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

Depression Clinical Trial

— TSOS6  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655354
• Other study ID #: 20150987
• Secondary ID: UH3MH106338
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2019

Study information

• Verified date: July 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Motivational Interviewing

• Cognitive Behavioral Therapy Elements

• Care Management

Drug:
• Fluoxetine
Anti-depressant
• Fluvoxamine
Anti-depressant
• Paroxetine
Anti-depressant
• Sertraline
Anti-depressant
• Citalopram
Anti-depressant
• Venlafaxine
Anti-depressant
• Duloxetine
Anti-depressant
• Mirtazapine
Anti-depressant
• Diphenhydramine
Sleep medication
• Trazodone
Sleep medication
• Prazosin
Sleep medication

Locations

Country	Name	City	State
United States	Georgia Regents	Augusta	Georgia
United States	Cedars Sinai	Beverly Hills	California
United States	Jacobi Medical Center	Bronx	New York
United States	The University of Vermont	Burlington	Vermont
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Baylor Health Care System	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Inova Trauma Center	Falls Church	Virginia
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Eskenazi Health	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Kentucky	Lexington	Kentucky
United States	The University of Wisconsin Madison	Madison	Wisconsin
United States	Louisiana State University	New Orleans	Louisiana
United States	University of Rochester	Rochester	New York
United States	U.C. Davis	Sacramento	California
United States	Regions Hospital	Saint Paul	Minnesota
United States	The University of Utah	Salt Lake City	Utah
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Honor Health	Scottsdale	Arizona
United States	U.C.L.A. Harbor	Torrance	California
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3-month, 6-month, 12-month
Secondary	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.	Baseline, 3 Month, 6 Month, 12 Month