Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD) (TCM-PTSD)
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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 |
- 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 ]
- 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 |
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:
- Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);
- Active Duty military personnel;
- Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;
- Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.
Contacts and Locations| United States, Arkansas | |
| Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | |
| 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 | |
| Principal Investigator: | Craig S. Rosen, PhD | VA Palo Alto Health Care System |
More Information
No publications provided
| 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: | January 24, 2013 |
| 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 June 17, 2013