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OpenTrials
Completed

NCT Number: NCT00105820

Evaluation Study of TIDES Depression Care Quality Improvement Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Healthcare System, Sepulveda, CA, Sepulveda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

System level depression care quality improvement

Procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. Adherence to appropriate treatment

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Well-being Among Veterans Enhancement Study (WAVES)

Important dates

Study start
2003
Study completion
2006
First posted
Mar 17, 2005
Registry last updated
Apr 7, 2015

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.

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