- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105820
Evaluation Study of TIDES Depression Care Quality Improvement Intervention
Well-being Among Veterans Enhancement Study (WAVES)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sepulveda, California, United States, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Louis Stokes VA Medical Center, Cleveland, OH
-
-
Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 |
---|
Adherence to appropriate treatment
|
Collaborators and Investigators
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
Publications and helpful links
General Publications
- Felker BL, Barnes RF, Greenberg DM, Chaney EF, Shores MM, Gillespie-Gateley L, Buike MK, Morton CE. Preliminary outcomes from an integrated mental health primary care team. Psychiatr Serv. 2004 Apr;55(4):442-4. doi: 10.1176/appi.ps.55.4.442.
- Kanter JW, Epler AJ, Chaney EF, Liu CF, Heagerty P, Lin P, Felker B, Hedrick SC. Comparison of 3 Depression Screening Methods and Provider Referral in a Veterans Affairs Primary Care Clinic. Prim Care Companion J Clin Psychiatry. 2003 Dec;5(6):245-250. doi: 10.4088/pcc.v05n0601.
- Felker BL, Chaney E, Rubenstein LV, Bonner LM, Yano EM, Parker LE, Worley LL, Sherman SE, Ober S. Developing effective collaboration between primary care and mental health providers. Prim Care Companion J Clin Psychiatry. 2006;8(1):12-6. doi: 10.4088/pcc.v08n0102.
- Fortney JC, Steffick DE, Burgess JF Jr, Maciejewski ML, Petersen LA. Are primary care services a substitute or complement for specialty and inpatient services? Health Serv Res. 2005 Oct;40(5 Pt 1):1422-42. doi: 10.1111/j.1475-6773.2005.00424.x.
- Chaney E, Rabuck LG, Uman J, Mittman DC, Simons C, Simon BF, Ritchie M, Cody M, Rubenstein LV. Human subjects protection issues in QUERI implementation research: QUERI Series. Implement Sci. 2008 Feb 15;3:10. doi: 10.1186/1748-5908-3-10.
- Campbell DG, Felker BL, Liu CF, Yano EM, Kirchner JE, Chan D, Rubenstein LV, Chaney EF. Prevalence of depression-PTSD comorbidity: implications for clinical practice guidelines and primary care-based interventions. J Gen Intern Med. 2007 Jun;22(6):711-8. doi: 10.1007/s11606-006-0101-4.
- Liu CF, Bolkan C, Chan D, Yano EM, Rubenstein LV, Chaney EF. Dual use of VA and non-VA services among primary care patients with depression. J Gen Intern Med. 2009 Mar;24(3):305-11. doi: 10.1007/s11606-008-0867-7. Epub 2008 Dec 20.
- Waltz TJ, Campbell DG, Kirchner JE, Lombardero A, Bolkan C, Zivin K, Lanto AB, Chaney EF, Rubenstein LV. Veterans with depression in primary care: provider preferences, matching, and care satisfaction. Fam Syst Health. 2014 Dec;32(4):367-77. doi: 10.1037/fsh0000071. Epub 2014 Aug 4.
- Lombardero A, Campbell DG, Harris KJ, Chaney EF, Lanto AB, Rubenstein LV. Prevalence and correlates of smoking status among veterans affairs primary care patients with probable major depressive disorder. Addict Behav. 2014 Mar;39(3):538-45. doi: 10.1016/j.addbeh.2013.10.030. Epub 2013 Nov 4.
- Bolkan CR, Bonner LM, Campbell DG, Lanto A, Zivin K, Chaney E, Rubenstein LV. Family involvement, medication adherence, and depression outcomes among patients in veterans affairs primary care. Psychiatr Serv. 2013 May 1;64(5):472-8. doi: 10.1176/appi.ps.201200160.
- Bonner LM, Lanto AB, Bolkan C, Watson GS, Campbell DG, Chaney EF, Zivin K, Rubenstein LV. Help-seeking from clergy and spiritual counselors among veterans with depression and PTSD in primary care. J Relig Health. 2013 Sep;52(3):707-18. doi: 10.1007/s10943-012-9671-0.
- Yano EM, Chaney EF, Campbell DG, Klap R, Simon BF, Bonner LM, Lanto AB, Rubenstein LV. Yield of practice-based depression screening in VA primary care settings. J Gen Intern Med. 2012 Mar;27(3):331-8. doi: 10.1007/s11606-011-1904-5.
- Zivin K, Campbell DG, Lanto AB, Chaney EF, Bolkan C, Bonner LM, Miller EM, Valenstein M, Waltz TJ, Rubenstein LV. Relationships between mood and employment over time among depressed VA primary care patients. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):468-77. doi: 10.1016/j.genhosppsych.2012.05.008. Epub 2012 Jul 6.
- Chaney EF, Rubenstein LV, Liu CF, Yano EM, Bolkan C, Lee M, Simon B, Lanto A, Felker B, Uman J. Implementing collaborative care for depression treatment in primary care: a cluster randomized evaluation of a quality improvement practice redesign. Implement Sci. 2011 Oct 27;6:121. doi: 10.1186/1748-5908-6-121.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHI 99-375
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