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])

Overview

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Principal Investigator:
Dr. Doug Zatzick

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: Stephen O’Connor, PhD (NIMH)

Project Scientist: Brett Hagman, PhD (National Institute of Alcohol Abuse and Alcoholism [NIAAA])

ClinicalTrials.gov Identifier: NCT02655354

Study Locations: 24 locations across the United States

Trial Status: Completed

Study Snapshot

Trial Summary

Study question and significance: Every year, 2.5 million to 3.0 million people in the United States experience an injury severe enough to require hospitalization. Many patients have symptoms of posttraumatic stress disorder (PTSD) and may have associated comorbid conditions, such as depressive symptoms and alcohol and drug use disorders. Few multicenter studies have evaluated the effectiveness of early interventions for traumatically injured patients with symptoms of PTSD.

Design and setting: Stepped-wedge, cluster randomized clinical trial with 635 hospitalized adult survivors of physical injury at 25 level I trauma centers in the United States between January 2016 and November 2018.

Intervention and methods: After an initial screen of the electronic health record to identify patients with a high likelihood of PTSD distress, followed by a formal screen using the PTSD Checklist (PCL-C), patients with high levels of distress underwent randomization, baseline evaluation, and follow-up interviews at 3, 6, and 12 months. Patients in the control group received usual care plus nurse notification about the patient’s high level of distress. Patients in the intervention group received collaborative care consisting of evidence-based medication, cognitive behavioral therapy, and case management. Patients in the intervention group whose PTSD symptoms persisted after initial treatment received stepped-up care, such as medication adjustments or additional psychotherapeutic elements. The primary outcome was PTSD symptoms measured by the PCL-C at 3, 6, and 12 months after the injury. Prespecified subgroup analyses examined effects of baseline risk factors on enduring PTSD symptoms and the relationship between the quality of protocol implementation and study outcomes.

Findings: After 6 months, but not at 3 or 12 months, the intervention group experienced a significant reduction in PTSD symptoms as compared with the control group. The treatment effect was greater for patients with higher baseline PTSD risk and for patients treated at sites with good or excellent protocol implementation. The subgroup of patients who had firearm injuries and who were treated at sites with good or excellent protocol implementation had among the largest 6-month treatment effects and had significant treatment effects at 12 months.

Conclusions and relevance: A stepped collaborative care intervention was associated with significant PTSD symptom reductions at 6 months. Greater baseline risk for PTSD and good or excellent protocol implementation were associated with greater treatment effects.

NIH Project Information

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Dr. Zatzick discusses the Trauma Survivors Outcomes and Support (TSOS) NIH Collaboratory Trial.

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