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Telephone-based Care for OEF/OIF Veterans With PTSD

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone-based outreach
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-Traumatic Stress Disorder focused on measuring telephone-based intervention for PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • PTSD
  • Operation Enduring Freedom and Operation Iraqi Freedom veteran

Exclusion Criteria:

  • no phone
  • severe brain injury

Sites / Locations

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phone Based Outreach Intervention Group

Arm Description

Open pilot trial

Outcomes

Primary Outcome Measures

Acceptability to Providers and Patients
Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below

Secondary Outcome Measures

Full Information

First Posted
May 16, 2008
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00680524
Brief Title
Telephone-based Care for OEF/OIF Veterans With PTSD
Official Title
Telephone Based Care for OIF/OEF Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
telephone-based intervention for PTSD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone Based Outreach Intervention Group
Arm Type
Experimental
Arm Description
Open pilot trial
Intervention Type
Other
Intervention Name(s)
Phone-based outreach
Intervention Description
Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD
Primary Outcome Measure Information:
Title
Acceptability to Providers and Patients
Description
Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PTSD Operation Enduring Freedom and Operation Iraqi Freedom veteran Exclusion Criteria: no phone severe brain injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradford L. Felker, MD BA
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Telephone-based Care for OEF/OIF Veterans With PTSD

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