- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105885
Telephone Care as a Substitute for Routine Psychiatric Medication (Telepsych)
February 6, 2014 updated by: US Department of Veterans Affairs
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?
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
324
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vermont
-
White River Junction, Vermont, United States, 05009-0001
- VA Medical & Regional Office Center, White River
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
NO_INTERVENTION: Arm 2
Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Continuous
|
Continuous
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: baseline, 6 months, 12 months, 18 months, 24 months
|
baseline, 6 months, 12 months, 18 months, 24 months
|
|
SF12V and brief symptom checklist scores
Time Frame: baseline, 6 months, 18 months, 24 months
|
baseline, 6 months, 18 months, 24 months
|
|
patient medication compliance
Time Frame: two month intervals
|
two month intervals
|
|
provider satisfaction
Time Frame: baseline, midpoint, and end of study
|
baseline, midpoint, and end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amy E. Wallace, MD MPH, VA Medical & Regional Office Center, White River
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (ACTUAL)
September 1, 2008
Study Completion (ACTUAL)
September 1, 2008
Study Registration Dates
First Submitted
March 17, 2005
First Submitted That Met QC Criteria
March 17, 2005
First Posted (ESTIMATE)
March 18, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
February 10, 2014
Last Update Submitted That Met QC Criteria
February 6, 2014
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEL 01-146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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