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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105885
First received: March 17, 2005
Last updated: April 23, 2012
Last verified: October 2008

March 17, 2005
April 23, 2012
November 2003
September 2008   (final data collection date for primary outcome measure)
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 ]
  • Total VHA health services utilization
  • Mental health component scores from the SF-12-V
Complete list of historical versions of study NCT00105885 on ClinicalTrials.gov Archive Site
  • 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 ]
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)
 
 
 
Telephone Care as a Substitute for Routine Psychiatric Medication
Telephone Care as a Substitute for Routine Psychiatric Medication Management

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?

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.

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Major Depression
  • Posttraumatic Stress Disorders
  • Anxiety Disorders
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.
  • Experimental: Arm 1
    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.
    Intervention: Procedure: telephone care
  • No Intervention: Arm 2
    Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
324
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105885
TEL 01-146
No
Department of Veterans Affairs
Department of Veterans Affairs
 
Principal Investigator: Amy E. Wallace, MD MPH VA Medical & Regional Office Center, White River
Department of Veterans Affairs
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP