Major DepressionReTIDESNCT00119028
Expanding and Testing VA Collaborative Care Models for Depression
A study testing Depression Care Quality Improvement Implementation in people with Major Depression and Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 6 sites in United States.
Trial summary
Based on the published evidence, collaborative care for depression is both necessary and sufficient for improving care and outcomes for depressed patients in primary care settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depression, Post-Traumatic Stress Disorder
- What is being tested?
- Depression Care Quality Improvement Implementation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2005to Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care providers at each participating site.
Who cannot join
- All providers not located at participating sites.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
VA Medical Center, Cincinnati
Cincinnati, Ohio, 45220
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Long Beach
Long Beach, California, 90822
VA Medical Center
Minneapolis, Minnesota, 55417
St. Cloud VA Medical Center
Saint Cloud, Minnesota, 56303
VA Medical Center
Shreveport, Louisiana, 71101
About this study
Based on the published evidence, collaborative care for depression is both necessary and sufficient for improving care and outcomes for depressed patients in primary care settings. The Translating Initiatives in Depression into Effective Solutions (TIDES) project, upon which ReTIDES is based, developed a VA-adapted version of collaborative care through input from veterans, clinicians, and managers. The initial TIDES project resulted in a clinically stable and effective model as tested in seven primary care practices in three VISNs. This positive result provided the basis for spreading and sustaining the TIDES model and initiating the study of national implementation strategies and issues.
Read the detailed description
Background:
Based on the published evidence, collaborative care for depression is both necessary and sufficient for improving care and outcomes for depressed patients in primary care settings. The Translating Initiatives in Depression into Effective Solutions (TIDES) project, upon which ReTIDES is based, developed a VA-adapted version of collaborative care through input from veterans, clinicians, and managers. The initial TIDES project resulted in a clinically stable and effective model as tested in seven primary care practices in three VISNs. This positive result provided the basis for spreading and sustaining the TIDES model and initiating the study of national implementation strategies and issues.
Objectives:
The objective of this grant was to carry out preparatory steps toward national implementation, including developing and investigating TIDES sustainability and partnering and marketing strategies. The project supported VISNs as learning organizations in the area of depression care improvement, and ultimately aimed to support as many as 8% to 10% of veterans nationally in improving their health and quality of life. Preparatory steps included 1) development of easily disseminated tools, including CPRS decision support, panel monitoring, and care manager and team training materials, 2) national and local dissemination to support TIDES model sustainability and spread and 3) evaluation using tools that would assess not only the success of this project, but could be used for quality monitoring during roll-out.
Methods:
Tools: We used the Chronic Illness Care model and Evidence Based Quality Improvement methods to develop tools for disseminating TIDES to additional medical centers and practices in 3 TIDES VISNs and two medical centers (with 10 practices) in one additional VISN. These tools were then used for national implementation. Dissemination: We served as technical expert consultants by 1) carrying out national and regional training; 2) linking to national patient care services, employee education, and information technology methods and priorities; and 3) supporting evidence-based quality improvement in new sites.We organized these efforts through a national dissemination plan.
Evaluation: We developed and applied 1) formative evaluation tools; 2) fine-tuned performance measure tools based on electronic data, and applied in a non-randomized quasi-experimental design (untreated control group with pretest and posttest); 3) a web-based survey for primary care clinicians and 4) an innovative implementation cost assessment approach. We also used 5) qualitative information on the process of dissemination , including links to national resources and 6) a randomized design to evaluate long term (18-month) cost effectiveness of TIDES.
Status:
Completed.
- Conditions
- Major Depression, Post-Traumatic Stress Disorder
- Being tested
- Depression Care Quality Improvement Implementation
- Keywords
- Quality Improvement, Cluster Randomized Trial, Care Model
- 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.
