Stepped collaborative care versus American College of Surgeons Committee on Trauma required screening and referral for posttraumatic stress disorder: Clinical trial protocol

Tanya Knutzen; Eileen Bulger; Matt Iles-Shih; Alexandra Hernandez; Allison Engstrom; Lauren Whiteside; Navneet Birk; Khadija Abu; Jake Shoyer; Cristina Conde; Paige Ryan; Jin Wang; Joan Russo; Patrick Heagerty; Larry Palinkas; Douglas Zatzick

doi:10.1016/j.cct.2023.107380

Stepped collaborative care versus American College of Surgeons Committee on Trauma required screening and referral for posttraumatic stress disorder: Clinical trial protocol

Contemp Clin Trials. 2024 Jan:136:107380. doi: 10.1016/j.cct.2023.107380. Epub 2023 Nov 10.

Authors

Tanya Knutzen¹, Eileen Bulger², Matt Iles-Shih³, Alexandra Hernandez⁴, Allison Engstrom⁵, Lauren Whiteside⁶, Navneet Birk⁷, Khadija Abu⁸, Jake Shoyer⁹, Cristina Conde¹⁰, Paige Ryan¹¹, Jin Wang¹², Joan Russo¹³, Patrick Heagerty¹⁴, Larry Palinkas¹⁵, Douglas Zatzick¹⁶

Affiliations

¹ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
² Department of Surgery, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
³ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
⁴ Department of Surgery, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
⁵ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
⁶ Department of Emergency Medicine, University of Washington School of Medicine, Seattle, Washington, USA. Electronic address: [email protected].
⁷ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
⁸ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
⁹ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
¹⁰ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
¹¹ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
¹² Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
¹³ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].
¹⁴ Department of Biostatistics, University of Washington School of Public Health, Seattle, USA. Electronic address: [email protected].
¹⁵ Herbert Wertheim School of Public Health and Longevity Science, University of California, San Diego, USA. Electronic address: [email protected].
¹⁶ Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, USA. Electronic address: [email protected].

Abstract

Background: Each year in the US, approximately 1.5-2.5 million individuals are so severely injured that they require inpatient hospital admissions. The American College of Surgeons Committee on Trauma (College) now requires that trauma centers have in place protocols to identify and refer hospitalized patients at risk injury psychological sequelae. Literature review revealed no investigations that have identified optimal screening, intervention, and referral procedures in the wake of the College requirement.

Methods: The single-site pragmatic trial investigation will individually randomize 424 patients (212 intervention and 212 control) to a brief stepped care intervention versus College required mental health screening and referral control conditions. Blinded follow-up interviews at 1-, 3-, 6-, and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The emergency department information exchange (EDIE) will be used to capture population-level automated emergency department and inpatient utilization data for the intent-to-treat sample. The investigation 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 study incorporates a Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) implementation process assessment.

Conclusions: The overarching goal of the investigation is to advance the sustainable delivery of high-quality trauma center mental health screening, intervention, and referral procedures for diverse injury survivors. An end-of-study policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high-quality acute care mental health screening, intervention and referral services for diverse injured patient populations.

Trial registration: Clinicaltrials.govNCT05632770.

Keywords: Emergency department utilization; Policy; Posttraumatic stress disorder; Rapid qualitative assessment procedures; Trauma centers; Traumatic injury.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Comorbidity
Humans
Pragmatic Clinical Trials as Topic
Randomized Controlled Trials as Topic
Referral and Consultation
Stress Disorders, Post-Traumatic* / diagnosis
Stress Disorders, Post-Traumatic* / epidemiology
Stress Disorders, Post-Traumatic* / therapy
Surgeons*
Trauma Centers
United States

Associated data

ClinicalTrials.gov/NCT05632770

Abstract

Publication types

MeSH terms

Associated data

Grants and funding