Evaluation Study of TIDES Depression Care Quality Improvement Intervention

PTSD Clinical Trial

Official title:

Well-being Among Veterans Enhancement Study (WAVES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105820
• Other study ID #: MHI 99-375
• Status: Completed
• Phase: N/A
• First received: March 16, 2005
• Last updated: April 6, 2015
• Start date: June 2003
• Est. completion date: March 2006

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depression
• PTSD

Intervention

Procedure:
• System level depression care quality improvement

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (14)

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.2 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Adherence to appropriate treatment			No