Telephone-based Care for OEF/OIF Veterans With PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00680524
First received: May 16, 2008
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from depression, PTSD, or alcohol use disorders. However, evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who suffer from PTSD.

Research Plan:

This is an open trial to assess feasibility of augmenting standard treatment of PTSD with TIDES based telephone-based nurse care management.


Condition Intervention
Post-Traumatic Stress Disorder
Other: Phone-based outreach

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telephone Based Care for OIF/OEF Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Acceptability to providers and patients [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Open pilot trial
Other: Phone-based outreach
Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD

Detailed Description:

Background:

Veterans from Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) present with high rates of post-traumatic stress disorder (PTSD) and depressive disorders, but may experience barriers to specialty mental health (MH) care. Recent research suggests the majority of OEF/OIF veterans referred to MH for PTSD or depression fail to attend the recommended number of appointments within the first year. The TIDES (Translating Initiatives for Depression into Effective Solutions) model of collaborative care management for depression is an evidence-based option for VA primary care settings. However, patients in TIDES care management often have co-morbid PTSD, and the current model does not include PTSD-specific tools.

Objectives:

The primary objectives of the project were to assess feasibility and acceptability of (1) adapting TIDES tools and protocols to include PTSD and depression in the management of OEF/OIF patients, and (2) implementing the adapted model to augment treatment as usual in the VA Seattle-Puget Sound Deployment Health Clinic (DHC).

Methods:

We conducted a pilot implementation of the TIDES/PTSD model in a single site that provides integrated care specifically for OEF/OIF veterans. TIDES CPRS (Computerized Patient Record System) templates were adapted to include assessment and monitoring for PTSD. Phone-based care management protocols were expanded to include PTSD in three clinical domains: (1) medication management, (2) psychosocial support, and (3) patient self-management support, including the optional workbook "Strategies for Managing Stress After the War: Veterans Workbook." The templates were written in VA Class 1 Software, and clinical data were coded as Health Factors, allowing for automatic collection into the VISN 20 Data Warehouse. TIDES Care Managers were trained to use these templates, protocols, and workbook. Clinical staff received an orientation to the model of care. We enrolled 20 patients, newly initiating care at the DHC, who had a clinical diagnosis of PTSD and score of 50 or greater on the PTSD Check List-Military version (PCL-M). Co-morbid depression, if present, was defined by clinical diagnosis and a score of 10 or greater on the nine-item Patient Health Questionnaire (PHQ-9). Patients were followed by a Care Manager for up to six months. Formative evaluation included utilization data, clinical data, and qualitative data from semi-structured interviews of clinical staff and patients on their experiences with the model.

Status:

Final report.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PTSD
  • Operation Enduring Freedom and Operation Iraqi Freedom veteran

Exclusion Criteria:

  • no phone
  • severe brain injury
  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: NCT00680524

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: Bradford L. Felker, MD BA VA Puget Sound Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680524     History of Changes
Other Study ID Numbers: SHP 08-184
Study First Received: May 16, 2008
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
telephone-based intervention for PTSD

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

ClinicalTrials.gov processed this record on July 20, 2014