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: February 6, 2014
Last verified: March 2012

February 6, 2006
February 6, 2014
October 2006
April 2011   (final data collection date for primary outcome measure)
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 ]
a) violence, substance use, PTSD symptoms; b) time to rehospitalization; c) costs
Complete list of historical versions of study NCT00288860 on ClinicalTrials.gov Archive Site
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 ]
d) depressive symptoms, subjective quality of life
Not Provided
Not Provided
 
Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
Telephone Case Monitoring for Veterans With PTSD

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
  • Behavioral: Telephone case monitoring
    Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)
  • Other: Treatment as Usual Control
    Usual outpatient mental health care (psychotherapy and/or medications)
  • Experimental: Arm 1
    Telephone monitoring as augmentation to treatment as usual
    Intervention: Behavioral: Telephone case monitoring
  • Active Comparator: Arm 2
    Treatment as usual
    Intervention: Other: Treatment as Usual Control
Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 Jan;64(1):13-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
926
December 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00288860
TEL 03-135
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Craig S. Rosen, PhD VA Palo Alto Health Care System
Department of Veterans Affairs
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP