Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD) (TCM-PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00288860
First received: February 6, 2006
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to test whether providing PTSD patients additional support by telephone (in addition to usual outpatient care) after they discharge from residential treatment improves those patients' outcomes and keeps them out of the hospital longer.


Condition Intervention
Stress Disorders, Post-Traumatic
Behavioral: Telephone case monitoring
Other: Treatment as Usual Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Telephone Case Monitoring for Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • a) violence, substance use, PTSD symptoms; b) time to rehospitalization; c) costs [ Time Frame: 4 and 12 months post-discharge (1-8 months post intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • d) depressive symptoms, subjective quality of life [ Time Frame: 4 and 12 months post-discharge (1-8 months post intervention) ] [ Designated as safety issue: No ]

Enrollment: 926
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Telephone monitoring as augmentation to treatment as usual
Behavioral: Telephone case monitoring
Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)
Active Comparator: Arm 2
Treatment as usual
Other: Treatment as Usual Control
Usual outpatient mental health care (psychotherapy and/or medications)

Detailed Description:

Background: Sporadic outpatient treatment attendance contributes to high rates of relapse and rehospitalization among veterans with posttraumatic stress disorder (PTSD). Telephone case monitoring has improved treatment adherence and reduced relapse among patients with chronic medical and substance use disorders, but has not been previously tested in PTSD patients. Pilot research by our group indicates the intervention is feasible, acceptable to patients, and reduces time from discharge to completion of a first outpatient visit.

Objectives: The proposed multisite randomized controlled trial will test whether providing telephone monitoring to PTSD patients after discharge from residential treatment improves retention in aftercare, thereby improving patient functioning and reducing psychiatric rehospitalization. Major objectives are to determine whether telephone monitoring results in a) improved clinical outcomes (less violence, substance use, and PTSM symptoms; and b) longer time to rehospitalization. This study will also assess how telephone case monitoring impacts costs of care.

Methods: This study will be a multisite randomized controlled trial. A total of 900 subjects will be recruited from 7 PTSD residential treatment programs (one women's program and seven programs serving predominantly men) located at 6 VA medical centers. All patients completing at least 4 days of residential PTSD treatment and discharging to VA outpatient care will be eligible to participate. Within each site, subjects will be randomized to receive either usual referral to outpatient mental health care after discharge OR usual outpatient mental health care plus telephone case monitoring. Subjects in the telephone monitoring condition will receive biweekly telephone calls during the first three months after discharge to encourage treatment adherence and provide problem-solving support. Patient demographics and baseline clinical assessments will be collected by questionnaire at intake. Patients will be surveyed by mail 4 and 12 months after discharge to assess psychiatric symptoms, substance use, and violence. VA inpatient and outpatient treatment utilization data will be obtained from the VA National Patient Care Database. If patients receive care from Vet Centers, their Vet Center counselors will also be surveyed to quantify patient use of outpatient care. Primary intent-to-treat analyses will use hierarchical linear modeling to compare the one-year course of substance use, violence, PTSD symptoms, and depression symptoms in the telephone monitoring and usual care groups. Survival analysis will be used to compare conditions on time to rehospitalization. Cost-outcome analyses will compare costs associated with the intervention relative to usual care and estimate costs per unit of improved outcome. Secondary analyses will assess whether differences in outcomes between the telephone case monitoring and usual care groups are mediated by improved attendance in outpatient care.

Status: Roughly 600 subjects have been recruited from 5 study sites; half have received the case monitoring intervention. Recruitment is continuing.

Department of Defense PTSD/TBI Intramural Research Award will fund a second study extending this intervention to a broader population of VA outpatients; that study began in Sept 08.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a PTSD diagnosis entering PTSD residential treatment with an intended length of stay of 15 days or longer (patients in brief evaluation or acute stabilization tracks will not be included, as their discharge plan may include readmission to residential treatment within a few months).

Exclusion Criteria:

  1. Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);
  2. Active Duty military personnel;
  3. Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;
  4. Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288860

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
United States, Michigan
VA Medical Center, Battle Creek
Battle Creek, Michigan, United States, 49015
United States, New York
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
United States, Pennsylvania
VA Medical Center, Coatesville
Coatesville, Pennsylvania, United States, 19320
United States, Washington
VA Puget Sound Health Care System, Tacoma
Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Investigators
Principal Investigator: Craig S. Rosen, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00288860     History of Changes
Other Study ID Numbers: TEL 03-135
Study First Received: February 6, 2006
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
telemedicine
treatment compliance
mental health

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014