Implementing Telemedicine-Based Collaborative Care for MDD in Contract CBOCs

This study has been withdrawn prior to enrollment.
(This study was withdrawn prior to enrollment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00317018
First received: April 19, 2006
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

Small contract VA Community Based Outpatient Clinics present unique challenges to implementation of collaborative care because of their distinct organizational characteristics and lack of on-site psychiatrists. A recent effectiveness study, successfully used telemedicine technologies to adapt the collaborative care model for small rural VA Community Based Outpatient Clinics. The purpose of the proposed study is to implement this telemedicine-based collaborative care model in small Contract VA Community Based Outpatient Clinics and determine its sustainability and cost-effectiveness.


Condition Intervention
Depression
Behavioral: Evidence-Based Quality Improvement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implementing Telemedicine-Based Collaborative Care for MDD in Contract CBOCs

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Reach, Effectiveness, Adoption, Implementation, and Maintenance, percent screening positive for depression, specialty mental health visits, antidepressant medication possession ratio, VA depression performance measure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Implementation Group
Behavioral: Evidence-Based Quality Improvement
The implementation intervention is known as Evidence-Based Quality Improvement (EBQI). EBQI is an adaptation of the Plan-Do-Study-Act cycles of Continuous Quality Improvement that emphasizes empirical evidence and the involvement of clinical and implementation experts (i.e., researchers). In the EBQI implementation intervention, both researchers (clinical and implementation experts) and local staff participate fully in the quality improvement process, with the researchers facilitating rather than dictating implementation efforts. Using EBQI methods, researchers and local staff adapt evidence-based practices for local resources, needs and preferences while maintaining fidelity to the evidence-base. PDSA cycles are used to continuously revise the adapted evidence-based practice based on feedback during pilot tests.
No Intervention: Arm 2
Control Group

  Hide Detailed Description

Detailed Description:

Rationale and Objectives: Implementation of collaborative care for depression is the highest priority for Mental Health QUERI, and preparing for national rollout of collaborative care is a key component of the VHA's Mental Health Strategic Plan. In addition, both the Mental Health Task Force Report and the CARES Commission Report have prioritized the provision of mental health services in all CBOCs. Secretary Principi has repeatedly emphasized the importance of this recommendation. However, small Contract CBOCs present unique challenges to implementation of collaborative care because of their distinct organizational characteristics, long distances to parent VAMCs, and lack of onsite psychiatrists. The Telemedicine Enhanced Antidepressant Management (TEAM) study, successfully used telemedicine technologies to adapt the collaborative care model for small CBOCs lacking onsite psychiatrists. The purpose of the proposed RIPPLE study is to implement and evaluate this telemedicine-based collaborative care model in small Contract CBOCs. The goals and aims of the RIPPLE study are:

Goal 1 To adapt and apply implementation strategies developed for TIDES/RETIDES in order to deliver telemedicine-based collaborative care services in small contract CBOCs.

Goal 2: To evaluate the implementation of this evidence-based best-practice with respect to its clinical impact on the population of patients with MDD and the system of care. The corresponding specific aims are:

Specific Aim 1: Document and evaluate the process of implementing, refining, and sustaining telemedicine-based collaborative care at contract CBOCs.

Specific Aim 2: Estimate the clinical impact of telemedicine-based collaborative care at implementation sites relative to usual care at control sites.

Specific Aim 3: Estimate the system-level cost-effectiveness of telemedicine-based collaborative care at contract CBOCs.

Research Design and Study Setting: The study will be conducted in 26 contract CBOCs in VISN 16 and VISN 22. The analyses will be based on a pre-post quasi-experimental study design with a non-equivalent control group. The telemedicine-based collaborative care program will be implemented at 11 contract CBOCs without onsite psychiatrists and cost/outcomes will be compared to those at 15 similar control sites.

Data Collection and Analysis: Data will be collected from survey, key informant interviews, VISTA, and the Austin Automation Center. Descriptive statistics will be used to describe the degree of adoption (i.e., reach, effectiveness, adoption, implementation, and maintenance). The clinical impact on the patient population will be estimated using random effects models with individual patients as the unit of analysis. The impact on the system will be estimated using a Systems Cost Effectiveness Analysis.

Significance: Evaluating strategies for implementing telemedicine-based collaborative care in contract CBOCs should be a high priority for VA for several reasons. First, VA's Mental Health Strategic Plan includes plans for the rollout of collaborative care throughout the entire VA health care system. Second, the importance of providing mental health services in all CBOCs is highlighted by the recent introduction of a performance measure targeting mental health in CBOCs. Third, there are 183 contract CBOCs in the VA health care system, most of which have no on-site psychiatrists and are located in rural areas far from parent VAMCs. Fourth, the TEAM collaborative care model has been demonstrated to significantly and substantially improve depression outcomes in these small rural CBOCs. While the implementation of collaborative care in large VA-staffed clinics is an immensely challenging task, implementing collaborative care in small contract clinics is even more challenging. To prepare for national rollout, it is imperative that implementation strategies be developed and evaluated for these difficult settings in order to avoid the creation of a two-tiered system of care. National rollout strategies must target contract CBOCs to ensure access to collaborative care for all veterans and to prevent future health disparities. In addition, the results of the RIPPLE study will provide a template for the development of best-practice implementation strategies targeting other high priority QUERI disorders in contract CBOCs.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • veteran
  • depression
  • patient at Little Rock VAMC, Loma Linda VAMC, or Greater Los Angeles VAMC

Exclusion Criteria:

  • veteran
  • depression
  • patient at Little Rock VAMC, Loma Linda VAMC, or Greater Los Angeles VAMC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317018

Locations
United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: John C. Fortney, PhD Central Arkansas Veterans Healthcare System (North Little Rock)
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00317018     History of Changes
Other Study ID Numbers: IMV 04-360
Study First Received: April 19, 2006
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
depression
quality improvement
implementation
translation
evidence-based practice
collaborative care
adoption
sustainability
cost-effectiveness
rural

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014