- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105690
TEAM Study to Improve Depression Care in Rural CBOCs
April 6, 2015 updated by: US Department of Veterans Affairs
Telemedicine Intervention to Improve Depression Care in Rural CBOCs
We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND / RATIONALE: Implementing collaborative care for depression in small rural Primary Care (PC) practices without on-site mental health specialists presents unique challenges.
We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by PC providers in small rural practices.
The Telemedicine Enhanced Antidepressant Management (TEAM) collaborative care intervention was implemented by offsite personnel and all intervention components were implemented using telemedicine technologies.
OBJECTIVE(S): Specific Aim 1: Determine whether the TEAM intervention improves quality and outcomes compared to usual care.
Specific Aim 2: Determine whether the TEAM intervention will be cost-effective in routine practice settings.
METHODS: Seven VISN 16 CBOCs participated in the study.
CBOCs were included if they 1) treated >1,000 and <5,000 unique veterans, 2) had no on-site psychiatrists, and 3) had interactive video equipment.
Matched CBOCs were randomized to receive the intervention or usual care.
Of the 24,882 clinic patients, 73.6% (n=18,306) were successfully screened and 6.9% screened positive for depression (PHQ9 =12).
Of those eligible for the study, 91.3% agreed to participate, and 91.9% of those attended their appointment and were consented.
Over an 18-month period, 395 patients were enrolled, and 91.1% (n=360) were followed-up at six months.
Telephone research interviews were conducted at baseline, six and twelve months.
Effectiveness was tested using an intent-to-treat analysis.
Cost-effectiveness analysis was assessed from the perspective of the VA.
Costs included intervention costs, encounter costs, and medication costs.
Quality Adjusted Life Years (QALYs) were calculated using the Quality of Well Being Scale.
Study Type
Interventional
Enrollment (Anticipated)
400
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
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Arkansas
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No. Little Rock, Arkansas, United States, 72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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Louisiana
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Shreveport, Louisiana, United States, 71101
- Overton Brooks VA Medical Center, Shreveport, LA
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Mississippi
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Jackson, Mississippi, United States, 39216
- G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
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-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
PHQ9 Score > or = to 12
Exclusion Criteria:
A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
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Secondary Outcome Measures
Outcome Measure |
|---|
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1) Satisfaction with care, 2) service utilization, 3) Cost, 4) Cost-effectiveness
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey M. Pyne, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
- Principal Investigator: John C. Fortney, PhD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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
- Davis TD, Deen T, Bryant-Bedell K, Tate V, Fortney J. Does minority racial-ethnic status moderate outcomes of collaborative care for depression? Psychiatr Serv. 2011 Nov;62(11):1282-8. doi: 10.1176/ps.62.11.pss6211_1282.
- Fortney 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.
- Fortney JC, Pyne JM, Edlund MJ, Mittal D. Relationship between antidepressant medication possession and treatment response. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):377-9. doi: 10.1016/j.genhosppsych.2010.03.008. Epub 2010 May 4.
- Pyne JM, Fortney JC, Tripathi SP, Maciejewski ML, Edlund MJ, Williams DK. Cost-effectiveness analysis of a rural telemedicine collaborative care intervention for depression. Arch Gen Psychiatry. 2010 Aug;67(8):812-21. doi: 10.1001/archgenpsychiatry.2010.82.
- Mittal D, Fortney JC, Pyne JM, Wetherell JL. Predictors of persistence of comorbid generalized anxiety disorder among veterans with major depressive disorder. J Clin Psychiatry. 2011 Nov;72(11):1445-51. doi: 10.4088/JCP.10m05981blu. Epub 2010 Dec 14.
- Fortney JC, Pyne JM, Edlund MJ, Stecker T, Mittal D, Robinson DE, Henderson KL. Reasons for antidepressant nonadherence among veterans treated in primary care clinics. J Clin Psychiatry. 2011 Jun;72(6):827-34. doi: 10.4088/JCP.09m05528blu. Epub 2010 Nov 16.
- Deen TL, Fortney JC, Pyne JM. Relationship between satisfaction, patient-centered care, adherence and outcomes among patients in a collaborative care trial for depression. Adm Policy Ment Health. 2011 Sep;38(5):345-55. doi: 10.1007/s10488-010-0322-z.
- Edlund MJ, Fortney JC, Reaves CM, Pyne JM, Mittal D. Beliefs about depression and depression treatment among depressed veterans. Med Care. 2008 Jun;46(6):581-9. doi: 10.1097/MLR.0b013e3181648e46.
- Mittal D, Fortney JC, Pyne JM, Edlund MJ, Wetherell JL. Impact of comorbid anxiety disorders on health-related quality of life among patients with major depressive disorder. Psychiatr Serv. 2006 Dec;57(12):1731-7. doi: 10.1176/ps.2006.57.12.1731.
- Fortney JC, Pyne JM, Edlund MJ, Robinson DE, Mittal D, Henderson KL. Design and implementation of the telemedicine-enhanced antidepressant management study. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):18-26. doi: 10.1016/j.genhosppsych.2005.07.001.
- Fortney JC, Maciejewski ML, Tripathi SP, Deen TL, Pyne JM. A budget impact analysis of telemedicine-based collaborative care for depression. Med Care. 2011 Sep;49(9):872-80. doi: 10.1097/MLR.0b013e31821d2b35.
- Fortney 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.
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
April 1, 2003
Study Completion (Actual)
October 1, 2004
Study Registration Dates
First Submitted
March 16, 2005
First Submitted That Met QC Criteria
March 16, 2005
First Posted (Estimate)
March 17, 2005
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 00-078
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