Depression Care Quality Improvement ImplementationProcedure or surgery
We will used a randomized design to evaluate long term (18-month) cost effectiveness of TIDES collaborative care in six intervention clinics with fully-implemented collaborative care compared to three matched and randomly-assigned usual care clinics. We used a non-randomized quasiexperimental design (untreated control group with pretest and posttest) to measure impacts on clinician performance, knowledge, and attitudes in 6 newly-implemented collaborative care intervention clinics compared to 6 matched usual care clinics
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Non-experimental QI intervention - No comparator Receives: Procedure: Depression Care Quality Improvement Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the intervention on depression performance measure, and provider attitudes. Quality of life-patient satisfaction.
Measured: 9/30/08
Secondary outcomes (1)
Cost-effectiveness, system costs, tool kit development
Measured: 9/30/08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionOct 2009
Why it stopped: This study was withdrawn prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa V. Rubenstein, MD MSPH, Principal investigator, VA Greater Los Angeles Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119028
- Sponsor's protocol ID
- MNT 03-215
- Other IDs
- Project #0024, PCC # 2004-121657
- Acronym
- ReTIDES
- Status last verified
- Apr 2012
- First submitted
- 1 Jul 2005
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rubenstein LV, Meredith LS, Parker LE, Gordon NP, Hickey SC, Oken C, Lee ML. Impacts of evidence-based quality improvement on depression in primary care: a randomized experiment. J Gen Intern Med. 2006 Oct;21(10):1027-35. doi: 10.1111/j.1525-1497.2006.00549.x. Epub 2006 Jul 7.
PubMed 16836631Sherman SE, Fotiades J, Rubenstein LV, Gilman SC, Vivell S, Chaney E, Yano EM, Felker B. Teaching systems-based practice to primary care physicians to foster routine implementation of evidence-based depression care. Acad Med. 2007 Feb;82(2):168-75. doi: 10.1097/ACM.0b013e31802d9165.
PubMed 17264696Fickel JJ, Parker LE, Yano EM, Kirchner JE. Primary care - mental health collaboration: an example of assessing usual practice and potential barriers. J Interprof Care. 2007 Mar;21(2):207-16. doi: 10.1080/13561820601132827.
PubMed 17365393Campbell 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 17503104Chaney 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 18279507Liu CF, Rubenstein LV, Kirchner JE, Fortney JC, Perkins MW, Ober SK, Pyne JM, Chaney EF. Organizational cost of quality improvement for depression care. Health Serv Res. 2009 Feb;44(1):225-44. doi: 10.1111/j.1475-6773.2008.00911.x.
PubMed 19146566Liu 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 19101777Smith JL, Williams JW Jr, Owen RR, Rubenstein LV, Chaney E. Developing a national dissemination plan for collaborative care for depression: QUERI Series. Implement Sci. 2008 Dec 31;3:59. doi: 10.1186/1748-5908-3-59.
PubMed 19117524Fickel JJ, Yano EM, Parker LE, Rubenstein LV. Clinic-level process of care for depression in primary care settings. Adm Policy Ment Health. 2009 Mar;36(2):144-58. doi: 10.1007/s10488-009-0207-1. Epub 2009 Feb 5.
PubMed 19194795Luck J, Hagigi F, Parker LE, Yano EM, Rubenstein LV, Kirchner JE. A social marketing approach to implementing evidence-based practice in VHA QUERI: the TIDES depression collaborative care model. Implement Sci. 2009 Sep 28;4:64. doi: 10.1186/1748-5908-4-64.
PubMed 19785754Foy R, Hempel S, Rubenstein L, Suttorp M, Seelig M, Shanman R, Shekelle PG. Meta-analysis: effect of interactive communication between collaborating primary care physicians and specialists. Ann Intern Med. 2010 Feb 16;152(4):247-58. doi: 10.7326/0003-4819-152-4-201002160-00010.
PubMed 20157139Parker LE, Ritchie MJ, Kirchner JE, Owen RR. Balancing health care evidence and art to meet clinical needs: policymakers' perspectives. J Eval Clin Pract. 2009 Dec;15(6):970-5. doi: 10.1111/j.1365-2753.2009.01209.x.
