Telephone Care as a Substitute for Routine Psychiatric Medication

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Telephone Care as a Substitute for Routine Psychiatric Medication Management

Conditions
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Major Depression, Posttraumatic Stress Disorders, Anxiety Disorders

Intervention / Treatment
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* Procedure: telephone care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible for this study if they carry a diagnosis of major depression, Post-traumatic Stress Disorder (PTSD), or non-PTSD anxiety disorders. They must be psychiatrically stable subjects with a Global Assessment of Functioning scale score of >50, no psychiatric hospitalizations in the previous six months, and no active substance abuse disorders. Exclusion Criteria: Psychiatric hospitalization within 6 months prior to study entry. Visit interval >1 year. Lack of telephone access. Inability to use a telephone. GAF<50.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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. | Procedure: telephone care<br>* 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.<br>|
| No Intervention: Arm 2<br>Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilization (VHA and non-VHA patient visits); patient time spent obtaining care (including travel time); time provider spends in direct patient care. |  | Continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| SF12V and brief symptom checklist scores |  | baseline, 6 months, 18 months, 24 months | 
| patient medication compliance |  | two month intervals | 
| provider satisfaction |  | baseline, midpoint, and end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telephone, Telemedicine, Psychopharmacology