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OpenTrials
Completed

NCT Number: NCT03805126

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.

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Key information

Conditions

Health-harming Legal Needs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jensen Clinic

Houston, Texas, 77093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medical Legal Partnership

Behavioral

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.

Usual Care

Behavioral

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

Primary outcomes

  1. Stress as assessed by the Perceived Stress Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: baseline

  14. Number of Urgent Care Visits

    Time frame: 3 months

  15. Number of Urgent Care Visits

    Time frame: 6 months

  16. Number of Urgent Care Visits

    Time frame: 12 months

  17. Number of Emergency Department Visits

    Time frame: baseline

  18. Number of Emergency Department Visits

    Time frame: 3 months

  19. Number of Emergency Department Visits

    Time frame: 6 months

  20. Number of Emergency Department Visits

    Time frame: 12 months

  21. Number of Hospital Visits

    Time frame: baseline

  22. Number of Hospital Visits

    Time frame: 3 months

  23. Number of Hospital Visits

    Time frame: 6 months

  24. Number of Hospital Visits

    Time frame: 12 months

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

    Time frame: baseline

  26. Percentage of baseline health-harming legal needs that were resolved

    Time frame: 3 months

  27. Percentage of baseline health-harming legal needs that were resolved

    Time frame: 6 months

  28. Percentage of baseline health-harming legal needs that were resolved

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Texas Medical Center Foundation
  • University of Houston
  • William Marsh Rice University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2019
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.