NCT00105885

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 10, 2014

Status Verified

October 1, 2008

Enrollment Period

4.8 years

First QC Date

March 17, 2005

Last Update Submit

February 6, 2014

Conditions

Keywords

TelephoneTelemedicinePsychopharmacology

Outcome Measures

Primary Outcomes (1)

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

    Continuous

Secondary Outcomes (4)

  • 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

  • SF12V and brief symptom checklist scores

    baseline, 6 months, 18 months, 24 months

  • patient medication compliance

    two month intervals

  • provider satisfaction

    baseline, midpoint, and end of study

Study Arms (2)

Arm 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

Arm 2

NO INTERVENTION

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

Interventions

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 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Psychiatric hospitalization within 6 months prior to study entry.
  • Visit interval \>1 year.
  • Lack of telephone access.
  • Inability to use a telephone.
  • GAF\<50.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical & Regional Office Center, White River

White River Junction, Vermont, 05009-0001, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Depressive Disorder, MajorStress Disorders, Post-TraumaticAnxiety Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Amy E. Wallace, MD MPH

    VA Medical & Regional Office Center, White River

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2005

First Posted

March 18, 2005

Study Start

November 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 10, 2014

Record last verified: 2008-10

Locations