Effective Implementation of Stress Treatments in US Department of Veterans Affairs PTSD Clinics

ISRCTN	ISRCTN65119065
DOI	https://doi.org/10.1186/ISRCTN65119065
Secondary identifying numbers	CRE 18-002

Submission date: 19/07/2018
Registration date: 25/07/2018
Last edited: 21/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The US Department of Veterans Affairs (VA) uses two evidence-based psychotherapies for Post-traumatic Stress Disorder (PTSD) throughout the VA healthcare system. However, the problem is that the majority of Veterans diagnosed with PTSD do not receive one of these evidence-based psychotherapies. This project aims to address this. In this two-year quality improvement project we will look the effectiveness of an intervention to address this gap in treatment.

Who can participate?
The intervention will be tested in two VA outpatient PTSD teams from different US geographic regions that have a significant quality gap in terms of delivery of evidence-based psychotherapy to veterans with PTSD. These two intervention sites will be matched to three comparison sites each for a total of two intervention and six comparison sites.

What does the study involve?
The intervention was designed in collaboration with VA leaders who have responsibility for mental health care for VA patients with PTSD. It includes six months of toolkit-guided external facilitation to help PTSD teams improve patient access to evidence-based psychotherapies for PTSD. External facilitation involves clinicians working with an expert, knowledgeable individual to make changes to their practice to improve the quality gap, including strategies and resources to improve access to psychotherapies for PTSD. To see if our intervention works, we will examine changes in the proportion of therapy patients with PTSD who receive an evidence based psychotherapy in our intervention and comparison sites.

What are the possible benefits and risks of participating?
The benefit of participating is improved access to evidence-based psychotherapies for PTSD in the two intervention VA PTSD teams, improving their rates of delivery of these proven psychotherapy. This will further benefit and support the VA mission, improving processes of care. There are no known risks to the sites for participation.

Where is the study run from?
The study is run from the Minneapolis VA Healthcare System in Minneapolis, MN and involves 8 VA Medical Centers.

When is the study starting and how long is it expected to run for?
June 2017 to March 2020

Who is funding this study?
VA Health Services Research and Development (HSR&D) (USA)

Who is the main contact?
Nina A. Sayer, PhD
nina.sayer@va.gov

Contact information

Dr Nina Sayer
Scientific

Minneapolis VA Health Care System
One Veterans Drive
Minneapolis
55417
United States of America

Phone	6124674623
Email	nina.sayer@va.gov

Study information

Study design	Interventional non-randomised proof-of-concept improvement project with a quasi-experimental, pre-post design with non-equivalent control groups
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	A Quasi-Experimental Implementation Trial of Toolkit Guided External Facilitation to Improve Reach of Evidence-Based Psychotherapies for Posttraumatic Stress Disorder (PTSD) in US Department of Veterans Affairs PTSD Clinics
Study acronym	PERSIST 2.0
Study objectives	The Primary aim of this Quality Improvement Implementation Trial is to increase the reach of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) in two low reach PTSD teams using external facilitation and a toolkit that bundles strategies and resources to improve reach identified through prior research. To achieve our primary aim, we will assess the effectiveness of our implementation strategy in a pre-post nonequivalent control group, quasi-experimental design. Our second aim is to conduct formative evaluation to inform facilitation activities and aid in interpretation of quantitative findings. Our third aim is to refine our implementation tools for use in future efforts to improve reach of CPT and PE to patients with PTSD.
Ethics approval(s)	The Minneapolis VA Health Care System IRB reviewed this project and determined that the activities involved do not meet the definition of research. This project is designed for internal purposes in support of the mission of the Department of Veterans Affairs and findings are to be used within Department of Veterans Affairs to improve processes of care. All data collected pertain to quality improvement activities. 30/06/2017
Health condition(s) or problem(s) studied	Post-traumatic Stress Disorder (PTSD)
Intervention	The study will have 2 intervention sites and 6 comparison sites. The 2 intervention sites will engage in toolkit-guided external facilitation for 6 months. Each intervention site will be matched to 3 comparison sites based on available administrative data on reach of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) (the outcome), facility and patient characteristics. External facilitation involves having an external expert in implementation with credible knowledge about the clinical innovation interact with the target sites in the context of a supportive interpersonal relationship to enact changes. Facilitation activities include assessment of local context, identifying and preparing a local champion, engagement of stakeholders, assistance in goal setting and action planning using a formal implementation plan, regular contact to provide technical assistance, formative evaluation, support and training for the internal change agent and preparing for sustainability. This work will be guided by a toolkit which bundles strategies and resources to improve access to evidence based therapies for PTSD that have been identified through prior research. The 6 comparison sites will receive assistance and support for delivery of CPT and PE as usual.
Intervention type	Behavioural
Primary outcome measure	Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) reach to therapy patients seen by the PTSD team, measured as the proportion of veterans diagnosed with PTSD during a psychotherapy appointment with a provider on the PTSD team within the 6 months before and after the intervention who receive at least one CPT or PE appointment.
Secondary outcome measures	Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) reach in other mental health teams in the facility, measured as the proportion of veterans diagnosed with PTSD during a psychotherapy appointment with a provider in any other mental health team within the 6 months before and after the intervention who receive at least one CPT or PE appointment.
Overall study start date	05/06/2017
Completion date	31/03/2020

Eligibility

Participant type(s)	Other
Age group	Not Specified
Sex	Not Specified
Target number of participants	Two Department of Veterans Affairs PTSD teams from sites in different geographic regions of the US
Key inclusion criteria	1. Low reach PTSD team (defined as less than or equal to the national median of reach on PTSD teams during a 12-month period preceding project start) 2. Have a champion to serve as an internal change agent 3. Facility leadership support for the project
Key exclusion criteria	PTSD teams that treat fewer than 500 patients in a 12 month period
Date of first enrolment	01/04/2018
Date of final enrolment	01/08/2018

Locations

Countries of recruitment

United States of America

Study participating centre

Minneapolis VA Health Care System

One Veterans Drive
Minneapolis
55417
United States of America

Sponsor information

VA Health Services Research and Development Service
Research organisation

810 Washington Ave, NW
Washington DC
20420
United States of America

"ROR"	https://ror.org/011qyt180

Funders

Funder type

Not defined

Department of Veterans Affairs Health Services Research and Development (USA)

No information available

Results and Publications

Intention to publish date	01/08/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available, as the data is available for the US Department of Veterans Affairs to improve the quality of care. Therefore, public disclosure of the data would be inconsistent with the purpose of this work.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2020	21/09/2020	Yes	No

Editorial Notes

21/09/2020: Publication reference added.
09/09/2020: The acronym has been added.