Clinical trial NCT00105885: Telephone Care as a Substitute for Routine Psychiatric Medication
Official title: Telephone Care as a Substitute for Routine Psychiatric Medication Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Posttraumatic Stress Disorders
Anxiety Disorders
Keywords: Telephone
Telemedicine
Psychopharmacology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-03-18
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Healthcare utilization (VHA and non-VHA patient visits); patient time spent obtaining care (including travel time); time provider spends in direct patient care.
timeFrame: Continuous
Secondary outcomes:
measure: 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
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
measure: SF12V and brief symptom checklist scores
timeFrame: baseline, 6 months, 18 months, 24 months
measure: patient medication compliance
timeFrame: two month intervals
measure: provider satisfaction
timeFrame: baseline, midpoint, and end of study
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: VA Medical & Regional Office Center, White River
state: Vermont
Study officials:
affiliation: VA Medical & Regional Office Center, White River
name: Amy E. Wallace, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.