- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663452
Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings
Study Overview
Status
Conditions
Detailed Description
Background: Posttraumatic stress disorder (PTSD) is a significant problem in the military, impacting as many as 1 in 5 military personnel. Efforts to disseminate evidence-based treatments for PTSD such as Prolonged Exposure (PE) therapy throughout the Military Health System (MHS) have relied primarily on provider training. These have yielded mixed results, because they do not directly address barriers that may prevent providers from using a new treatment after they gave been trained in it. Barriers to using PE within the MHS are complex and exist at various levels of organization from the provider level to the "outer context" (i.e., higher headquarter policies, guidelines). In addition, barriers may vary considerably from one military treatment facility to another. Thus, implementation strategies to improve use of PE need to be tailored to conditions in each clinic site.
Objectives: The primary objective is to develop and implement a novel approach, Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS), to improve the implementation of PE and to test its impact on care over and above clinician training only. TACTICS provides a menu of implementation strategies that can be matched to local conditions. These strategies are informed by the implementation science literature and by prior experience working with military clinics, The TACTICS process begins with a mixed methods assessment (using data from medical records, staff surveys, and staff interviews) to identify barriers and facilitators of PE use in each clinic. Implementation strategies are then selected in collaboration with clinic personnel and deployed to address specific barriers and leverage strengths at each clinic site.
Specific Aims: 1) To examine the impact of a multi-modal, tailored approach (TACTICS) over and above conventional PE training on the proportion of PTSD patients who receive PE for PTSD, as measured by Natural Language Processing (NLP) of psychotherapy progress notes (primary measure) and clinician-selected psychotherapy modality (secondary measure). 2) To examine the impact of TACTICS over and above conventional PE training on mean improvement in Military Treatment Facility (MTF) clinic patients' scores on the PTSD Checklist (PCL) for DSM-5 (fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, PCL-5). 3) To evaluate the usability of and overall satisfaction with TACTICS among senior leaders, clinic leaders, and providers, as assessed by qualitative data obtained from the post-TACTICS feedback interviews. The study will also aim to identify TACTICS components that a) were seen as most useful by participants and appear to contribute to implementation success; b) are potentially helpful but require modifications; and c) are potentially unnecessary and do not appear to contribute to implementation success. Exploratory aims include: A) To assess the impact of TACTICS (over and above PE training) on provider and clinic-level factors theorized to facilitate implementation in the Consolidated Framework for Implementation Research (CFIR). These proximal factors include changes in provider knowledge/beliefs about PE, provider self-efficacy, burnout, implementation climate, and leadership engagement, as assessed through online surveys. B) To explore whether changes in additional CFIR-theorized provider- and clinic-level factors (based on emergent themes in qualitative needs assessment interviews and exit interviews) are associated with greater improvements in reach (i.e., a greater number of patients receiving PE) and effectiveness (i.e., greater improvement in PTSD symptoms as measured by the PCL-5). C) To examine the TACTICS implementation strategies employed at each site in connection with increase in PE receipt, to determine whether any particular strategies had a positive or negative impact on PE receipt. D) To evaluate the impact of TACTICS over and above conventional PE training on self-reported levels of PE fidelity, as measured by NLP data of psychotherapy progress notes. E) To examine patient characteristics (e.g., depression, generalized anxiety, recent hospitalizations, other psychiatric diagnoses) that may be associated with PE receipt.
Study Design. This project will use a cluster-randomized stepped wedge design in eight MHS behavioral health outpatient clinics. Randomization will occur at the clinic level to account for the clustering of providers within clinics. All clinics receive the whole intervention package, but timing is randomly assigned. Participants will include the behavioral health providers and relevant clinic and hospital leadership. During a baseline phase, provider training in PE will be delivered. During the second phase, a clinic-based needs assessment will be conducted followed by the implement of TACTICS components. Selection of implementation strategies will be guided by the results of the needs assessments and well-established implementation science frameworks. Results of the second phase will determine the impact of TACTICS over and above clinician training.
