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| ID | Type | Description | Link |
|---|---|---|---|
| UH2MH106338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. |
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| Usual Care | No Intervention | Only standard care practices will be administered to this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral |
| ||
| Cognitive Behavioral Therapy Elements |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month | 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 and 1-month |
| Change From Baseline Alcohol Use Disorders Identification at 1 Month | 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 and 1-month |
| Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month | 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 and 1-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Status | The investigators will use 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 and 1-month |
| Patient Health Questionnaire Item 9 Suicide Question |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Medical Condition ICD-9 Definition | Moderating Variable | Baseline |
| Traumatic Brain Injury Status ICD-9 Definition | Moderating Variable |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Zatzick, MD | University of Washington | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The intervention aims 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. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Psychotropic Drugs Care Management |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Behavioral |
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| Psychotropic Drugs | Drug |
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| Care Management | Other |
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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 and 1-month |
| Number of Participants Endorsing a Single Item That Assesses Drug Use | Single items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use. | Baseline and 1-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 and 1-month |
| Baseline |
| FG001 | Usual Care | Only standard care practices will be administered to this arm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The intervention aims 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. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Psychotropic Drugs Care Management |
| BG001 | Usual Care | Only standard care practices will be administered to this arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 1-month |
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| Primary | Change From Baseline Alcohol Use Disorders Identification at 1 Month | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 1-month |
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| Primary | Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 1-month |
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| Secondary | Change in Functional Status | The investigators will use 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1-month |
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| Secondary | Patient Health Questionnaire Item 9 Suicide Question | 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. | Posted | Count of Participants | Participants | Baseline and 1-month |
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| Secondary | Number of Participants Endorsing a Single Item That Assesses Drug Use | Single items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use. | Posted | Count of Participants | Participants | Baseline and 1-month |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1-month |
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| Other Pre-specified | Chronic Medical Condition ICD-9 Definition | Moderating Variable | Not Posted | Baseline | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Traumatic Brain Injury Status ICD-9 Definition | Moderating Variable | Not Posted | Baseline | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The intervention aims 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. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Psychotropic Drugs Care Management | 1 | 20 | 1 | 20 | 0 | 20 |
| EG001 | Usual Care | Only standard care practices will be administered to this arm. | 0 | 20 | 0 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical complication unrelated to study participation which resulted in death | Surgical and medical procedures | Non-systematic Assessment | Site 1 recruited a subject on while he was inpatient and completed his baseline interview. Five days later, the subject went in to surgery while still inpatient for repair work on his ankle. The subject died while in surgery. |
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During the pilot study roll-out it was noted that rather than characterizing trauma center providers as staff versus care managers, that a better characterization was to split staff across two trauma centers; this update was made on 2/6/19.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Zatzick, MD | University of Washington Harborview Medical Center | (206) 744-6701 | dzatzick@uw.edu |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D019973 | Alcohol-Related Disorders |
| D059020 | Suicidal Ideation |
| D019966 | Substance-Related Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D011619 | Psychotropic Drugs |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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