Trauma Survivors Outcomes and Support Study IV (TSOS IV)
After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.
Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.
|Posttraumatic Stress Disorder Depression Suicide Traumatic Brain Injury Alcohol Use Drug Use||Behavioral: Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Integrating Information Technology Advancements Into Early PTSD Interventions|
- PTSD ratings [ Time Frame: Up to 6 months after injury ]Assessed using the Posttraumatic Stress Disorder Checklist (PCL-C) and suicide ratings.
- Depression ratings [ Time Frame: Up to 6 months after injury ]Assessed using the Personal Health Questionnaire (PHQ-9)and the Scale for Suicide Ideation (SSI)
- Technology use and acceptability [ Time Frame: Up to 6 months after injury ]Assessed using Personal Technology Survey and Acceptability Measures created for this study.
- Feasibility and Acceptability of Intervention [ Time Frame: Up to 6 months after injury ]Assessed by feasibility and acceptability measures created for this study.
- Substance use [ Time Frame: Up to 6 months after injury ]Assessed using the Alcohol Use Disorders Identification Test (AUDIT) and The Drug Abuse Screening Test (DAST)
- General functioning reports [ Time Frame: Up to 6 months after injury ]Assessed using the SF-12 Health Survey, Sheehan Disability Scale (SDS), and Functional Capacity Index (FCI)
- Increased satisfaction with global care [ Time Frame: Up to 6 months after injury ]Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care(NSCOT)
- Injury relapse [ Time Frame: Up to 5 years after injury ]Assessed using Healthcare Utilization Questions (NSCOT)
- Work, disability, and legal outcomes [ Time Frame: Up to 6 months after injury ]Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: Stepped Care Management||
Behavioral: Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
No Intervention: Usual Care
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625416
|Contact: Douglas Zatzick, M.D.||email@example.com|
|Contact: Collin McFadden, B.A.||firstname.lastname@example.org|
|United States, Washington|
|Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Collin McFadden, B.A. 206-744-1759 email@example.com|
|Principal Investigator: Douglas Zatzick, M.D.|
|Principal Investigator:||Douglas Zatzick, M.D.||University of Washington|