Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals

Study Overview
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Brief Summary
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The aim of this study is to test whether participation of low-income patients with health-harming legal needs (HHLNs) in a medical legal partnership (MLP) results in improved mental health, improved quality of life, reduced utilization, and increased resolution of HHLNs.

Official Title
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Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals

Conditions
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Health-harming Legal Needs

Intervention / Treatment
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* Behavioral: Medical Legal Partnership
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level) individuals with HHLNs English or Spanish speaking Exclusion Criteria: self-identified as being at significant and immediate risk due to HHLNs (e.g., a situation that involves imminent risk to the patient such as domestic violence)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Legal Partnership<br>With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs). This arm will also receive usual care, which includes consultation with a social worker and a community health worker. | Behavioral: Medical Legal Partnership<br>* With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs). This arm will also receive usual care, which includes consultation with a social worker and a community health worker.<br>Behavioral: Usual Care<br>* Usual care includes consultation with a social worker and a community health worker.<br>|
| Active Comparator: Usual Care<br>Usual care includes consultation with a social worker and a community health worker. | Behavioral: Usual Care<br>* Usual care includes consultation with a social worker and a community health worker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress as assessed by the Perceived Stress Scale | The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40. A higher score indicates a worse outcome. | baseline | 
| Stress as assessed by the Perceived Stress Scale | The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40. A higher score indicates a worse outcome. | 3 months | 
| Stress as assessed by the Perceived Stress Scale | The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40. A higher score indicates a worse outcome. | 6 months | 
| Stress as assessed by the Perceived Stress Scale | The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40. A higher score indicates a worse outcome. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale | The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21. A higher score indicates a worse outcome. | baseline | 
| Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale | The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21. A higher score indicates a worse outcome. | 3 months | 
| Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale | The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21. A higher score indicates a worse outcome. | 6 months | 
| Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale | The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21. A higher score indicates a worse outcome. | 12 months | 
| Depression as assessed by the Center for Epidemiologic Studies Depression Scale | The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60. A higher score indicates a worse outcome. | baseline | 
| Depression as assessed by the Center for Epidemiologic Studies Depression Scale | The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60. A higher score indicates a worse outcome. | 3 months | 
| Depression as assessed by the Center for Epidemiologic Studies Depression Scale | The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60. A higher score indicates a worse outcome. | 6 months | 
| Depression as assessed by the Center for Epidemiologic Studies Depression Scale | The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60. A higher score indicates a worse outcome. | 12 months | 
| Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150. A higher score indicates a worse outcome. | baseline | 
| Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150. A higher score indicates a worse outcome. | 3 months | 
| Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150. A higher score indicates a worse outcome. | 6 months | 
| Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150. A higher score indicates a worse outcome. | 12 months | 
| Number of Urgent Care Visits |  | baseline | 
| Number of Urgent Care Visits |  | 3 months | 
| Number of Urgent Care Visits |  | 6 months | 
| Number of Urgent Care Visits |  | 12 months | 
| Number of Emergency Department Visits |  | baseline | 
| Number of Emergency Department Visits |  | 3 months | 
| Number of Emergency Department Visits |  | 6 months | 
| Number of Emergency Department Visits |  | 12 months | 
| Number of Hospital Visits |  | baseline | 
| Number of Hospital Visits |  | 3 months | 
| Number of Hospital Visits |  | 6 months | 
| Number of Hospital Visits |  | 12 months | 
| Percentage of baseline health-harming legal needs that were resolved |  | baseline | 
| Percentage of baseline health-harming legal needs that were resolved |  | 3 months | 
| Percentage of baseline health-harming legal needs that were resolved |  | 6 months | 
| Percentage of baseline health-harming legal needs that were resolved |  | 12 months |