UH3 Project: A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS])

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

Co-Investigators:

  • 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 injury. 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.

NIH Project Information

Presentation

5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)

Interview

10/27/2017: Interview with principal investigator Dr. Doug Zatzick (PDF)

Supplementary Material

Regulatory and Ethics Support Documentation

8/19/2014: Trauma Care and PTSD Project UH2 Milestones

Publications

Evaluation of a Level I trauma center provider training in alcohol brief intervention delivery within a 25-site trial of screening and intervention for PTSD and related comorbidity. Trauma Surg Acute Care Open. 2019;4:e000370.

Pragmatic quality assessment of brief health behavior change interventions: evidence for criterion-related validity of the Behavior Change Counseling Index. J Clin Med Res. 2019;11(11):764-768.

Ethical and regulatory considerations for using social media platforms to locate and track research participants. Am J Bioeth. 2019;19(6):47-61.

Ethical and regulatory considerations for using social media platforms to locate and track research participants. Am J Bioeth. 2019;19(6):47-61.

Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in pragmatic clinical trials of mental health services implementation: methods and applied case study. Adm Policy Ment Health. 2018;46(2):255-270.

Task-shifting to improve the reach of mental health interventions for trauma patients: findings from a pilot study of trauma nurse training in patient-centered activity scheduling for PTSD and depression. Cogn Behav Ther. 2019;48(6):482-496.

The cumulative burden of mental, substance use, and general medical disorders and rehospitalization and mortality after an injury. Psychiatr Serv. 2017;68(6):596-602.

An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity. Implement Sci. 2016 Apr 30;11:58.

Presentations and Interviews

5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)

5/14/2018: Presentation to NIH Collaboratory Steering Committee (slides)

10/27/2017: Interview with principal investigator Dr. Doug Zatzick (PDF)

5/23/2017: Presentation on Top Barriers/Challenges and Recent Generalizable Lessons Learned to NIH Collaboratory Steering Committee (slides)

5/9/2016: Presentation on Data Governance and Data Sharing to NIH Collaboratory Steering Committee (slides)

5/9/2016: Presentation on Generalizable Lessons Learned to NIH Collaboratory Steering Committee (slides)

4/8/2016: PCT Grand Rounds: Design and Early Implementation (video; slides)

5/28/2015: Interview with principal investigator Dr. Doug Zatzick (video)

4/21/2015: Presentation to NIH Collaboratory Steering Committee (slides)

2/20/2015: PCT Grand Rounds (video; slides)

8/19/2014: Interview with principal investigator Dr. Doug Zatzick (video)

8/19/2014: Presentation at NIH Collaboratory Steering Committee (slides)

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Citation:

Demonstration Projects: UH3 Project: A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS]). In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/demonstration-projects/uh3-project-a-policy-relevant-u-s-trauma-care-system-pragmatic-trial-for-ptsd-and-comorbidity-trauma-survivors-outcomes-and-support-tsos/. Updated January 10, 2020.