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

NCT ID: NCT05632770

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2027-10-31

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.

Conditions

PTSD; Physical Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stepped Collaborative Care (Intervention)

Patients in the intervention condition will receive a stepped collaborative care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements targeting posttraumatic stress disorder (PTSD) and related comorbidity.

Group Type: EXPERIMENTAL

Stepped Collaborative Care

Intervention Type: BEHAVIORAL

Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral.

Group Type: ACTIVE_COMPARATOR

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

Intervention Type: BEHAVIORAL

The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35.

Interventions

Stepped Collaborative Care

Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.

Intervention Type: BEHAVIORAL

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Douglas Zatzick

Professor, Psychiatry & Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Zatzick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Douglas Zatzick, MD

Role: CONTACT

dzatzick@uw.edu

206-744-6701

Tanya Knutsen, MSW

Role: CONTACT

206-406-1273

Facility Contacts

Douglas Zatzick, MD

Role: primary

dzatzick@uw.edu

206-744-6701

Allison Engstrom, MSW

Role: backup

alliengs@uw.edu

(206) 406-1273

References

Knutzen T, Bulger E, Iles-Shih M, Hernandez A, Engstrom A, Whiteside L, Birk N, Abu K, Shoyer J, Conde C, Ryan P, Wang J, Russo J, Heagerty P, Palinkas L, Zatzick D. 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.

Reference Type: DERIVED

PMID: 37952714 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH130460

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00015632

Identifier Type: -

Identifier Source: org_study_id