Telephone Care as a Substitute for Routine Psychiatric Medication

NCT ID: NCT00105885

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2008-09-30

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.

Conditions

Major Depression; Posttraumatic Stress Disorders; Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

telephone care

Intervention Type: PROCEDURE

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 2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy E. Wallace, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Medical & Regional Office Center, White River

Locations

VA Medical & Regional Office Center, White River

White River Junction, Vermont, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19061681 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19264942 (View on PubMed)

Other Identifiers

TEL 01-146

Identifier Type: -

Identifier Source: org_study_id