Expanding and Testing VA Collaborative Care Models for Depression

Post-Traumatic Stress Disorder Clinical Trial

— ReTIDES  

Official title:

Expanding and Testing VA Collaborative Care Models for Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00119028
• Other study ID #: MNT 03-215
• Secondary ID: Project #0024PCC
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2005
• Last updated: April 23, 2012
• Start date: April 2005
• Est. completion date: October 2009

Study information

• Verified date: April 2012
• 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

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary care providers at each participating site.

Exclusion Criteria:

• All providers not located at participating sites.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Depression Care Quality Improvement Implementation
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

Locations

Country	Name	City	State
United States	VA Medical Center, Cincinnati	Cincinnati	Ohio
United States	Michael E DeBakey VA Medical Center	Houston	Texas
United States	Long Beach	Long Beach	California
United States	VA Medical Center	Minneapolis	Minnesota
United States	VA Medical Center	Shreveport	Louisiana
United States	St. Cloud VA Medical Center	St Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (13)

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

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. — View Citation

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. — View Citation

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 — 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

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. Epub 2006 Jul 7. — View Citation

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. Review — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of the intervention on depression performance measure, and provider attitudes. Quality of life-patient satisfaction.		9/30/08	No
Secondary	Cost-effectiveness, system costs, tool kit development		9/30/08	No