- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119028
Expanding and Testing VA Collaborative Care Models for Depression (ReTIDES)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Long Beach, California, United States, 90822
- Long Beach
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71101
- VA Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- VA Medical Center
-
St Cloud, Minnesota, United States, 56303
- St. Cloud VA Medical Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- VA Medical Center, Cincinnati
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E DeBakey VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary care providers at each participating site.
Exclusion Criteria:
- All providers not located at participating sites.
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
Non-experimental QI intervention - No comparator
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Impact of the intervention on depression performance measure, and provider attitudes. Quality of life-patient satisfaction.
Time Frame: 9/30/08
|
9/30/08
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cost-effectiveness, system costs, tool kit development
Time Frame: 9/30/08
|
9/30/08
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa V. Rubenstein, MD MSPH, VA Greater Los Angeles Health Care System
Publications and helpful links
General Publications
- 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.
- 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.
- Sherman 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.
- Fickel 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.
- Liu 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.
- Smith 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.
- Fickel 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.
- Luck 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.
- Foy 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.
- Parker 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.
- Rubenstein 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNT 03-215
- Project #0024
- PCC # 2004-121657
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depression
-
Stanford UniversityTerminatedMajor Depressive Disorder | Major Depressive Episode | Major Depressive Disorder, Recurrent | Major Depression Mild | Major Depression Moderate | Major Depression SevereUnited States
-
Centre Hospitalier Universitaire de BesanconH. Lundbeck A/SCompletedResistant Major DepressionFrance
-
Hawler Medical UniversityCompleted
-
First Affiliated Hospital of Zhejiang UniversityRecruiting
-
University of PittsburghCompletedPostpartum Major DepressionUnited States
-
Si TianmeiUnknownMajor Depression DisorderChina
-
The Hong Kong Polytechnic UniversityNot yet recruitingHealthy | Major Depression in Remission
-
AstraZenecaCompletedNon-psychotic Unipolar Major DepressionArgentina
-
Ruijin HospitalTerminatedTreatment Resistant Major Depression DisorderChina
-
Zentrum für Integrative PsychiatrieGerman Research FoundationCompletedCognitive Performance in Major DepressionGermany
Clinical Trials on Depression Care Quality Improvement Implementation
-
US Department of Veterans AffairsCompletedPTSD | Major DepressionUnited States
-
Agency for Healthcare Research and Quality (AHRQ)University of Pittsburgh; Kaiser Permanente; RAND; Venice Family ClinicCompleted
-
Centre for the AIDS Programme of Research in South...Institute for Healthcare Improvement; BroadReach Health CareCompleted
-
Institut für Pharmakologie und Präventive MedizinEdwards LifesciencesActive, not recruitingTranscatheter Aortic Valve Implantation (TAVI)Spain, Italy, France, Germany, Austria, Czechia, Romania
-
City University of New York, School of Public HealthHanoi University of Public HealthRecruiting
-
Dr. Derek ExnerUnknownMyocardial Infarction | Heart Failure | DeathCanada
-
Hospital Israelita Albert EinsteinNovartis; epHealth primary care solutionsRecruitingCardiovascular Diseases | Atherosclerosis | DyslipidemiasBrazil
-
University of California, San FranciscoPopulation Services InternationalCompleted
-
University of California, Los AngelesUniversity of Washington; Kaiser Foundation Research InstituteCompletedSuicidal Ideation | Suicide | Suicidal Behavior | Self-Harm, DeliberateUnited States
-
Institute for Clinical Effectiveness and Health...Inter-American Development BankUnknownColorectal NeoplasmsArgentina