Clinical trial NCT05632770: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Physical Injury
Keywords: PTSD
Physical Injury
Emergency Department Utilization
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-12-01
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.

Detailed description: 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) 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 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 1-, 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 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 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 (RAPICE) 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 for diverse patient populations.

Eligibility criteria: Inclusion Criteria:

* Injured patients ≥18 years of age
* Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen
* Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) .
* Speak English and/or Spanish

Exclusion Criteria:

* Age \<18
* Not admitted for a traumatic injury
* Speak a language other than English and/or Spanish
* Acutely suicidal/admitted for a suicide attempt
* Cognitively impaired
* Incarcerated
* Acutely psychotic
* Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada
* Less than 2 pieces of contact information
* Prior history of violence, such that study staff may not be safe
* Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition
* Most recent COVID-19 test positive

Primary outcomes:
measure: Posttraumatic Stress Disorder (PTSD) symptoms change over time
timeFrame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
measure: Emergency department utilization change over time
timeFrame: Baseline injury admission to 12-months post-injury follow-up
Secondary outcomes:
measure: Alcohol use change over time
timeFrame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
measure: Mental and physical functioning change over time
timeFrame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
measure: Depression symptoms change over time
timeFrame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
measure: Suicide risk assessment change over time
timeFrame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
measure: Substance use change over time
timeFrame: Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Douglas Zatzick, MD
role: PRINCIPAL_INVESTIGATOR
References: