Health-harming Legal NeedsNCT03805126
Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals
A study testing Medical Legal Partnership in people with Health-harming Legal Needs, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health-harming Legal Needs
- What is being tested?
- Medical Legal Partnership
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level)
- individuals with HHLNs
- English or Spanish speaking
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health-harming Legal Needs
- Being tested
- Medical Legal Partnership, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Legal PartnershipBehavioural
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 CareBehavioural
Usual care includes consultation with a social worker and a community health worker.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Medical Legal Partnership; Behavioral: Usual Care |
| Usual Care | Active comparator | Usual care includes consultation with a social worker and a community health worker. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Number of Urgent Care Visits
Measured: baseline
Number of Urgent Care Visits
Measured: 3 months
Number of Urgent Care Visits
Measured: 6 months
Number of Urgent Care Visits
Measured: 12 months
Number of Emergency Department Visits
Measured: baseline
Number of Emergency Department Visits
Measured: 3 months
Number of Emergency Department Visits
Measured: 6 months
Number of Emergency Department Visits
Measured: 12 months
Number of Hospital Visits
Measured: baseline
Number of Hospital Visits
Measured: 3 months
Number of Hospital Visits
Measured: 6 months
Number of Hospital Visits
Measured: 12 months
Percentage of baseline health-harming legal needs that were resolved
Measured: baseline
Percentage of baseline health-harming legal needs that were resolved
Measured: 3 months
Percentage of baseline health-harming legal needs that were resolved
Measured: 6 months
Percentage of baseline health-harming legal needs that were resolved
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start14 Feb 2019
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health-harming Legal NeedsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Medical Center Foundation, University of Houston, William Marsh Rice University
- Responsible party
- Principal investigator, Winston Liaw, The University of Texas Health Science Center, Houston
- Investigators
- Winston Liaw, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805126
- Sponsor's protocol ID
- HSC-MS-18-1037
- Status last verified
- Nov 2020
- First submitted
- 11 Jan 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37028914
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals
- ClinicalTrials.gov ID
- NCT03805126
- Acronym / sponsor ID
- HSC-MS-18-1037
- Conditions
- Health-harming Legal Needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Texas Medical Center Foundation, University of Houston, William Marsh Rice University
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Legal Partnership | Experimental | Behavioral: Medical Legal Partnership, Behavioral: Usual CareWith 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 | Active comparator | Behavioral: Usual CareUsual care includes consultation with a social worker and a community health worker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level)
- individuals with HHLNs
- English or Spanish speaking
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Legal PartnershipWith 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. | Behavioural | Medical Legal Partnership |
| Usual CareUsual care includes consultation with a social worker and a community health worker. | Behavioural | Medical Legal Partnership, Usual Care |
Primary outcome
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.
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.
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.
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.
28 secondary outcomes
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Time frame: baseline
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Time frame: 3 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Time frame: 6 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Time frame: 12 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Time frame: baseline
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Time frame: 3 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Time frame: 6 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Time frame: 12 months
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: baseline
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 3 months
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6 months
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 12 months
Number of Urgent Care Visits
Time frame: baseline
Number of Urgent Care Visits
Time frame: 3 months
Number of Urgent Care Visits
Time frame: 6 months
Number of Urgent Care Visits
Time frame: 12 months
Number of Emergency Department Visits
Time frame: baseline
Number of Emergency Department Visits
Time frame: 3 months
Number of Emergency Department Visits
Time frame: 6 months
Number of Emergency Department Visits
Time frame: 12 months
Number of Hospital Visits
Time frame: baseline
Number of Hospital Visits
Time frame: 3 months
Number of Hospital Visits
Time frame: 6 months
Number of Hospital Visits
Time frame: 12 months
Percentage of baseline health-harming legal needs that were resolved
Time frame: baseline
Percentage of baseline health-harming legal needs that were resolved
Time frame: 3 months
Percentage of baseline health-harming legal needs that were resolved
Time frame: 6 months
Percentage of baseline health-harming legal needs that were resolved
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 37028914Liaw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winston Liaw, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Legal Partnership in people with Health-harming Legal Needs, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress as assessed by the Perceived Stress Scale (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.