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):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00288860
First received: February 6, 2006
Last updated: March 22, 2016
Last verified: March 2016
  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 monitoring
Other: Treatment-As-Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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 VA Office of Research and Development:

Primary Outcome Measures:
  • Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms [ Time Frame: 12 months post-discharge (8 months post intervention) ] [ Designated as safety issue: No ]

    Higher scores are worse outcomes on all four measures:

    Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)


  • Rehospitalization [ Time Frame: 12 months post discharge ] [ Designated as safety issue: Yes ]
    Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program


Secondary Outcome Measures:
  • Depressive Symptoms, Subjective Quality of Life [ Time Frame: 12 months post-discharge (8 months post intervention) ] [ Designated as safety issue: No ]
    Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)


Enrollment: 837
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: Telephone Monitoring
Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.
Behavioral: Telephone monitoring
Three months of biweekly telephone monitoring and support
Other: Treatment-As-Usual
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
Active Comparator: Treatment-As-Usual
Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.
Other: Treatment-As-Usual
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)

Detailed Description:

Background: Poor compliance with aftercare may contribute to high rates of relapse and rehospitalization among Veterans who received residential treatment for posttraumatic stress disorder (PTSD). Telephone case monitoring has been shown to improve treatment adherence and reduced relapse among patients with chronic medical and substance use disorders, but has not been tested in PTSD patients.

Objectives: This multisite randomized controlled trial tested whether augmenting usual aftercare with telephone monitoring improved resulted in 1) improved clinical outcomes (less violence, substance use, and PTSD symptoms; 2) longer time to rehospitalization; 3) better compliance with aftercare in the year after discharge from residential treatment for PTSD.

Methods: This trial recruited 837 subjects from 6 PTSD residential treatment programs at 5 VA medical centers, 94.7% of the 884 projected. Patients who completed at least 14 days of residential PTSD treatment and discharged to VA outpatient care were eligible to participate. Subjects were randomized to usual aftercare care (n = 425) or usual aftercare plus biweekly telephone case monitoring calls during the first three months after discharge (n = 412). Telephone case monitors assessed current problems, encouraged treatment adherence, provided problem-solving support, and alerted providers to emergent care needs. Patient self-report measures of psychiatric symptoms, substance use, and violence were obtained at intake to residential treatment and 4 months (69% completion rate) and 12 months (64% completion rate) after discharge. Retention was lower than the investigators' planned 70% to 75% rate due to difficulty locating some patients who moved (even their collateral informants did not know where they were) and 45 participants asking to discontinue due to lack of time (n = 10), general dissatisfaction with VA (n = 6), distress during phone calls (n = 5), dissatisfaction with compensation (n = 1), or no specified reason (n = 24). Treatment utilization data was obtained from the VA National Patient Care Database.

Intent-to-treat analyses used mixed modeling to compare clinical outcomes in the telephone monitoring and usual care groups and 4 and 12 months after discharge. Survival analysis was used to compare conditions on time to rehospitalization. Having a slightly smaller-than-intended sample size resulted in modest reductions in statistical power, e.g., power to detect the expected d = .25 effect on PTSD outcomes was reduced from about 90% to 82%, and power to detect the anticipated W = .105 difference in rehospitalization rates was reduced from 88% to 85%. Secondary analyses assessed whether differences in outcomes between the telephone case monitoring and usual care groups were mediated by attending more outpatient visits and completing more medication refills. Exploratory analyses examined whether the effect of telephone support on the clinical outcome measures, number of treatment visits, and medication refills was moderated by number of outpatient mental health visits in the prior year, distance from clinic, treatment expectancies, therapeutic alliance, or co-occurring substance use problems.

Status: Enrollment, intervention, data collection, and primary analyses are completed. Primary results have been published in Psychiatric Services (Rosen, Tiet, Harris et al., 2013) and two secondary papers have been published in the Journal of Traumatic Stress (Belsher, Tiet, Garvert, & Rosen, 2012; Rosen, Adler, & Tiet, 2013).

A CDMRP-funded study extending this approach to PTSD outpatients at the Durham, Puget Sound and Palo Alto VA medical centers has recently been completed. Initial results of that second trial suggest that telephone care management improved treatment attendance but had weak effects on outcomes.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
VA Office of Research and Development
Investigators
Principal Investigator: Craig S. Rosen, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00288860     History of Changes
Other Study ID Numbers: TEL 03-135 
Study First Received: February 6, 2006
Results First Received: October 3, 2014
Last Updated: March 22, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
telemedicine
treatment compliance
mental health

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Trauma and Stressor Related Disorders

ClinicalTrials.gov processed this record on May 26, 2016