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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03805126
Collaborator
Texas Medical Center Foundation (Other), University of Houston (Other), William Marsh Rice University (Other)
160
1
2
18.9
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Medical Legal Partnership
  • Behavioral: Usual Care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals
Actual Study Start Date :
Feb 14, 2019
Actual Primary Completion Date :
Sep 11, 2020
Actual Study Completion Date :
Sep 11, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Stress as assessed by the Perceived Stress Scale [baseline]

    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.

  2. Stress as assessed by the Perceived Stress Scale [3 months]

    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. Stress as assessed by the Perceived Stress Scale [6 months]

    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.

  4. Stress as assessed by the Perceived Stress Scale [12 months]

    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.

Secondary Outcome Measures

  1. Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale [baseline]

    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.

  2. Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale [3 months]

    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. Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale [6 months]

    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.

  4. Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale [12 months]

    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.

  5. Depression as assessed by the Center for Epidemiologic Studies Depression Scale [baseline]

    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. Depression as assessed by the Center for Epidemiologic Studies Depression Scale [3 months]

    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.

  7. Depression as assessed by the Center for Epidemiologic Studies Depression Scale [6 months]

    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.

  8. Depression as assessed by the Center for Epidemiologic Studies Depression Scale [12 months]

    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.

  9. Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [baseline]

    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.

  10. Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [3 months]

    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.

  11. Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [6 months]

    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. Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) [12 months]

    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.

  13. Number of Urgent Care Visits [baseline]

  14. Number of Urgent Care Visits [3 months]

  15. Number of Urgent Care Visits [6 months]

  16. Number of Urgent Care Visits [12 months]

  17. Number of Emergency Department Visits [baseline]

  18. Number of Emergency Department Visits [3 months]

  19. Number of Emergency Department Visits [6 months]

  20. Number of Emergency Department Visits [12 months]

  21. Number of Hospital Visits [baseline]

  22. Number of Hospital Visits [3 months]

  23. Number of Hospital Visits [6 months]

  24. Number of Hospital Visits [12 months]

  25. Percentage of baseline health-harming legal needs that were resolved [baseline]

  26. Percentage of baseline health-harming legal needs that were resolved [3 months]

  27. Percentage of baseline health-harming legal needs that were resolved [6 months]

  28. Percentage of baseline health-harming legal needs that were resolved [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jensen Clinic Houston Texas United States 77093

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston
  • Texas Medical Center Foundation
  • University of Houston
  • William Marsh Rice University

Investigators

  • Principal Investigator: Winston Liaw, MD, MPH, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Winston Liaw, Associate professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03805126
Other Study ID Numbers:
  • HSC-MS-18-1037
First Posted:
Jan 15, 2019
Last Update Posted:
Nov 6, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 6, 2020