Clinical trial NCT02655354: A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-01-14
Enrollment: 635
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: 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.

Detailed description: Primary Aims and Hypotheses

The primary aim of the UH3 period is to conduct a pragmatic randomized effectiveness trial of a collaborative care intervention targeting PTSD and comorbid conditions after acute care injury hospitalization. The investigation aims to determine if injured patients receiving the collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared to control patients receiving care as usual. The study also aims to determine if the intervention patients when compared to control patients will demonstrate significant reductions in depressive symptoms, suicidal ideation, and alcohol use problems, and improvements in physical function. The primary hypothesis is that the intervention group when compared to the control group will demonstrate significant reductions in PTSD symptoms over the course of the year after injury. Secondary hypotheses are that intervention patients when compared to control patients will demonstrate, significant reductions in depressive symptoms, significant reductions in alcohol use problems, and improved post-injury physical function.

A Priori Secondary Analyses

The study team hypothesizes that a subgroup of patients will have persistent PTSD symptoms that will not remit over the longitudinal course of the investigation, regardless of randomization to intervention or control group conditions. The study team also anticipates that readily identifiable baseline clinical, injury and demographic characteristics will be associated with persistent PTSD symptoms over time (e.g., higher PTSD symptom levels, greater pre-injury trauma exposure, intentional injury including firearm related injury mechanisms and other characteristics such as unemployment, as well as other baseline factors). Derived from previous randomized clinical trials, a cumulative burden index has been developed from these baseline characteristics and will be adapted for the current investigation. The study team proposes a series of secondary analyses that adjust for and stratify by baseline characteristics that put patients at risk for persistent symptoms. It is hypothesized that these secondary analyses will identify a subgroup of intervention patients who are not at risk for persistent symptoms and who will demonstrate clinically and statistically significant treatment responses when compared to patients with similar baseline characteristics in the control condition. The study team also hypothesizes that the treatment effects will be greatest at the 1-6 month post-injury time points that are temporally correlated with the period of active intervention.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury
timeFrame: Baseline, 3-month, 6-month, 12-month
Secondary outcomes:
measure: Number of Participants With Suicidal Ideation
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Number of Participants Endorsing a Single Item That Assesses Opioid Use
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Cognitive Impairment Scale
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Brief Pain Inventory
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: SF-36 Quality of Life
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: TSOS Patient Satisfaction: Overall Health Care
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Number of Participants Endorsing a Single Item That Assesses Stimulant Use
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: Number of Participants Endorsing a Single Item That Assesses Marijuana Use
timeFrame: Baseline, 3-month, 6-month, 12-month
measure: TSOS Patient Satisfaction: Mental Health Care
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Beverly Hills
country: United States
facility: Cedars Sinai
state: California
city: Sacramento
country: United States
facility: U.C. Davis
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Torrance
country: United States
facility: U.C.L.A. Harbor
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Augusta
country: United States
facility: Georgia Regents
state: Georgia
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dallas
country: United States
facility: Baylor Health Care System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Burlington
country: United States
facility: The University of Vermont
state: Vermont
city: Falls Church
country: United States
facility: Inova Trauma Center
state: Virginia
city: Madison
country: United States
facility: The University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Washington
name: Douglas Zatzick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.