April 8, 2016: The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Trial Targeting PTSD and Comorbidity
Doug Zatzick, MD, and Doyanne Darnell, PhD, of the Department of Psychiatry, University of Washington School of Medicine
The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Trial Targeting PTSD and Comorbidity: Design and Early Implementation
Pragmatic clinical trial; Stepped wedge design; Implementation science; PTSD; Trauma centers
- The TSOS trial aims to improve symptoms of PTSD and depression, suicidal ideation, substance use, and post-injury physical function.
- TSOS is a cluster-randomized trial employing a stepped-wedge design across 24 US trauma sites.
- TSOS aims to facilitate knowledge generation at the interface of pragmatic trials and implementation science. Pragmatic elements of the TSOS design include broad eligibility criteria, multiple comorbidities, flexible intervention, comparison with usual care, and an intent-to-treat primary outcome analysis.
- The trial implements stepped collaborative care involving empathic engagement, medications, behavioral intervention, specialty referral, and community integration.
- TSOS’s hybrid design informs data sharing that simultaneously targets treatment effectiveness and practice change considerations for US trauma centers.
One challenge is the scientific tension between the integrity of the stepped-wedge design and the flexibility of site implementation.
What are the complexities between an effective intervention and an effective implementation?
How do you handle generalizability of results versus trial efficiency?
For More Information
Visit the TSOS Demonstration Project’s webpage.
#TSOS; #ImplementationScience; #pctGR
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