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Evaluation Study of TIDES Depression Care Quality Improvement Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105820
First Posted: March 17, 2005
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Major Depression PTSD Procedure: System level depression care quality improvement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Well-being Among Veterans Enhancement Study (WAVES)

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Adherence to appropriate treatment

Estimated Enrollment: 750
Study Start Date: June 2003
Study Completion Date: March 2006
Arms Assigned Interventions
Arm 1 Procedure: System level depression care quality improvement

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105820


Locations
United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Edmund F. Chaney, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
Principal Investigator: Lisa V. Rubenstein, MD MSPH VA Greater Los Angeles Healthcare System, Sepulveda, CA
  More Information

Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105820     History of Changes
Other Study ID Numbers: MHI 99-375
First Submitted: March 16, 2005
First Posted: March 17, 2005
Last Update Posted: April 7, 2015
Last Verified: February 2007

Keywords provided by VA Office of Research and Development:
Evaluation
Quality improvement
Cluster randomized trial
Care model
Collaborative care
Informatics

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders