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.

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

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