- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680524
Telephone-based Care for OEF/OIF Veterans With PTSD
Telephone Based Care for OIF/OEF Veterans With PTSD
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PTSD
- Operation Enduring Freedom and Operation Iraqi Freedom veteran
Exclusion Criteria:
- no phone
- severe brain injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Phone Based Outreach Intervention Group
Open pilot trial
|
Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability to Providers and Patients
Time Frame: Six months
|
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
|
Six months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bradford L. Felker, MD BA, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHP 08-184
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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