Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03663452 |
| Other study ID # |
ROS0029 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2019 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Palo Alto Veterans Institute for Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will evaluate a program designed to increase military treatment facilities' use of
Prolonged Exposure (PE), an evidence-based psychotherapy for PTSD. The results will determine
whether this program increases PE use and improves patient outcomes compared to conventional
provider training in PE, and feedback from clinic leaders and staff will be used to gauge
program usability, identify successful components, and refine program for expansion.
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
