UH3 Project: A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS])
Principal Investigator: Douglas Zatzick, MD
Gregory Jurkovich, MD, Trauma Surgery Policy Lead
Patrick Heagerty, PhD, Biostatistics Lead
Joan Russo, PhD, Psychometrics Lead
Erik Van Eaton, MD, Bioinformatics Lead
Doyanne Darnell, PhD, Behavioral Therapy Lead
Sponsoring Institution: University of Washington School of Medicine
NIH Institute Providing Oversight: National Institute of Mental Health (NIMH)
Program Official: Jane Pearson (NIMH)
Project Scientist: Brett Hagman (National Institute of Alcohol Abuse and Alcoholism [NIAAA])
ClinicalTrials.gov Identifier: NCT02655354
Study Locations: 24 locations across the United States
Trial Status: Currently recruiting participants
Each year, more than 30 million Americans present to trauma centers, emergency departments, and other acute-care settings (i.e., trauma care systems) for treatment of physical injuries. Multiple long-term conditions, including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptoms, and preexisting long-term medical conditions are endemic among survivors of physical trauma, including those with and without traumatic brain injuries (TBIs). PTSD and related comorbid conditions are associated with marked functional impairments and societal costs. Evidence-based treatments for PTSD and comorbidity exist but have yet to be broadly implemented throughout U.S. trauma care systems. The challenges presented by this constellation of PTSD and comorbid conditions in survivors of both TBI and non-TBI injuries require novel research approaches that cut across the traditional domains of multiple NIH Institutes.
The TSOS project will enable a series of innovations in the efficient development and implementation of a large-scale, policy-relevant, pragmatic randomized clinical trial targeting PTSD and comorbidity for injured patients cared for at U.S. trauma centers. The trial will be conducted at 24 level 1 trauma care centers across the United States.