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

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.

Study Overview

• Status: Completed
• Conditions: Health-harming Legal Needs
• Intervention / Treatment: Behavioral: Medical Legal Partnership; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77093
      • Jensen Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Legal Partnership; 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; 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: Usual Care; Usual care includes consultation with a social worker and a community health worker.
Active Comparator: Usual Care; Usual care includes consultation with a social worker and a community health worker.	Behavioral: Usual Care; Usual care includes consultation with a social worker and a community health worker.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: University of Houston; William Marsh Rice University; Texas Medical Center Foundation
• Investigators: Principal Investigator: Winston Liaw, MD, MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): September 11, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-18-1037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No