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

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105885
  Purpose

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?


Condition Intervention
Major Depression
Posttraumatic Stress Disorders
Anxiety Disorders
Procedure: telephone care

MedlinePlus related topics:   Anxiety    Depression    Post-Traumatic Stress Disorder    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Telephone Care as a Substitute for Routine Psychiatric Medication Management

Further study details as provided by Department of Veterans Affairs:

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. [ Time Frame: Continuous ] [ Designated as safety issue: No ]

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 [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
  • SF12V and brief symptom checklist scores [ Time Frame: baseline, 6 months, 18 months, 24 months ] [ Designated as safety issue: No ]
  • patient medication compliance [ Time Frame: two month intervals ] [ Designated as safety issue: No ]
  • provider satisfaction [ Time Frame: baseline, midpoint, and end of study ] [ Designated as safety issue: No ]

Enrollment:   324
Study Start Date:   November 2003
Study Completion Date:   September 2008
Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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
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.
2: No Intervention
Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105885

Locations
United States, Vermont
VA Medical & Regional Office Center    
      White River Junction, Vermont, United States, 05009-0001

Sponsors and Collaborators

Investigators
Principal Investigator:     Amy E. Wallace, MD MPH     VA Medical & Regional Office Center, White River    
  More Information


Responsible Party:   Department of Veterans Affairs ( Wallace, Amy - Principal Investigator )
Study ID Numbers:   TEL 01-146
First Received:   March 17, 2005
Last Updated:   October 15, 2008
ClinicalTrials.gov Identifier:   NCT00105885
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Telephone  
Telemedicine  
Psychopharmacology  

Study placed in the following topic categories:
Depression
Anxiety Disorders
Mental Disorders
Mood Disorders
Stress Disorders, Post-Traumatic
Stress
Depressive Disorder, Major
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 20, 2008




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