Major DepressionNCT00105820
Evaluation Study of TIDES Depression Care Quality Improvement Intervention
A study testing System level depression care quality improvement in people with Major Depression and PTSD, run by US Department of Veterans Affairs at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression, PTSD
- What is being tested?
- System level depression care quality improvement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2003to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe alcohol abuse
- psychosis
- dementia
- acutely suicidal (at screening)
- lack of access to or ability to use a phone
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Official title: Well-being Among Veterans Enhancement Study (WAVES)
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.
Read the 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.
- Conditions
- Major Depression, PTSD
- Being tested
- System level depression care quality improvement
- Keywords
- Evaluation, Quality improvement, Cluster randomized trial, Care model, Collaborative care, Informatics
- Medical subject headings
- Depressive Disorder, Major, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System level depression care quality improvementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: System level depression care quality improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Adherence to appropriate treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startJun 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Edmund F. Chaney, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WALisa V. Rubenstein, MD MSPH, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105820
- Sponsor's protocol ID
- MHI 99-375
- Status last verified
- Feb 2007
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15067160Kanter 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.
PubMed 15213794Felker 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.
PubMed 16862248Fortney 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.
PubMed 16174141Chaney 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.
PubMed 18279507Campbell 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.
PubMed 17503104Liu 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.
PubMed 19101777Waltz 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.
PubMed 25090611Lombardero 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.
PubMed 24290879Bolkan 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.
PubMed 23370463Bonner 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.
PubMed 23297184Yano 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.
PubMed 21975821Zivin 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.
PubMed 22771108Chaney 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.
PubMed 22032247
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-being Among Veterans Enhancement Study (WAVES)
- ClinicalTrials.gov ID
- NCT00105820
- Acronym / sponsor ID
- MHI 99-375
- Conditions
- Major Depression, PTSD
- Keywords
- Evaluation, Quality improvement, Cluster randomized trial, Care model, Collaborative care, Informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 17 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: System level depression care quality improvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- severe alcohol abuse
- psychosis
- dementia
- acutely suicidal (at screening)
- lack of access to or ability to use a phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| System level depression care quality improvement | Procedure or surgery | Arm 1 |
Primary outcome
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
1 secondary outcome
Adherence to appropriate treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 15067160Felker 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.
- Results publication: PubMed 15213794Kanter 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.
- Results publication: PubMed 16862248Felker 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.
- Results publication: PubMed 16174141Fortney 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.
- Results publication: PubMed 18279507Chaney 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.
- Results publication: PubMed 17503104Campbell 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.
- Results publication: PubMed 19101777Liu 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.
- Results publication: PubMed 25090611Waltz 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.
- Results publication: PubMed 24290879Lombardero 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.
- Results publication: PubMed 23370463Bolkan 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.
- Results publication: PubMed 23297184Bonner 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.
- Results publication: PubMed 21975821Yano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund F. Chaney, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Lisa V. Rubenstein, MD MSPH principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing System level depression care quality improvement in people with Major Depression and PTSD, run by US Department of Veterans Affairs at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105820, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.