Evaluation Study of TIDES Depression Care Quality Improvement Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Well-being Among Veterans Enhancement Study (WAVES)

Conditions
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Major Depression, PTSD

Intervention / Treatment
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* Procedure: System level depression care quality improvement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Procedure: System level depression care quality improvement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to appropriate treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaluation, Quality improvement, Cluster randomized trial, Care model, Collaborative care, Informatics