Telephone Care as a Substitute for Routine Psychiatric Medication (Telepsych)
Tracking Information | |||||
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First Received Date ICMJE | March 17, 2005 | ||||
Last Updated Date | April 23, 2012 | ||||
Start Date ICMJE | November 2003 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Healthcare utilization (VHA and non-VHA patient visits); patient time spent obtaining care (including travel time); time provider spends in direct patient care. [ Time Frame: Continuous ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00105885 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Patient satisfaction at baseline, midpoint, end of study; provider satisfaction at baseline, midpoint, end of study; patient medication compliance; SF12V and brief symptom checklist scores (baseline, 6 months, 12 months, 18 months, 24 months) | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Telephone Care as a Substitute for Routine Psychiatric Medication | ||||
Official Title ICMJE | Telephone Care as a Substitute for Routine Psychiatric Medication Management | ||||
Brief Summary | The purpose of this study is to answer the following questions: (1) Does substituting brief, scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric medication management visits reduce overall healthcare utilization? (2) Is substituting brief, scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric medication management visits as effective as routine care? |
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Detailed Description | Telemedicine uses communications technologies to provide health care when distance separates participants. Applied to general medical care practice, telemedicine is associated with improved continuity of care, cost-effectiveness, and improved service quality. To date, all evaluations of telepsychiatry have concentrated on video technology. The telephone is more readily available and less expensive communication technology that has not been evaluated as a method of health services delivery in the medication management of stable psychiatric outpatients. We will enroll 346 psychiatrically stable subjects, who carry a diagnosis of major depression, post-traumatic stress disorder (PTSD) or non-PTSD anxiety disorder. We will use a balanced randomization strategy to assign subjects to routine care or telephone care for a two-year period within each provider panel. Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval. Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinic visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval. At two years, we will use ten data sources to compare two primary outcomes (total VHA health services utilization and mental health component scores from the SF-12-V) as well as VHA costs, imputed non-VHA costs, patient and provider satisfaction, medication compliance and diagnosis specific outcomes. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: telephone care
Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinical visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval. |
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Study Arm (s) |
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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 | ||||
Enrollment ICMJE | 324 | ||||
Completion Date | September 2008 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | NCT00105885 | ||||
Other Study ID Numbers ICMJE | TEL 01-146 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Department of Veterans Affairs | ||||
Study Sponsor ICMJE | Department of Veterans Affairs | ||||
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Investigators ICMJE |
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Information Provided By | Department of Veterans Affairs | ||||
Verification Date | October 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |