida, Boston University, University of Puerto Rico
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Aug 2024 (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.
This clinical trial will examine the effects of legal services on primary care outcomes for medically underserved communities.
The aims of the study are:
- To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership (CTI-MLP) on patient outcomes.
- To determine the most efficient mechanisms for CTI-MLP delivery.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Hybrid type II effectiveness-implementation trial with a cluster randomized design.
| Arm | Type | Receives |
|---|---|---|
| Critical Time Medical-Legal Partnership Intervention | Experimental | Other: Critical Time Medical-Legal Partnership InterventionPatients 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Critical Time Medical-Legal Partnership InterventionUtilizing 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. | Other | Critical Time Medical-Legal Partnership Intervention |
Primary outcome
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.
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 12 Feb 2025.
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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 Critical Time Medical-Legal Partnership Intervention in people with Health Harming Legal Needs, run by Stony Brook University 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Miguel A Munoz-Laboy, DrPH (6462451872, miguel.munoz-laboy@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). 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 12 Feb 2025.