Evaluation Study of TIDES Depression Care Quality Improvement Intervention
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| First Received Date ICMJE | March 16, 2005 | ||||||||
| Last Updated Date | April 18, 2013 | ||||||||
| Start Date ICMJE | June 2003 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00105820 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Adherence to appropriate treatment [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation Study of TIDES Depression Care Quality Improvement Intervention | ||||||||
| Official Title ICMJE | Well-being Among Veterans Enhancement Study (WAVES) | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: System level depression care quality improvement | ||||||||
| Study Arm (s) | Arm 1
Intervention: Procedure: System level depression care quality improvement |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 750 | ||||||||
| Completion Date | March 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00105820 | ||||||||
| Other Study ID Numbers ICMJE | MHI 99-375 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | February 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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