Decision Aid in Veterans With Posttraumatic Stress Disorder
Primary Purpose
Posttraumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Decision Aid, Posttraumatic Stress Disorder, evidence-based treatments
Eligibility Criteria
Inclusion Criteria:
- Veterans who meet criteria for Posttraumatic Stress Disorder on the Posttraumatic Stress Disorder Checklist (PCL).
Exclusion Criteria:
- Patients must not have active substance abuse.
- Patients must not have received VA PTSD treatment within the last 12 months.
Sites / Locations
- White River Junction VAMC
Outcomes
Primary Outcome Measures
Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire
Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale
Satisfaction with care and compliance with care, score on the Survey of Health Experiences
Secondary Outcome Measures
Use of evidence based treatments and overall cost
Full Information
NCT ID
NCT00908440
First Posted
May 20, 2009
Last Updated
May 22, 2009
Sponsor
White River Junction Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00908440
Brief Title
Decision Aid in Veterans With Posttraumatic Stress Disorder
Official Title
Decision Aid in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
White River Junction Veterans Affairs Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of a decision aid on veterans with posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary hypothesis is that patients assigned to use the decision aid will demonstrate improved quality of decisions regarding PTSD treatment relative to patients assigned to usual care. Improved decision quality will be examined by assessing patient's knowledge of treatments, evaluation of the risk and benefits, ability to arrive at a decision, and certainty about that decision. The investigators' secondary hypothesis is that patients assigned to the decision aid will be more satisfied with their care and more compliant with their care compared to patients assigned to receive usual care. The investigators will also determine whether patients assigned to the decision aid, relative to patients assigned to usual care, are more likely to receive evidence-based treatments for PTSD and experience reductions in PTSD symptoms.
Detailed Description
Posttraumatic stress is a severe and often disabling condition affecting millions of veterans. Within VA, significant staffing and financial resources are devoted to the mission of treating PTSD and the anticipated need for treatment is expected to accelerate as veterans return from the Iraq war.
Research has identified a number of successful strategies for the treatment of PTSD, including both psychotherapy and pharmacology. Several treatments, including group psychotherapy and benzodiazepines have demonstrated a lack of efficacy in the treatment of PTSD. Despite this knowledge, many veterans with PTSD do not receive an evidence-based treatment and may even receive a treatment known to not be effective. Among the group of proven effective treatments, the patient time commitment and adverse effects differ considerably. Patients with PTSD are often ill informed about the available treatments, and there has been little formal effort aimed at matching the patients' preferences to a specific treatment.
We propose to conduct a clinical trial of a decision aid for veterans with PTSD. Decision aids are standardized, evidence-based tools to help patients choose between two or more preference-sensitive, clinically acceptable options when there is no clear "best" option. Decision aids are designed to provide patients with detailed balanced information about all the viable treatment options. In addition, they seek to assist the patient in clarifying their own values and preferences such that the patient may choose among the available treatment options.
We believe that the use of a decision aid, compared to treatment as usual, will result in a more patient-centered approach that ultimately will increase the likelihood of the patient receiving evidence based care, both of which are priority goals of VHA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Decision Aid, Posttraumatic Stress Disorder, evidence-based treatments
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
25 page booklet informing patients about PTSD symptoms and treatment options
Primary Outcome Measure Information:
Title
Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire
Time Frame
1 week
Title
Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale
Time Frame
1 week
Title
Satisfaction with care and compliance with care, score on the Survey of Health Experiences
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Use of evidence based treatments and overall cost
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veterans who meet criteria for Posttraumatic Stress Disorder on the Posttraumatic Stress Disorder Checklist (PCL).
Exclusion Criteria:
Patients must not have active substance abuse.
Patients must not have received VA PTSD treatment within the last 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha H Zayed, PHD
Phone
802-295-9363
Ext
5918
Email
Maha.Zayed@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley V Watts, MD, MPH
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula Schnurr, PHD
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VAMC
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Foa, E.B., Keane, TM, Friedman, M.J. (eds): Effective treatments for PTSD: Practice guidelines from the International Society for Traumatic Stress Studies. NY, Guilford, 2000.
Results Reference
background
Citation
Watts, B., Mayo, L., Weeks, W. A meta analysis of treatments for posttraumatic stress disorder, in International Society for Traumatic Stress Studies 21st Annual meeting. Toronto, Canada, 2005.
Results Reference
background
PubMed Identifier
12804407
Citation
O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2003;(2):CD001431. doi: 10.1002/14651858.CD001431.
Results Reference
background
PubMed Identifier
15253093
Citation
Rosen CS, Chow HC, Finney JF, Greenbaum MA, Moos RH, Sheikh JI, Yesavage JA. VA practice patterns and practice guidelines for treating posttraumatic stress disorder. J Trauma Stress. 2004 Jun;17(3):213-22. doi: 10.1023/B:JOTS.0000029264.23878.53.
Results Reference
background
PubMed Identifier
26830930
Citation
Watts BV, Zayed MH, Llewellyn-Thomas H, Schnurr PP. Understanding and meeting information needs for patients with posttraumatic stress disorder. BMC Psychiatry. 2016 Feb 1;16:21. doi: 10.1186/s12888-016-0724-x.
Results Reference
derived
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Decision Aid in Veterans With Posttraumatic Stress Disorder
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