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A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity (TSOS6)

Primary Purpose

Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Care Management
Fluoxetine
Fluvoxamine
Paroxetine
Sertraline
Citalopram
Venlafaxine
Duloxetine
Mirtazapine
Diphenhydramine
Trazodone
Prazosin
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Honor Health
  • Cedars Sinai
  • U.C. Davis
  • Santa Clara Valley Medical Center
  • U.C.L.A. Harbor
  • Hartford Hospital
  • Georgia Regents
  • Eskenazi Health
  • University of Iowa
  • University of Kentucky
  • Louisiana State University
  • Regions Hospital
  • Jacobi Medical Center
  • University of Rochester
  • Wake Forest
  • University of Cincinnati
  • Ohio State University
  • Baylor Health Care System
  • UT Southwestern Medical Center
  • University of Texas Medical Branch at Galveston
  • The University of Utah
  • The University of Vermont
  • Inova Trauma Center
  • The University of Wisconsin Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Number of Participants With Suicidal Ideation
Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.
Number of Participants Endorsing a Single Item That Assesses Opioid Use
Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.
Cognitive Impairment Scale
The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.
Brief Pain Inventory
A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.
SF-36 Quality of Life
The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.
TSOS Patient Satisfaction: Overall Health Care
Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Number of Participants Endorsing a Single Item That Assesses Stimulant Use
Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.
Number of Participants Endorsing a Single Item That Assesses Marijuana Use
Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.
TSOS Patient Satisfaction: Mental Health Care
Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

Full Information

First Posted
July 27, 2015
Last Updated
July 1, 2021
Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02655354
Brief Title
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
Acronym
TSOS6
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
635 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy Elements
Intervention Type
Behavioral
Intervention Name(s)
Care Management
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Description
Anti-depressant
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
Sleep medication
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
Sleep medication
Intervention Type
Drug
Intervention Name(s)
Prazosin
Intervention Description
Sleep medication
Primary Outcome Measure Information:
Title
Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury
Description
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.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury
Description
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.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury
Description
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.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury
Description
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.
Time Frame
Baseline, 3-month, 6-month, 12-month
Secondary Outcome Measure Information:
Title
Number of Participants With Suicidal Ideation
Description
Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Number of Participants Endorsing a Single Item That Assesses Opioid Use
Description
Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Cognitive Impairment Scale
Description
The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Brief Pain Inventory
Description
A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
SF-36 Quality of Life
Description
The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
TSOS Patient Satisfaction: Overall Health Care
Description
Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Number of Participants Endorsing a Single Item That Assesses Stimulant Use
Description
Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
Number of Participants Endorsing a Single Item That Assesses Marijuana Use
Description
Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.
Time Frame
Baseline, 3-month, 6-month, 12-month
Title
TSOS Patient Satisfaction: Mental Health Care
Description
Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time Frame
Baseline, 3 Month, 6 Month, 12 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Zatzick, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Cedars Sinai
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
U.C. Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
U.C.L.A. Harbor
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Georgia Regents
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Baylor Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
The University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Inova Trauma Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
The University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35979039
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.
Results Reference
derived
PubMed Identifier
34932440
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.
Results Reference
derived
PubMed Identifier
34225296
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.
Results Reference
derived
PubMed Identifier
33688908
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. Erratum In: JAMA Surg. 2021 Dec 8;:
Results Reference
derived
PubMed Identifier
27130272
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.
Results Reference
derived

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

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