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Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings

Primary Purpose

Posttraumatic Stress Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS)
Prolonged exposure training
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Posttraumatic Stress Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provides behavioral health care to PTSD patients

Exclusion Criteria:

  • Plans to relocate within next 5 months

Sites / Locations

  • Bassett Army Community Hospital / Ft. Wainwright
  • Mental Health Clinic / Travis Air Force Base
  • Naval Hospital Jacksonville / Naval Air Station Jacksonville
  • Blanchfield Army Community Hospital (BACH) / Fort Campbell
  • 81st Medical Group / Keesler Air Force Base
  • 49th Medical Group / Holloman Air Force Base
  • William Beaumont Army Medical Center (WBAMC) / Fort Bliss
  • Brooke Army Medical Center (BAMC) / Fort Sam Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prolonged exposure training

TACTICS

Arm Description

Outcomes

Primary Outcome Measures

PE use
The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data

Secondary Outcome Measures

Change in patients' PTSD severity
Patients' PTSD symptoms, as measured by change on a PTSD symptom measure routinely collected at behavioral health appointments.

Full Information

First Posted
September 4, 2018
Last Updated
June 5, 2023
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03663452
Brief Title
Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings
Official Title
Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This project will use a cluster-randomized stepped wedge design in eight MHS behavioral health outpatient clinics. All sites first receive PE training, and are randomly allocated to receive the TACTICS intervention either 5, 10, or 15 months later.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prolonged exposure training
Arm Type
Active Comparator
Arm Title
TACTICS
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged exposure training
Intervention Description
Providers will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation.
Primary Outcome Measure Information:
Title
PE use
Description
The proportion of PTSD patients who receive PE, as measured by coded electronic medical record data
Time Frame
Baseline to 20 months
Secondary Outcome Measure Information:
Title
Change in patients' PTSD severity
Description
Patients' PTSD symptoms, as measured by change on a PTSD symptom measure routinely collected at behavioral health appointments.
Time Frame
Baseline to 20 months
Other Pre-specified Outcome Measures:
Title
TACTICS usability and satisfaction
Description
Usability of and overall satisfaction with TACTICS among senior leaders, clinic leaders, and providers, as assessed through post-TACTICS qualitative interviews.
Time Frame
Immediately after the 5-month TACTICS intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provides behavioral health care to PTSD patients Exclusion Criteria: Plans to relocate within next 5 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen McLean, PhD
Organizational Affiliation
carmen.mclean4@va.gov
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bassett Army Community Hospital / Ft. Wainwright
City
Fairbanks
State/Province
Alaska
ZIP/Postal Code
99703
Country
United States
Facility Name
Mental Health Clinic / Travis Air Force Base
City
Fairfield
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
Naval Hospital Jacksonville / Naval Air Station Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32214
Country
United States
Facility Name
Blanchfield Army Community Hospital (BACH) / Fort Campbell
City
Fort Campbell North
State/Province
Kentucky
ZIP/Postal Code
42223
Country
United States
Facility Name
81st Medical Group / Keesler Air Force Base
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39530
Country
United States
Facility Name
49th Medical Group / Holloman Air Force Base
City
Alamogordo
State/Province
New Mexico
ZIP/Postal Code
88330
Country
United States
Facility Name
William Beaumont Army Medical Center (WBAMC) / Fort Bliss
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States
Facility Name
Brooke Army Medical Center (BAMC) / Fort Sam Houston
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32330670
Citation
Rosen CS, Davis CA, Riggs D, Cook J, Peterson AL, Young-McCaughan S, Comtois KA, Haddock CK, Borah EV, Dondanville KA, Finley EP, Jahnke SA, Poston WSC, Wiltsey-Stirman S, Neitzer A, Broussard CR, Brzuchalski MA, Clayton MSP, Conforte LAM, Flores A, Hein J, Keith CF, Jinkerson CJ, Letendre M, Nofziger D, Pollick K, Santiago CK, Waggoner LCJ, Woodworth C, McLean CP; TACTICS Research Group. Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study. Contemp Clin Trials. 2020 Jun;93:106008. doi: 10.1016/j.cct.2020.106008. Epub 2020 Apr 21.
Results Reference
derived

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Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings

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