UH3 Project: A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS])
Overview
Principal Investigator:
Co-Investigators:
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Gregory Jurkovich, MD, Trauma Surgery Policy Lead
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Patrick Heagerty, PhD, Biostatistics Lead
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Joan Russo, PhD, Psychometrics Lead
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Erik Van Eaton, MD, Bioinformatics Lead
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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
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.
Data and Resource Sharing
- TSOS Data Dictionary
TSOS Data Dictionary
- TSOS Protocol
TSOS Protocol
- TSOS Data Quality and Phenotyping Manual
TSOS Data Quality and Phenotyping Manual
- TSOS Consent Form
TSOS Consent Form
- TSOS_Zatzick_UH3_Follow-up
TSOS UH3 Ethics and Regulatory Documentation Follow-up
- Zatzick TSOS Reg-Ethics Minutes Suppl Material
TSOS UH2 Ethics and Regulatory Documentation
Featured Interviews
Dr. Zatzick discusses the Trauma Survivors Outcomes and Support (TSOS) NIH Collaboratory Trial.
News and Interviews
- News_Racial and Ethnic Minority Injury Survivors See Greater Improvement in PTSD Symptoms in the TSOS Study
February 6, 2024: Racial and Ethnic Minority Injury Survivors See Greater Improvements in PTSD Symptoms in the TSOS Study
- News_Your Pragmatic Trial Has Ended Now What
January 22, 2024: Your Pragmatic Trial Has Ended. Now What?
- News_Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
- News_TSOS Implements Suicide Assessment and Monitoring Method in Pragmatic Clinical Trial
April 11, 2022: TSOS Implements Suicide Assessment and Monitoring Method in Pragmatic Clinical Trial
- News_A Year of New Insights From the NIH Collaboratory
December 14, 2021: A Year of New Insights From the NIH Collaboratory
- News_TSOS GR
August 4, 2021: PCT Grand Rounds Presents Results of the TSOS Trial
- News_TSOS GR presentation of findings
June 8, 2021: PCT Grand Rounds to Feature Results of the TSOS Trial
- News_TSOS Findings
March 11, 2021: TSOS Study Intervention Reduces PTSD Symptoms in Injured Patients at Level I Trauma Centers
- News_A Year of Results and New Insights From the NIH Collaboratory
December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory
- News_TSOS_COVID
October 22, 2020: TSOS Study Team Describes Impacts of a COVID-19 Surge on Delivery of Acute Care and Emergency Services
Publications
- Abu et al Trauma Surg Acute Care Open 2024
Can stepped collaborative care interventions improve post-traumatic stress disorder symptoms for racial and ethnic minority injury survivors?
- Palinkas et al Adm Policy Ment Health 2022
Rapid ethnographic assessment of the impact of the COVID-19 pandemic on mental health services delivery in an acute care medical emergency department and trauma center
- Nguyen et al Trauma Surg Acute Care Open 2022
Post-traumatic stress disorder (PTSD) symptoms and alcohol and drug use comorbidity at 25 US level I trauma centers
- Bulger et al J Am Coll Surg 2022
Nationwide survey of trauma center screening and intervention practices for posttraumatic stress disorder, firearm violence, mental health, and substance use disorders
- Whiteside et al J Subst Abuse Treat 2022
The Emergency Department Longitudinal Integrated Care (ED-LINC) intervention targeting opioid use disorder: a pilot randomized clinical trial
- Engstrom et al Psychiatry 2022
A pragmatic clinical trial approach to assessing and monitoring suicidal ideation: results from a national US trauma care system study
- Zatzick et al Med Care 2021
Catalyzing the translation of patient-centered research into United States trauma care systems: a case example
- Nehra et al Ann Surg 2021
A prospective US national trauma center study of firearm injury survivors weapon carriage and posttraumatic stress disorder symptoms
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- TSOS Study Snapshot
TSOS Study Snapshot
- Zatzick et al JAMA Surg 2021
TSOS Main Outcome Paper
- Whiteside et al Trauma Surg Acute Care Open 2021
Leveraging a health information exchange to examine the accuracy of self-report emergency department utilization data among hospitalized injury survivors
- Palinkas et al BMJ Open 2020
Rapid ethnographic assessment of the COVID-19 pandemic April 2020 'surge' and its impact on service delivery in an acute care medical emergency department and trauma center
- Roberts et al Ethics Hum Res 2020
Ethical and regulatory concerns in pragmatic clinical trial monitoring and oversight
- Moodliar et al Psychiatry 2020
A pragmatic approach to psychometric comparisons between the DSM-IV and DSM-5 Posttraumatic Stress Disorder (PTSD) Checklists in acutely injured trauma patients
- Living Textbook Chapter_Pragmatic Implementation Process Assessments
Living Textbook Chapter: Dissemination and Implementation: Pragmatic Implementation Process Assessments
