PTSD Clinical Trial
— TSOS 7 PeerOfficial title:
A Comparative Effectiveness Trial of an Information Technology Enhanced Peer-Integrated Collaborative Care Intervention for US Trauma Care Systems
Verified date | November 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.
Status | Active, not recruiting |
Enrollment | 450 |
Est. completion date | May 11, 2024 |
Est. primary completion date | July 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Inpatient/emergency admission for intentional and/or unintentional injury - Score of =35 on the PTSD checklist - Endorsement of = 1 severe posttraumatic concern Exclusion Criteria: - Patients who required immediate psychiatric intervention - Patients who are not Washington or Oregon State residents - Patients who are currently incarcerated - Patients not speaking Spanish or English |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Harborview Level I Trauma Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Emergency Department Utilization | Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome. | Baseline injury admission to 12-months post-injury follow-up | |
Primary | Change in Posttraumatic Concern Severity | The severity of patient described post-injury concerns as rated by patients on a 1 through 5 scale; 1 being not at all concerning and 5 being extremely concerning. Higher scores are indicative of a worse outcome. The concern outcome can either be represented as a mean severity score or as a percentage of patients with one or more severe concerns. | Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up | |
Primary | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minumum 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 injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up | |
Primary | 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 injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up |
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