Implementing Telemedicine-Based Collaborative Care for MDD in Contract CBOCs

April 25, 2014 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92357
        • VA Medical Center, Loma Linda
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cost-effectiveness
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: John C. Fortney, PhD, Central Arkansas Veterans Healthcare System (North Little Rock)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 19, 2006

First Submitted That Met QC Criteria

April 19, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMV 04-360

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.

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