Social Determinants of HealthNCT03364543
The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs
An observational study of Social Determinants of Health, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health
- What is being tested?
- Access to the Medical-Legal Partnership Group and Access to social worker and a community worker
- How many people
- 911 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2018to 1 Feb 2019
- Phase
- Observational
- 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
Study population: These are adults patients accessing primary care clinics.
Who may be able to join
- English- or Spanish- speaking
- screen positive for health-harming legal needs (HHLNs)
Who cannot join
- Those unable or unwilling to consent to legal services
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
UTHealth Comprehensive Sickle Cell Center
Houston, Texas, 77030
About this study
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care.
- Conditions
- Social Determinants of Health
- Being tested
- Access to the Medical-Legal Partnership Group, Access to social worker and a community worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to the Medical-Legal Partnership GroupOther
The Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs.
Access to social worker and a community workerOther
Access to social worker and a community worker, but no systematic process for addressing health-harming legal needs.
| Study group | Role | What they receive |
|---|---|---|
| Medical-Legal Partnership Group | The Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs. This group will also have access to access to a social worker and a community worker. Receives: Other: Access to the Medical-Legal Partnership Group; Other: Access to social worker and a community worker | |
| Usual Care | Access to a social worker and a community worker, but no systematic process for addressing health-harming legal needs. Receives: Other: Access to social worker and a community worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who had an emergency department visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start16 Apr 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winston Liaw, The University of Texas Health Science Center, Houston
- Investigators
- Winston Liaw, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364543
- Sponsor's protocol ID
- 2017-048
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2017
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs
- ClinicalTrials.gov ID
- NCT03364543
- Acronym / sponsor ID
- 2017-048
- Conditions
- Social Determinants of Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 6 Dec 2017 (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 purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical-Legal Partnership Group | – | Other: Access to the Medical-Legal Partnership Group, Other: Access to social worker and a community workerThe Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs. This group will also have access to access to a social worker and a community worker. |
| Usual Care | – | Other: Access to social worker and a community workerAccess to a social worker and a community worker, but no systematic process for addressing health-harming legal needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- These are adults patients accessing primary care clinics.
Key inclusion criteria (2 listed)
- English- or Spanish- speaking
- screen positive for health-harming legal needs (HHLNs)
Key exclusion criteria (1 listed)
- Those unable or unwilling to consent to legal services
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 |
|---|---|---|
| Access to the Medical-Legal Partnership GroupThe Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs. | Other | Medical-Legal Partnership Group |
| Access to social worker and a community workerAccess to social worker and a community worker, but no systematic process for addressing health-harming legal needs. | Other | Medical-Legal Partnership Group, Usual Care |
Primary outcome
Number of participants who had an emergency department visit
Time frame: 6 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.
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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 principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Determinants of Health, run by The University of Texas Health Science Center, Houston at 2 sites 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 2 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 2 sites 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?
Number of participants who had an emergency department visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.