PubMed 20367694Rubenstein LV, Chaney EF, Ober S, Felker B, Sherman SE, Lanto A, Vivell S. Using evidence-based quality improvement methods for translating depression collaborative care research into practice. Fam Syst Health. 2010 Jun;28(2):91-113. doi: 10.1037/a0020302.
PubMed 20695669
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding and Testing VA Collaborative Care Models for Depression
- ClinicalTrials.gov ID
- NCT00119028
- Acronym / sponsor ID
- ReTIDES / MNT 03-215
- Conditions
- Major Depression, Post-Traumatic Stress Disorder
- Keywords
- Quality Improvement, Cluster Randomized Trial, Care Model
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Jul 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.
Based on the published evidence, collaborative care for depression is both necessary and sufficient for improving care and outcomes for depressed patients in primary care settings. The Translating Initiatives in Depression into Effective Solutions (TIDES) project, upon which ReTIDES is based, developed a VA-adapted version of collaborative care through input from veterans, clinicians, and managers. The initial TIDES project resulted in a clinically stable and effective model as tested in seven primary care practices in three VISNs. This positive result provided the basis for spreading and sustaining the TIDES model and initiating the study of national implementation strategies and issues.
Detailed description
Background:
Based on the published evidence, collaborative care for depression is both necessary and sufficient for improving care and outcomes for depressed patients in primary care settings. The Translating Initiatives in Depression into Effective Solutions (TIDES) project, upon which ReTIDES is based, developed a VA-adapted version of collaborative care through input from veterans, clinicians, and managers. The initial TIDES project resulted in a clinically stable and effective model as tested in seven primary care practices in three VISNs. This positive result provided the basis for spreading and sustaining the TIDES model and initiating the study of national implementation strategies and issues.
Objectives:
The objective of this grant was to carry out preparatory steps toward national implementation, including developing and investigating TIDES sustainability and partnering and marketing strategies. The project supported VISNs as learning organizations in the area of depression care improvement, and ultimately aimed to support as many as 8% to 10% of veterans nationally in improving their health and quality of life. Preparatory steps included 1) development of easily disseminated tools, including CPRS decision support, panel monitoring, and care manager and team training materials, 2) national and local dissemination to support TIDES model sustainability and spread and 3) evaluation using tools that would assess not only the success of this project, but could be used for quality monitoring during roll-out.
Methods:
Tools: We used the Chronic Illness Care model and Evidence Based Quality Improvement methods to develop tools for disseminating TIDES to additional medical centers and practices in 3 TIDES VISNs and two medical centers (with 10 practices) in one additional VISN. These tools were then used for national implementation. Dissemination: We served as technical expert consultants by 1) carrying out national and regional training; 2) linking to national patient care services, employee education, and information technology methods and priorities; and 3) supporting evidence-based quality improvement in new sites.We organized these efforts through a national dissemination plan.
Evaluation: We developed and applied 1) formative evaluation tools; 2) fine-tuned performance measure tools based on electronic data, and applied in a non-randomized quasi-experimental design (untreated control group with pretest and posttest); 3) a web-based survey for primary care clinicians and 4) an innovative implementation cost assessment approach. We also used 5) qualitative information on the process of dissemination , including links to national resources and 6) a randomized design to evaluate long term (18-month) cost effectiveness of TIDES.
Status:
Completed.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Depression Care Quality Improvement ImplementationNon-experimental QI intervention - No comparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care providers at each participating site.
Key exclusion criteria (1 listed)
- All providers not located at participating sites.
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 |
|---|---|---|
| Depression Care Quality Improvement ImplementationWe will used a randomized design to evaluate long term (18-month) cost effectiveness of TIDES collaborative care in six intervention clinics with fully-implemented collaborative care compared to three matched and randomly-assigned usual care clinics. We used a non-randomized quasiexperimental design (untreated control group with pretest and posttest) to measure impacts on clinician performance, knowledge, and attitudes in 6 newly-implemented collaborative care intervention clinics compared to 6 matched usual care clinics | Procedure or surgery | Arm 1 |
Primary outcome
Impact of the intervention on depression performance measure, and provider attitudes. Quality of life-patient satisfaction.
