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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone monitoring
Treatment-As-Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring telemedicine, treatment compliance, mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  • VA Medical Center, Battle Creek
  • VA Western New York Healthcare System, Buffalo, NY
  • VA Medical Center, Coatesville
  • VA Puget Sound Health Care System, Tacoma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telephone Monitoring

Treatment-As-Usual

Arm Description

Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.

Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.

Outcomes

Primary Outcome Measures

Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms
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
Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program

Secondary Outcome Measures

Depressive Symptoms, Subjective Quality of Life
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)

Full Information

First Posted
February 6, 2006
Last Updated
March 22, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00288860
Brief Title
Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
Acronym
TCM-PTSD
Official Title
Telephone Case Monitoring for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
telemedicine, treatment compliance, mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
837 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Monitoring
Arm Type
Experimental
Arm Description
Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.
Arm Title
Treatment-As-Usual
Arm Type
Active Comparator
Arm Description
Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Telephone monitoring
Intervention Description
Three months of biweekly telephone monitoring and support
Intervention Type
Other
Intervention Name(s)
Treatment-As-Usual
Intervention Description
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
Primary Outcome Measure Information:
Title
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms
Description
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)
Time Frame
12 months post-discharge (8 months post intervention)
Title
Rehospitalization
Description
Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program
Time Frame
12 months post discharge
Secondary Outcome Measure Information:
Title
Depressive Symptoms, Subjective Quality of Life
Description
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)
Time Frame
12 months post-discharge (8 months post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig S. Rosen, PhD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Facility Name
VA Medical Center, Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
Facility Name
VA Western New York Healthcare System, Buffalo, NY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
VA Medical Center, Coatesville
City
Coatesville
State/Province
Pennsylvania
ZIP/Postal Code
19320
Country
United States
Facility Name
VA Puget Sound Health Care System, Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23117443
Citation
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. doi: 10.1176/appi.ps.201200142.
Results Reference
result
PubMed Identifier
23047625
Citation
Belsher BE, Tiet QQ, Garvert DW, Rosen CS. Compensation and treatment: disability benefits and outcomes of U.S. veterans receiving residential PTSD treatment. J Trauma Stress. 2012 Oct;25(5):494-502. doi: 10.1002/jts.21747. Epub 2012 Oct 9.
Results Reference
result

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

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