DepressionNCT00317018
Implementing Telemedicine-Based Collaborative Care for MDD in Contract CBOCs
A study testing Evidence-Based Quality Improvement in people with Depression, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression
- What is being tested?
- Evidence-Based Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Sep 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
- veteran
- depression
- patient at Little Rock VAMC, Loma Linda VAMC, or Greater Los Angeles VAMC
Who cannot join
- veteran
- depression
- patient at Little Rock VAMC, Loma Linda VAMC, or Greater Los Angeles VAMC
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Medical Center, Loma Linda
Loma Linda, California, 92357
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Evidence-Based Quality Improvement
- Keywords
- depression, quality improvement, implementation, translation, evidence-based practice, collaborative care, adoption, sustainability, cost-effectiveness, rural
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based Quality ImprovementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Implementation Group Receives: Behavioral: Evidence-Based Quality Improvement |
| Arm 2 | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach, Effectiveness, Adoption, Implementation, and Maintenance, percent screening positive for depression, specialty mental health visits, antidepressant medication possession ratio, VA depression performance measure
Measured: 12 months
Secondary outcomes (1)
cost-effectiveness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionSep 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 (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- 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
- John C. Fortney, PhD, Principal investigator, Central Arkansas Veterans Healthcare System (North Little Rock)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317018
- Sponsor's protocol ID
- IMV 04-360
- Status last verified
- Apr 2014
- First submitted
- 19 Apr 2006
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortney JC, Pyne JM, Smith JL, Curran GM, Otero JM, Enderle MA, McDougall S. Steps for implementing collaborative care programs for depression. Popul Health Manag. 2009 Apr;12(2):69-79. doi: 10.1089/pop.2008.0023.
PubMed 19320606Fortney JC, Enderle MA, Clothier JL, Otero JM, Williams JS, Pyne JM. Population level effectiveness of implementing collaborative care management for depression. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):455-60. doi: 10.1016/j.genhosppsych.2013.04.010. Epub 2013 May 30.
PubMed 23725825Fortney JC, Pyne JM, Steven CA, Williams JS, Hedrick RG, Lunsford AK, Raney WN, Ackerman BA, Ducker LO, Bonner LM, Smith JL. A Web-based clinical decision support system for depression care management. Am J Manag Care. 2010 Nov;16(11):849-54.
PubMed 21348556Fortney J, Enderle M, McDougall S, Clothier J, Otero J, Altman L, Curran G. Implementation outcomes of evidence-based quality improvement for depression in VA community based outpatient clinics. Implement Sci. 2012 Apr 11;7:30. doi: 10.1186/1748-5908-7-30.
PubMed 22494428
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Telemedicine-Based Collaborative Care for MDD in Contract CBOCs
- ClinicalTrials.gov ID
- NCT00317018
- Acronym / sponsor ID
- IMV 04-360
- Conditions
- Depression
- Keywords
- depression, quality improvement, implementation, translation, evidence-based practice, collaborative care, adoption, sustainability
- 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
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Apr 2006 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Evidence-Based Quality ImprovementImplementation Group |
| Arm 2 | No intervention | –Control Group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- veteran
- depression
- patient at Little Rock VAMC, Loma Linda VAMC, or Greater Los Angeles VAMC
Key exclusion criteria (3 listed)
- veteran
- depression
- patient at Little Rock VAMC, Loma Linda VAMC, or Greater Los Angeles VAMC
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 |
|---|---|---|
| Evidence-Based Quality ImprovementThe 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. | Behavioural | Arm 1 |
Primary outcome
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
1 secondary outcome
cost-effectiveness
Time frame: 12 months
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 28 Apr 2014.
- Results publication: PubMed 19320606Fortney JC, Pyne JM, Smith JL, Curran GM, Otero JM, Enderle MA, McDougall S. Steps for implementing collaborative care programs for depression. Popul Health Manag. 2009 Apr;12(2):69-79. doi: 10.1089/pop.2008.0023.
- Results publication: PubMed 23725825Fortney JC, Enderle MA, Clothier JL, Otero JM, Williams JS, Pyne JM. Population level effectiveness of implementing collaborative care management for depression. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):455-60. doi: 10.1016/j.genhosppsych.2013.04.010. Epub 2013 May 30.
- Results publication: PubMed 21348556Fortney JC, Pyne JM, Steven CA, Williams JS, Hedrick RG, Lunsford AK, Raney WN, Ackerman BA, Ducker LO, Bonner LM, Smith JL. A Web-based clinical decision support system for depression care management. Am J Manag Care. 2010 Nov;16(11):849-54.
- Results publication: PubMed 22494428Fortney J, Enderle M, McDougall S, Clothier J, Otero J, Altman L, Curran G. Implementation outcomes of evidence-based quality improvement for depression in VA community based outpatient clinics. Implement Sci. 2012 Apr 11;7:30. doi: 10.1186/1748-5908-7-30.
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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.
John C. Fortney, PhD principal investigator
Central Arkansas Veterans Healthcare System (North Little Rock)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Quality Improvement in people with Depression, run by US Department of Veterans Affairs at 2 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 3 inclusion and 3 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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). 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 NCT00317018, which also lists 4 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 28 Apr 2014; AzTrials last refreshed its copy on 28 Oct 2026.