TEAM Study to Improve Depression Care in Rural CBOCs
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 16, 2005 | ||||||||
| Last Updated Date | August 1, 2012 | ||||||||
| Start Date ICMJE | April 2003 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life, 5) Satisfaction with care | ||||||||
| Change History | Complete list of historical versions of study NCT00105690 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
1) Satisfaction with care, 2) service utilization, 3) Cost, 4) Cost-effectiveness [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
1) Satisfaction with care, 2) service utilization, 3) Cost, 4) Cost-effectiveness | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | TEAM Study to Improve Depression Care in Rural CBOCs | ||||||||
| Official Title ICMJE | Telemedicine Intervention to Improve Depression Care in Rural CBOCs | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE | Behavioral: Telemedicine intervention | ||||||||
| Study Arm (s) | Arm 1
Intervention: Behavioral: Telemedicine intervention |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Completion Date | October 2004 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: PHQ9 Score > or = to 12 Exclusion Criteria: A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00105690 | ||||||||
| Other Study ID Numbers ICMJE | IIR 00-078 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | September 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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