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Telephone Care as a Substitute for Routine Psychiatric Medication (Telepsych)

Primary Purpose

Major Depression, Posttraumatic Stress Disorders, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telephone care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Telephone, Telemedicine, Psychopharmacology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Medical & Regional Office Center, White River

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm Description

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.

Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval.

Outcomes

Primary Outcome Measures

Healthcare utilization (VHA and non-VHA patient visits); patient time spent obtaining care (including travel time); time provider spends in direct patient care.

Secondary Outcome Measures

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
SF12V and brief symptom checklist scores
patient medication compliance
provider satisfaction

Full Information

First Posted
March 17, 2005
Last Updated
February 6, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00105885
Brief Title
Telephone Care as a Substitute for Routine Psychiatric Medication
Acronym
Telepsych
Official Title
Telephone Care as a Substitute for Routine Psychiatric Medication Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Posttraumatic Stress Disorders, Anxiety Disorders
Keywords
Telephone, Telemedicine, Psychopharmacology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval.
Intervention Type
Procedure
Intervention Name(s)
telephone care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Time Frame
baseline, 6 months, 12 months, 18 months, 24 months
Title
SF12V and brief symptom checklist scores
Time Frame
baseline, 6 months, 18 months, 24 months
Title
patient medication compliance
Time Frame
two month intervals
Title
provider satisfaction
Time Frame
baseline, midpoint, and end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy E. Wallace, MD MPH
Organizational Affiliation
VA Medical & Regional Office Center, White River
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical & Regional Office Center, White River
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19061681
Citation
Pomerantz A, Cole BH, Watts BV, Weeks WB. Improving efficiency and access to mental health care: combining integrated care and advanced access. Gen Hosp Psychiatry. 2008 Nov-Dec;30(6):546-51. doi: 10.1016/j.genhosppsych.2008.09.004. Epub 2008 Oct 5.
Results Reference
result
PubMed Identifier
19264942
Citation
Morden NE, Mistler LA, Weeks WB, Bartels SJ. Health care for patients with serious mental illness: family medicine's role. J Am Board Fam Med. 2009 Mar-Apr;22(2):187-95. doi: 10.3122/jabfm.2009.02.080059.
Results Reference
result

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Telephone Care as a Substitute for Routine Psychiatric Medication

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