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

4. november 2020 oppdatert av: Winston Liaw, The University of Texas Health Science Center, Houston
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

160

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77093
        • Jensen Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Atferdsmessig: Usual Care
Usual care includes consultation with a social worker and a community health worker.
Aktiv komparator: Usual Care
Usual care includes consultation with a social worker and a community health worker.
Atferdsmessig: Usual Care
Usual care includes consultation with a social worker and a community health worker.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Stress as assessed by the Perceived Stress Scale
Tidsramme: 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.
baseline
Stress as assessed by the Perceived Stress Scale
Tidsramme: 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 months
Stress as assessed by the Perceived Stress Scale
Tidsramme: 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.
6 months
Stress as assessed by the Perceived Stress Scale
Tidsramme: 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.
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Tidsramme: 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.
baseline
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Tidsramme: 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 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Tidsramme: 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.
6 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
Tidsramme: 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.
12 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Tidsramme: 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.
baseline
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Tidsramme: 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.
3 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Tidsramme: 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.
6 months
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
Tidsramme: 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.
12 months
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 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.
baseline
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 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.
3 months
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 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.
6 months
Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 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.
12 months
Number of Urgent Care Visits
Tidsramme: baseline
baseline
Number of Urgent Care Visits
Tidsramme: 3 months
3 months
Number of Urgent Care Visits
Tidsramme: 6 months
6 months
Number of Urgent Care Visits
Tidsramme: 12 months
12 months
Number of Emergency Department Visits
Tidsramme: baseline
baseline
Number of Emergency Department Visits
Tidsramme: 3 months
3 months
Number of Emergency Department Visits
Tidsramme: 6 months
6 months
Number of Emergency Department Visits
Tidsramme: 12 months
12 months
Number of Hospital Visits
Tidsramme: baseline
baseline
Number of Hospital Visits
Tidsramme: 3 months
3 months
Number of Hospital Visits
Tidsramme: 6 months
6 months
Number of Hospital Visits
Tidsramme: 12 months
12 months
Percentage of baseline health-harming legal needs that were resolved
Tidsramme: baseline
baseline
Percentage of baseline health-harming legal needs that were resolved
Tidsramme: 3 months
3 months
Percentage of baseline health-harming legal needs that were resolved
Tidsramme: 6 months
6 months
Percentage of baseline health-harming legal needs that were resolved
Tidsramme: 12 months
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Texas Health Science Center, Houston

Samarbeidspartnere

University of Houston
William Marsh Rice University
Texas Medical Center Foundation

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. februar 2019

Primær fullføring (Faktiske)

11. september 2020

Studiet fullført (Faktiske)

11. september 2020

Datoer for studieregistrering

Først innsendt

11. januar 2019

Først innsendt som oppfylte QC-kriteriene

11. januar 2019

Først lagt ut (Faktiske)

15. januar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HSC-MS-18-1037

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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