Decision Aid in Veterans With Posttraumatic Stress Disorder
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Decision Aid in Veterans With Posttraumatic Stress Disorder|
- Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Satisfaction with care and compliance with care, score on the Survey of Health Experiences [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Use of evidence based treatments and overall cost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Behavioral: Decision Aid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908440
|Contact: Maha H Zayed, PHD||802-295-9363 ext 5918||Maha.Zayed@va.gov|
|United States, Vermont|
|White River Junction VAMC||Not yet recruiting|
|White River Junction, Vermont, United States, 05009|
|Principal Investigator:||Bradley V Watts, MD, MPH||White River Junction VAMC|
|Principal Investigator:||Paula Schnurr, PHD||White River Junction VAMC|