# A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2022 · $790,177

## Abstract

ABSTRACT
Life-threatening traumatic exposures requiring presentation to acute care medical settings are endemic in the
US in the era of the COVID-19 pandemic, firearm proliferation, and extreme weather events, and constitute
both a substantial source of individual suffering and a significant public health burden. Each year in the US,
over 30 million individuals present to acute care medical settings after injury, and approximately 2.5 million
individuals are so severely injured that they require inpatient hospital admissions. The overarching goal of the
Trauma Survivors Outcomes and Support (TSOS) R01 investigation is to advance the sustainable delivery of
high quality trauma center mental health screening, intervention and referral procedures for diverse injury
survivors. Over the past two decades, the TSOS study team that includes research scientists, trauma surgical
policymakers, patients, and frontline clinicians has established a track record of using evidence derived from
NIH pragmatic trials to directly target American College of Surgeons Committee on Trauma (College)
regulatory policy. The TSOS R01 investigation will refine and test optimal stepped care intervention strategies
for diverse injury survivors presenting to acute care medical settings with PTSD and associated comorbidity.
This single trauma center site pragmatic trial investigation will individually randomize 424 patients (212
intervention and 212 control) to a brief stepped care intervention versus College required screening and
referral control conditions. The stepped care intervention consists of proactive care management, as well as
medications and psychotherapy elements targeting PTSD and comorbidity. Blinded follow-up interviews at 3-,
6-, and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The
emergency department health information exchange will be used to capture population-level automated
emergency department/inpatient utilization data for the intent-to-treat sample. The R01 aims to test the primary
hypotheses that intervention patients will demonstrate significant reductions in PTSD symptoms and
emergency department/inpatient utilization when compared to control patients. The investigation will also
explore mediators and moderators of intervention treatment effects that directly address actionable national
trauma center quality improvements. A mixed method Rapid Assessment Procedure-Informed Clinical
Ethnography implementation process assessment will facilitate the integration of study results into national
College policy requirements, guidelines, and verification criteria. A national trauma center survey will elucidate
the progression of PTSD and comorbidity screening, intervention and referral for all US level I and II trauma
centers. An end-of-study College policy summit will harness pragmatic trial data to inform the capacity for US
trauma centers to implement high quality acute care medical mental health services...

## Key facts

- **NIH application ID:** 10506526
- **Project number:** 1R01MH130460-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** EILEEN M BULGER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $790,177
- **Award type:** 1
- **Project period:** 2022-09-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10506526

## Citation

> US National Institutes of Health, RePORTER application 10506526, A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems (1R01MH130460-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10506526. Licensed CC0.

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