Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105820
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Brief Title:
Evaluation Study of TIDES Depression Care Quality Improvement Intervention
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Well-being Among Veterans Enhancement Study WAVES
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In spite of the impact on veterans 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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None