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_How Are PRO Measures Used
Living Textbook: How are PRO Measures Used?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- Moloney et al Psychiatry 2020
Experiences and insights from the early US COVID-19 epicenter: a Rapid Assessment Procedure Informed Clinical Ethnography case series
- Darnell et al Trauma Surg Acute Care Open 2019
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
- Darnell et al J Clin Med Res 2019
Pragmatic quality assessment of brief health behavior change interventions: evidence for criterion-related validity of the Behavior Change Counseling Index
- Bhatia-Lin et al Am J Bioeth 2019
Ethical and regulatory considerations for using social media platforms to locate and track research participants
- Palinkas and Zatzick Adm Policy Ment Health 2018
Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in pragmatic clinical trials of mental health services implementation: methods and applied case study
- Living Textbook Chapter_Data Sharing and Embedded Research
Living Textbook Chapter: Data Sharing Solutions for Embedded Research
- Darnell et al Cogn Behav Ther 2018
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
- TSOS 2017-Snapshot
TSOS 2017-Snapshot
- Living Textbook Chapter_Changes to Policy and Guidelines
Living Textbook Chapter: Dissemination and Implementation: Changes to Policy and Guidelines
- Living Textbook Chapter_Case Study_Planning for Monitoring PCTs
Living Textbook Chapter: Data and Sefety Monitoring:Case Study: Planning for Monitoring PCTs
- Living Textbook Chapter_Identifying the Study Population
Living Textbook Chapter: Using EHR Data in PCTs - Identifying the Study Population
Presentations
- 2023 NIH Workshop_Panel 2_Bulger
2023 NIH Workshop Panel 2: Bulger
- 2023 NIH Workshop_Panel 1_Zatzick_Bulgar
2023 NIH Workshop Panel 1: Zatzick, Bulgar
- 2022 NIH Workshop_Zatzick
2022 NIH Workshop TSOS Presentation
- 2022 NIH Workshop_Zatzick_Day 2
2022 NIH Workshop TSOS Presentation Day 2
- GR-Video-06-11-21
The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results (GR Video 2021)
- GR-Slides-06-11-21
The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results (GR Slides 2021)
- GR-Video-05-29-20
EHR Core Workshop: Experiences from the Collaboratory PCTs (GR Video 2020)
- GR-Slides-05-29-20
EHR Core Workshop: Experiences from the Collaboratory PCTs (GR Slides 2020)
- Presentations at the April 2020 SC Meeting
Presentations at the April 2020 SC Meeting
- SC-2019-Barriers-TSOS
Barriers and Challenges-TSOS
- Workshop Design and Analysis of PCT_Panel 3_Choosing a Parallel Group or Stepped-Wedge Design
Workshop Design and Analysis of PCT: Panel 3: Choosing a Parallel Group or Stepped-Wedge Design
- GR-Video-04-19-19
Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims (GR Video 2019)
- GR-Slides-04-19-19
The Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial: Revisiting Effectiveness & Implementation Aims (GR Slides 2019)
- Presentation_TSOS_AHR_2018_c
Harnessing Policy Capacity to Pragmatically Implement Hybrid Trial Findings in US Trauma Care Systems (AcademyHealth 2018)
- 5.-Zatzick_TSOS-Barriers-Lessons-Learned_FINAL
Trauma Survivors Outcomes & Support: Progress, Barriers, and Lessons Learned
- GR-Video-04-20-18
The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study (GR Video 2018)
- GR-Slides-4-20-18
The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study (GR Slides 2018)
- Topic 8-Dissemination
ePCT Workshop Topic 8-Dissemination
- Introduction to Case Studies
Introduction to Case Studies
- Topic 3-Implementation
ePCT Workshop Topic 3-Implementation
- Topic 1-Embedded PCTs
ePCT Workshop Topic 1-Embedded PCTs
- Presentation_TSOS_DI_2017_c
Developing Clinical Ethnographic Implementation Science Methods for RAPID Assessments in Acute Care PCTs (D&I 2017)
- Poster_TSOS_DI_2017_c
Developing Clinical Ethnographic Implementation Science Methods for RAPID Assessments in Acute Care PCTs (D&I 2017)
- Zatzick-SC-May-2017
Trauma Survivors Outcomes & Support: Barriers, Challenges & Lessons Learned
- Panel 1 Setting the Stage for Dissemination and Implementation
Dissemination and Implementation Workshop Panel 1: Setting the Stage for Dissemination and Implementation
- GR-Video-04-14-17
Toward National Trauma Care Practice Change for PTSD & Comorbidity: Lessons Learned from the TSOS Pragmatic Trial (GR Video 2017)
- GR-Slides-04-14-17
Toward National Trauma Care Practice Change for PTSD & Comorbidity: Lessons Learned from the TSOS Pragmatic Trial (GR Slides 2017)
- Workshop_Panel 2_Oversight of Pragmatic Clinical Trials
Workshop: Ethical and Regulatory Issues of PCTs: Panel 2: Oversight of Pragmatic Clinical Trials: Institutional Review Boards and Data and Safety Monitoring Boards
- Zatzick_5-5-16 TSOS Final UH3 MCC Presentation
The Trauma Survivors Outcomes & Support: UH2-UH3 Lessons Learned
- Zatzick5-5-16 Final TSOS Data Sharing
The Trauma Survivors Outcomes & Support (TSOS) Study: Data Sharing Considerations