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

Study Overview
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Brief Summary
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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
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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.

Conditions
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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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br> <br> Behavioral: Cognitive Behavioral Therapy Elements<br> <br> Behavioral: Care Management<br> <br> Drug: Fluoxetine<br>* Anti-depressant<br>Drug: Fluvoxamine<br>* Anti-depressant<br>Drug: Paroxetine<br>* Anti-depressant<br>Drug: Sertraline<br>* Anti-depressant<br>Drug: Citalopram<br>* Anti-depressant<br>Drug: Venlafaxine<br>* Anti-depressant<br>Drug: Duloxetine<br>* Anti-depressant<br>Drug: Mirtazapine<br>* Anti-depressant<br>Drug: Diphenhydramine<br>* Sleep medication<br>Drug: Trazodone<br>* Sleep medication<br>Drug: Prazosin<br>* Sleep medication<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |