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Evaluation Study of TIDES Depression Care Quality Improvement Intervention

6. april 2015 opdateret af: US Department of Veterans Affairs

Well-being Among Veterans Enhancement Study (WAVES)

In spite of the impact on veteran�s health status and treatment cost, depression is under-diagnosed and under-treated. The goal of this study is to learn how to implement a previously tested, effective collaborative care model for improving the quality of depression care across multiple Veterans Integrated Service Networks (VISNs). To achieve this goal, we are conducting a randomized controlled trial of evidence-based quality improvement (EBQI), a dissemination method that relies on expert design and local implementation of evidence-based practice interventions. We hypothesize that EBQI will result in increased rates of assessment and appropriate management of depression. Results will be useful in designing realistic chronic care programs and performance measures for continuing care improvement.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Objectives: Our primary objective is to evaluate whether collaborative care EBQI results in increased rates of assessment and appropriate management of depression and decreased depressive symptomatology for veterans. Our secondary objective is to evaluate the effect of EBQI on organizational outcomes.

Methods: Three VISNs, 10, 16 and 23, are participating. Three primary care clinics within each VISN are randomized, two to the intervention and one to usual care, for a total of nine study sites. In the intervention clinics, VA leadership, assisted by study staff, tailor and implement a depression care program for patient assessment, patient self-management support, provider education, primary and mental health collaboration, and care management. The usual care clinics participate only in the evaluation. Patient recruitment is through a telephone interview. Patients who are at risk for major depression are recruited, 67 from each site. Patient outcomes including depression symptom severity on the PHQ-9 and the VA SF-12 are being assessed by telephone at six months post enrollment. Other outcome variables are adequacy of antidepressant trials, psychotherapy and specialty care visits, and treatment adherence. A utilization and cost analysis will be conducted. VISN and VAMC leadership are surveyed to assess organizational outcomes. Data is being collected through VA administrative databases, patient and staff interviews, and study records. Power calculations and data analysis planning reflect the clustered sample design.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

750

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Sepulveda, California, Forenede Stater, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Louis Stokes VA Medical Center, Cleveland, OH
    • Washington
      • Seattle, Washington, Forenede Stater, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Enrolled as a pt in the VA Healthcare System
  • screens positive for major depression
  • has a scheduled visit at a primary care site taking part in the study

Exclusion Criteria:

  • severe alcohol abuse
  • psychosis
  • dementia
  • acutely suicidal (at screening)
  • lack of access to or ability to use a phone

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Arm 1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs

Sekundære resultatmål

Resultatmål
Adherence to appropriate treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Edmund F. Chaney, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Ledende efterforsker: Lisa V. Rubenstein, MD MSPH, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2003

Studieafslutning (Faktiske)

1. marts 2006

Datoer for studieregistrering

Først indsendt

16. marts 2005

Først indsendt, der opfyldte QC-kriterier

16. marts 2005

Først opslået (Skøn)

17. marts 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2015

Sidst verificeret

1. februar 2007

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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