Evaluation Study of TIDES Depression Care Quality Improvement Intervention

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00105820

Collaborator

(none)

750

Enrollment

Locations

Arm

Duration (Months)

250

Patients Per Site

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Major Depression PTSD	Procedure: System level depression care quality improvement	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Well-being Among Veterans Enhancement Study (WAVES)

Study Start Date :

Jun 1, 2003

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1	Procedure: System level depression care quality improvement

Arm

Intervention/Treatment

Other: Arm 1

Procedure: System level depression care quality improvement

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California	United States	91343
2	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio	United States	44106
3	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington	United States	98108

Sponsors and Collaborators

US Department of Veterans Affairs

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