Time frame: 9/30/08
1 secondary outcome
Cost-effectiveness, system costs, tool kit development
Time frame: 9/30/08
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- Results publication: PubMed 16836631Rubenstein LV, Meredith LS, Parker LE, Gordon NP, Hickey SC, Oken C, Lee ML. Impacts of evidence-based quality improvement on depression in primary care: a randomized experiment. J Gen Intern Med. 2006 Oct;21(10):1027-35. doi: 10.1111/j.1525-1497.2006.00549.x. Epub 2006 Jul 7.
- Results publication: PubMed 17264696Sherman SE, Fotiades J, Rubenstein LV, Gilman SC, Vivell S, Chaney E, Yano EM, Felker B. Teaching systems-based practice to primary care physicians to foster routine implementation of evidence-based depression care. Acad Med. 2007 Feb;82(2):168-75. doi: 10.1097/ACM.0b013e31802d9165.
- Results publication: PubMed 17365393Fickel JJ, Parker LE, Yano EM, Kirchner JE. Primary care - mental health collaboration: an example of assessing usual practice and potential barriers. J Interprof Care. 2007 Mar;21(2):207-16. doi: 10.1080/13561820601132827.
- 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 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 19146566Liu CF, Rubenstein LV, Kirchner JE, Fortney JC, Perkins MW, Ober SK, Pyne JM, Chaney EF. Organizational cost of quality improvement for depression care. Health Serv Res. 2009 Feb;44(1):225-44. doi: 10.1111/j.1475-6773.2008.00911.x.
- 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 19117524Smith JL, Williams JW Jr, Owen RR, Rubenstein LV, Chaney E. Developing a national dissemination plan for collaborative care for depression: QUERI Series. Implement Sci. 2008 Dec 31;3:59. doi: 10.1186/1748-5908-3-59.
- Results publication: PubMed 19194795Fickel JJ, Yano EM, Parker LE, Rubenstein LV. Clinic-level process of care for depression in primary care settings. Adm Policy Ment Health. 2009 Mar;36(2):144-58. doi: 10.1007/s10488-009-0207-1. Epub 2009 Feb 5.
- Results publication: PubMed 19785754Luck J, Hagigi F, Parker LE, Yano EM, Rubenstein LV, Kirchner JE. A social marketing approach to implementing evidence-based practice in VHA QUERI: the TIDES depression collaborative care model. Implement Sci. 2009 Sep 28;4:64. doi: 10.1186/1748-5908-4-64.
- Results publication: PubMed 20157139Foy R, Hempel S, Rubenstein L, Suttorp M, Seelig M, Shanman R, Shekelle PG. Meta-analysis: effect of interactive communication between collaborating primary care physicians and specialists. Ann Intern Med. 2010 Feb 16;152(4):247-58. doi: 10.7326/0003-4819-152-4-201002160-00010.
- Results publication: PubMed 20367694Parker LE, Ritchie MJ, Kirchner JE, Owen RR. Balancing health care evidence and art to meet clinical needs: policymakers' perspectives. J Eval Clin Pract. 2009 Dec;15(6):970-5. doi: 10.1111/j.1365-2753.2009.01209.x.
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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.
Lisa V. Rubenstein, MD MSPH principal investigator
VA Greater Los Angeles Health Care System
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depression Care Quality Improvement Implementation in people with Major Depression and Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 6 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was withdrawn before enrolling participants, so there are no results.
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?
Impact of the intervention on depression performance measure, and provider attitudes. Quality of life-patient satisfaction. (time frame: 9/30/08). 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 NCT00119028, which also lists 13 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 24 Apr 2012.