NCT03805126

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

January 11, 2019

Last Update Submit

November 4, 2020

Conditions

Health-harming Legal Needs

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (28)

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale

    baseline

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale

    3 months

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale

    6 months

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale

    12 months

  • Depression as assessed by the Center for Epidemiologic Studies Depression Scale

    baseline

  • +23 more secondary outcomes

Study Arms (2)

Medical Legal Partnership

EXPERIMENTAL

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 PartnershipBehavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

Usual care includes consultation with a social worker and a community health worker.

Behavioral: Usual Care

Interventions

Medical Legal PartnershipBEHAVIORAL

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.

Medical Legal Partnership
Usual CareBEHAVIORAL

Usual care includes consultation with a social worker and a community health worker.

Medical Legal PartnershipUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level)
  • individuals with HHLNs
  • English or Spanish speaking

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jensen Clinic

Houston, Texas, 77093, United States

Location

Related Publications (1)

  • Liaw W, Northrup TF, Stotts AL, Bakos-Block C, Suchting R, Chen A, Hernandez A, Finzetto L, Green C, Murphy T. Medical-Legal Partnership Effects on Mental Health, Health Care Use, and Quality of Life in Primary Care: A Randomized Clinical Trial. J Am Board Fam Med. 2023 May 8;36(3):414-424. doi: 10.3122/jabfm.2022.220349R1. Epub 2023 Apr 7.

    PMID: 37028914DERIVED

Study Officials

  • Winston Liaw, MD, MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

February 14, 2019

Primary Completion

September 11, 2020

Study Completion

September 11, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)