Significance. Accelerating the use of PE for PTSD within the MHS will increase the number of service members in need who can access, and hopefully benefit, from an effective PTSD treatment. In turn, as more patients recover successfully, behavioral health clinic capacity will increase and more service members will receive care. The project will identify solutions for the unique challenges to implementation of PE in the MHS, and, if effective, TACTICS may represent a scalable approach to accelerating the use of other behavioral health best practices in military settings
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alaska
-
Fairbanks, Alaska, United States, 99703
- Bassett Army Community Hospital / Ft. Wainwright
-
-
California
-
Fairfield, California, United States, 94535
- Mental Health Clinic / Travis Air Force Base
-
-
Florida
-
Jacksonville, Florida, United States, 32214
- Naval Hospital Jacksonville / Naval Air Station Jacksonville
-
-
Kentucky
-
Fort Campbell North, Kentucky, United States, 42223
- Blanchfield Army Community Hospital (BACH) / Fort Campbell
-
-
Mississippi
-
Biloxi, Mississippi, United States, 39530
- 81st Medical Group / Keesler Air Force Base
-
-
New Mexico
-
Alamogordo, New Mexico, United States, 88330
- 49th Medical Group / Holloman Air Force Base
-
-
Texas
-
El Paso, Texas, United States, 79920
- William Beaumont Army Medical Center (WBAMC) / Fort Bliss
-
San Antonio, Texas, United States, 78234
- Brooke Army Medical Center (BAMC) / Fort Sam Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provides behavioral health care to PTSD patients
Exclusion Criteria:
- Plans to relocate within next 5 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Prolonged exposure training
|
Providers will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation.
|
|
Experimental: TACTICS
|
TACTICS begins with a mixed methods assessment (using data from medical records, staff surveys, and staff interviews) to identify barriers and facilitators of PE use in each clinic.
From a menu of implementation strategies that can be matched to local conditions, an implementation plan is developed in collaboration with clinic personnel and deployed to address specific barriers and leverage strengths at each clinic site over a 5-month period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PE use
Time Frame: Baseline to 20 months
|
The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data
|
Baseline to 20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in patients' PTSD severity
Time Frame: Baseline to 20 months
|
Patients' PTSD symptoms, as measured by change on a PTSD symptom measure routinely collected at behavioral health appointments.
|
Baseline to 20 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TACTICS usability and satisfaction
Time Frame: Immediately after the 5-month TACTICS intervention
|
Usability of and overall satisfaction with TACTICS among senior leaders, clinic leaders, and providers, as assessed through post-TACTICS qualitative interviews.
|
Immediately after the 5-month TACTICS intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carmen McLean, PhD, carmen.mclean4@va.gov
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROS0029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Posttraumatic Stress Disorder
-
University Hospital, ToursCompletedPostTraumatic Stress DisorderFrance
-
Sofie FolkeAarhus University Hospital; Copenhagen Trial Unit, Center for Clinical Intervention... and other collaboratorsNot yet recruiting
-
ARQ National Psychotrauma CentreLeiden University Medical CenterEnrolling by invitationPosttraumatic Stress Disorder (PTSD)Netherlands
-
The University of Texas Health Science Center at...University of Pennsylvania; Brooke Army Medical Center; C.R.Darnall Army Medical... and other collaboratorsCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Icahn School of Medicine at Mount SinaiCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Berlin Center for the Treatment of Torture VictimsCompletedPosttraumatic Stress Disorder (PTSD)Germany
-
TEMPVA Research Group, Inc.C.R.Darnall Army Medical Center; VA Boston Healthcare System; Central Texas Veterans...UnknownPosttraumatic Stress Disorder, Combat-relatedUnited States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Michael E. DeBakey VA Medical CenterSouth Central VA Mental Illness Research, Education & Clinical CenterCompletedPosttraumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentCompleted
Clinical Trials on Prolonged exposure training
-
University of PennsylvaniaUniversity of TexasCompleted
-
Leiden UniversityRadboud University Medical Center; ZonMw: The Netherlands Organisation for... and other collaboratorsCompletedPost Traumatic Stress DisorderNetherlands
-
The University of Texas Health Science Center at...University of Pennsylvania; Brooke Army Medical Center; C.R.Darnall Army Medical... and other collaboratorsCompletedPosttraumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress DisorderUnited States
-
United States Department of DefenseMinneapolis Veterans Affairs Medical Center; University of Minnesota; VA Palo... and other collaboratorsRecruitingPost Traumatic Stress DisorderUnited States
-
Karolinska InstitutetRegion StockholmRecruitingPost Traumatic Stress DisorderSweden
-
University of PennsylvaniaMedical University of South Carolina; U.S. Army Medical Research and Development...CompletedPosttraumatic Stress Disorder | Combat DisorderUnited States
-
Stanford UniversityNational Institutes of Health (NIH); VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
HaEmek Medical Center, IsraelWithdrawnPost Traumatic Stress Disorder | Anxiety DisorderIsrael
-
Ohio State UniversityRecruitingPTSD | Suicidal Ideation | Suicide, Attempted | Trauma, PsychologicalUnited States