<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805126</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-18-1037</org_study_id>
    <nct_id>NCT03805126</nct_id>
  </id_info>
  <brief_title>Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals</brief_title>
  <official_title>Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas Medical Center Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>William Marsh Rice University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to test whether participation of low-income patients with&#xD;
      health-harming legal needs (HHLNs) in a medical legal partnership (MLP) results in improved&#xD;
      mental health, improved quality of life, reduced utilization, and increased resolution of&#xD;
      HHLNs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">September 11, 2020</completion_date>
  <primary_completion_date type="Actual">September 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress as assessed by the Perceived Stress Scale</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress as assessed by the Perceived Stress Scale</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress as assessed by the Perceived Stress Scale</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress as assessed by the Perceived Stress Scale</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as assessed by the Center for Epidemiologic Studies Depression Scale</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as assessed by the Center for Epidemiologic Studies Depression Scale</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as assessed by the Center for Epidemiologic Studies Depression Scale</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as assessed by the Center for Epidemiologic Studies Depression Scale</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Urgent Care Visits</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Urgent Care Visits</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Urgent Care Visits</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Urgent Care Visits</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Emergency Department Visits</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Emergency Department Visits</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Emergency Department Visits</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Emergency Department Visits</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Visits</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Visits</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Visits</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Visits</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of baseline health-harming legal needs that were resolved</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of baseline health-harming legal needs that were resolved</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of baseline health-harming legal needs that were resolved</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of baseline health-harming legal needs that were resolved</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Health-harming Legal Needs</condition>
  <arm_group>
    <arm_group_label>Medical Legal Partnership</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care includes consultation with a social worker and a community health worker.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical Legal Partnership</intervention_name>
    <description>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.</description>
    <arm_group_label>Medical Legal Partnership</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual care includes consultation with a social worker and a community health worker.</description>
    <arm_group_label>Medical Legal Partnership</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  low-income individuals (Low-income is defined as earning less than 200% of the Federal&#xD;
             Poverty Level)&#xD;
&#xD;
          -  individuals with HHLNs&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self-identified as being at significant and immediate risk due to HHLNs (e.g., a&#xD;
             situation that involves imminent risk to the patient such as domestic violence)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Winston Liaw, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jensen Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Winston Liaw</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805126
org study id: HSC-MS-18-1037
nct id: NCT03805126
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Stress as assessed by the Perceived Stress Scale
time frame: baseline
description: 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.
measure: Stress as assessed by the Perceived Stress Scale
time frame: 3 months
description: 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.
measure: Stress as assessed by the Perceived Stress Scale
time frame: 6 months
description: 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.
measure: Stress as assessed by the Perceived Stress Scale
time frame: 12 months
description: 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.
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
time frame: baseline
description: 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.
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
time frame: 3 months
description: 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.
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
time frame: 6 months
description: 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.
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
time frame: 12 months
description: 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.
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale
time frame: baseline
description: 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.
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale
time frame: 3 months
description: 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.
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale
time frame: 6 months
description: 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.
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale
time frame: 12 months
description: 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.
measure: Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
time frame: baseline
description: 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.
measure: Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
time frame: 3 months
description: 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.
measure: Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
time frame: 6 months
description: 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.
measure: Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
time frame: 12 months
description: 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.
measure: Number of Urgent Care Visits
time frame: baseline
measure: Number of Urgent Care Visits
time frame: 3 months
measure: Number of Urgent Care Visits
time frame: 6 months
measure: Number of Urgent Care Visits
time frame: 12 months
measure: Number of Emergency Department Visits
time frame: baseline
measure: Number of Emergency Department Visits
time frame: 3 months
measure: Number of Emergency Department Visits
time frame: 6 months
measure: Number of Emergency Department Visits
time frame: 12 months
measure: Number of Hospital Visits
time frame: baseline
measure: Number of Hospital Visits
time frame: 3 months
measure: Number of Hospital Visits
time frame: 6 months
measure: Number of Hospital Visits
time frame: 12 months
measure: Percentage of baseline health-harming legal needs that were resolved
time frame: baseline
measure: Percentage of baseline health-harming legal needs that were resolved
time frame: 3 months
measure: Percentage of baseline health-harming legal needs that were resolved
time frame: 6 months
measure: Percentage of baseline health-harming legal needs that were resolved
time frame: 12 months
arm group label: Medical Legal Partnership
arm group type: Experimental
description: 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.
arm group label: Usual Care
arm group type: Active Comparator
description: Usual care includes consultation with a social worker and a community health worker.
intervention type: Behavioral
intervention name: Medical Legal Partnership
description: 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.
arm group label: Medical Legal Partnership
intervention type: Behavioral
intervention name: Usual Care
description: Usual care includes consultation with a social worker and a community health worker.
arm group label: Medical Legal Partnership
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Winston Liaw, MD, MPH
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Winston Liaw
investigator title: Associate professor
sharing ipd: No