A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

NCT02655354 | Completed Results

• 2 other identifiers: 20150987UH3MH106338
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 24

Brief Summary

The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.

Conditions

Posttraumatic Stress Disorder; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Mild Cognitive Impairment; Quality of Life; Pain; Wounds and Injury; Brain Injuries; Chronic Disease

Outcome Measures

Primary Outcomes (4)

• Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury

  The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.

  Baseline, 3-month, 6-month, 12-month

• Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury

  The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.

  Baseline, 3-month, 6-month, 12-month

• Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury

  The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.

  Baseline, 3-month, 6-month, 12-month

• Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury

  The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.

  Baseline, 3-month, 6-month, 12-month

Secondary Outcomes (9)

• Number of Participants With Suicidal Ideation

  Baseline, 3-month, 6-month, 12-month

• Number of Participants Endorsing a Single Item That Assesses Opioid Use

  Baseline, 3-month, 6-month, 12-month

• Cognitive Impairment Scale

  Baseline, 3-month, 6-month, 12-month

• Brief Pain Inventory

  Baseline, 3-month, 6-month, 12-month

• SF-36 Quality of Life

  Baseline, 3-month, 6-month, 12-month

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.

Behavioral: Motivational Interviewing; Behavioral: Cognitive Behavioral Therapy Elements; Behavioral: Care Management; Drug: Fluoxetine; Drug: Fluvoxamine; Drug: Paroxetine; Drug: Sertraline; Drug: Citalopram; Drug: Venlafaxine; Drug: Duloxetine; Drug: Mirtazapine; Drug: Diphenhydramine; Drug: Trazodone; Drug: Prazosin

Usual Care

NO INTERVENTION

Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.

Interventions

Motivational Interviewing BEHAVIORAL

Intervention

Cognitive Behavioral Therapy Elements BEHAVIORAL

Intervention

Care Management BEHAVIORAL

Intervention

Fluoxetine DRUG

Anti-depressant

Intervention

Fluvoxamine DRUG

Anti-depressant

Intervention

Paroxetine DRUG

Anti-depressant

Intervention

Sertraline DRUG

Anti-depressant

Intervention

Citalopram DRUG

Anti-depressant

Intervention

Venlafaxine DRUG

Anti-depressant

Intervention

Duloxetine DRUG

Anti-depressant

Intervention

Mirtazapine DRUG

Anti-depressant

Intervention

Diphenhydramine DRUG

Sleep medication

Intervention

Trazodone DRUG

Sleep medication

Intervention

Prazosin DRUG

Sleep medication

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient currently admitted to inpatient/emergency department for a traumatic injury

You may not qualify if:

• Non-English speaking
• Self-inflicted injury
• Actively psychotic
• Incarcerated or in custody
• Less than 35 on PTSD Checklist
• Less than 3 items on PTSD medical record screen
• Less than 2 pieces of contact information

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (24)

Honor Health

Scottsdale, Arizona, 85251, United States

Location

Cedars Sinai

Beverly Hills, California, 90211, United States

Location

U.C. Davis

Sacramento, California, 95816, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

U.C.L.A. Harbor

Torrance, California, 90509, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Georgia Regents

Augusta, Georgia, 30912, United States

Location

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Baylor Health Care System

Dallas, Texas, 75204, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

The University of Utah

Salt Lake City, Utah, 84132, United States

Location

The University of Vermont

Burlington, Vermont, 05405, United States

Location

Inova Trauma Center

Falls Church, Virginia, 22042, United States

Location

The University of Wisconsin Madison

Madison, Wisconsin, 53715, United States

Location

Related Publications (7)

• Abu K, Bedard-Gilligan M, Moodliar R, Bulger EM, Hernandez A, Knutzen T, Shoyer J, Birk N, Conde C, Engstrom A, Ryan P, Wang J, Russo J, Zatzick DF. Can stepped collaborative care interventions improve post-traumatic stress disorder symptoms for racial and ethnic minority injury survivors? Trauma Surg Acute Care Open. 2024 Jan 24;9(1):e001232. doi: 10.1136/tsaco-2023-001232. eCollection 2024.

  PMID: 38287923 DERIVED

• Zatzick D, Palinkas L, Chambers DA, Whiteside L, Moloney K, Engstrom A, Prater L, Russo J, Wang J, Abu K, Iles-Shih M, Bulger E. Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis. Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.

  PMID: 37085877 DERIVED

• Nguyen J, Whiteside LK, Bulger EM, Veach L, Moloney K, Russo J, Nehra D, Wang J, Zatzick DF. Post-traumatic stress disorder (PTSD) symptoms and alcohol and drug use comorbidity at 25 US level I trauma centers. Trauma Surg Acute Care Open. 2022 Aug 4;7(1):e000913. doi: 10.1136/tsaco-2022-000913. eCollection 2022.

  PMID: 35979039 DERIVED

• Engstrom A, Moloney K, Nguyen J, Parker L, Roberts M, Moodliar R, Russo J, Wang J, Scheuer H, Zatzick D. A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study. Psychiatry. 2022 Spring;85(1):13-29. doi: 10.1080/00332747.2021.1991200. Epub 2021 Dec 21.

  PMID: 34932440 DERIVED

• Nehra D, Bulger EM, Maier RV, Moloney KE, Russo J, Wang J, Anderson K, Zatzick DF. A Prospective US National Trauma Center Study of Firearm Injury Survivors Weapon Carriage and Posttraumatic Stress Disorder Symptoms. Ann Surg. 2021 Oct 1;274(4):e364-e369. doi: 10.1097/SLA.0000000000005043.

  PMID: 34225296 DERIVED

• Zatzick D, Jurkovich G, Heagerty P, Russo J, Darnell D, Parker L, Roberts MK, Moodliar R, Engstrom A, Wang J, Bulger E, Whiteside L, Nehra D, Palinkas LA, Moloney K, Maier R. Stepped Collaborative Care Targeting Posttraumatic Stress Disorder Symptoms and Comorbidity for US Trauma Care Systems: A Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):430-474. doi: 10.1001/jamasurg.2021.0131.

  PMID: 33688908 DERIVED

• Zatzick DF, Russo J, Darnell D, Chambers DA, Palinkas L, Van Eaton E, Wang J, Ingraham LM, Guiney R, Heagerty P, Comstock B, Whiteside LK, Jurkovich G. An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity. Implement Sci. 2016 Apr 30;11:58. doi: 10.1186/s13012-016-0424-4.

  PMID: 27130272 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Cognitive Dysfunction; Pain; Wounds and Injuries; Brain Injuries; Chronic Disease

Interventions

Motivational Interviewing; Fluoxetine; Fluvoxamine; Paroxetine; Sertraline; Citalopram; Venlafaxine Hydrochloride; Duloxetine Hydrochloride; Mirtazapine; Diphenhydramine; Trazodone; Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Suicide; Self-Injurious Behavior; Cognition Disorders; Neurocognitive Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Propylamines; Amines; Organic Chemicals; Oximes; Hydroxylamines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Thiophenes; Sulfur Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Benzhydryl Compounds; Benzene Derivatives; Piperazines; Pyridones; Pyridines; Quinazolines

Results Point of Contact

• Title: Douglas Zatzick
• Organization: University of Washington School of Medicine

dzatzick@uw.edu

206-744-6701

Study Officials

• Douglas Zatzick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: January 14, 2016
• Study Start: October 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-07

Locations

US (24)