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A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems (TSOS 8)

Primary Purpose

PTSD, Physical Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepped Collaborative Care
American College of Surgeons (ACS) Required Screening and Referral (Usual Care)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Physical Injury, Emergency Department Utilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Injured patients ≥18 years of age Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) . Speak English and/or Spanish Exclusion Criteria: Age <18 Not admitted for a traumatic injury Speak a language other than English and/or Spanish Acutely suicidal/admitted for a suicide attempt Cognitively impaired Incarcerated Acutely psychotic Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada Less than 2 pieces of contact information Prior history of violence, such that study staff may not be safe Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition Most recent COVID-19 test positive

Sites / Locations

  • Harborview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped Collaborative Care (Intervention)

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

Arm Description

Patients in the intervention condition will receive a stepped collaborative care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements targeting posttraumatic stress disorder (PTSD) and related comorbidity.

Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral.

Outcomes

Primary Outcome Measures

Posttraumatic Stress Disorder (PTSD) symptoms change over time
The investigators will use the DSM-5 PTSD Checklist (PCL-5) and DSM-IV PTSD Checklist (PCL-IV). The scoring of the PCL-5 scale ranges from a minimum of 0 to a maximum of 80, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Emergency department utilization change over time
Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.

Secondary Outcome Measures

Alcohol use change over time
The investigators will use the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure. The 3-item scale score ranges from 0-12, with higher values indicating a worse outcome.
Mental and physical functioning change over time
The Medical Outcomes Study Short Form healthy survey (SF-12) will be used as a continuous measure. The 12-item scale score ranges from 0-100, with higher scores representing a better outcome. The two summary measures, Physical Component Summary (PCS) and Mental Component Summary (MCS), will be scored.
Depression symptoms change over time
The Patient Health Questionnaire 9-item Depression Scale (PHQ-9) will be used to assess symptoms of depression. The scoring of the scale ranges from 0-27, with higher scores indicating a worse outcome. The scale can also be dichotomized to indicate depressive symptom cutoffs and DSM depressive disorder criteria.
Suicide risk assessment change over time
The Columbia Suicide Severity Rating Scale (CSSRS) is a 6-item questionnaire to assess risk of suicide. The scoring of the scale ranges from 2-25, with higher scores indicating a worse outcome.
Substance use change over time
Single items self report that assesses opioid use, amphetamines, cocaine and marijuana. Single item self-report are categorically rated from no use to use four or more times a week.

Full Information

First Posted
November 17, 2022
Last Updated
January 10, 2023
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05632770
Brief Title
A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems
Acronym
TSOS 8
Official Title
A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.
Detailed Description
Life-threatening traumatic exposures requiring presentation to acute care medical settings are endemic in the US in the era of the COVID-19 pandemic, firearm proliferation, and extreme weather events, and constitute both a substantial source of individual suffering and a significant public health burden. Each year in the US, over 30 million individuals present to acute care medical settings after injury, and approximately 2.5 million individuals are so severely injured that they require inpatient hospital admissions. The overarching goal of the Trauma Survivors Outcomes and Support (TSOS) investigation is to advance the sustainable delivery of high quality trauma center mental health screening, intervention and referral procedures for diverse injury survivors. Over the past two decades, the TSOS study team that includes research scientists, trauma surgical policymakers, patients, and frontline clinicians has established a track record of using evidence derived from NIH pragmatic trials to directly target American College of Surgeons Committee on Trauma (College) regulatory policy. The TSOS investigation will refine and test optimal stepped care intervention strategies for diverse injury survivors presenting to acute care medical settings with PTSD and associated comorbidity. This single trauma center site pragmatic trial investigation will individually randomize 424 patients (212 intervention and 212 control) to a brief stepped care intervention versus College required screening and referral control conditions. The stepped care intervention consists of proactive care management, as well as medications and psychotherapy elements targeting PTSD and comorbidity. Blinded follow-up interviews at 1-, 3-, 6-, and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The emergency department health information exchange will be used to capture population-level automated emergency department/inpatient utilization data for the intent-to-treat sample. The investigation aims to test the primary hypotheses that intervention patients will demonstrate significant reductions in PTSD symptoms and emergency department/inpatient utilization when compared to control patients. The investigation will also explore mediators and moderators of intervention treatment effects that directly address actionable national trauma center quality improvements. A mixed method Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) implementation process assessment will facilitate the integration of study results into national College policy requirements, guidelines, and verification criteria. A national trauma center survey will elucidate the progression of PTSD and comorbidity screening, intervention and referral for all US level I and II trauma centers. An end-of-study College policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high quality acute care medical mental health services for diverse patient populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Physical Injury
Keywords
PTSD, Physical Injury, Emergency Department Utilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stepped Collaborative Care (Intervention)
Arm Type
Experimental
Arm Description
Patients in the intervention condition will receive a stepped collaborative care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and psychotherapy elements targeting posttraumatic stress disorder (PTSD) and related comorbidity.
Arm Title
American College of Surgeons (ACS) Required Screening and Referral (Usual Care)
Arm Type
Active Comparator
Arm Description
Patients in the control condition will receive usual trauma center care with American College of Surgeons (ACS) required psychosocial screening and referral.
Intervention Type
Behavioral
Intervention Name(s)
Stepped Collaborative Care
Intervention Description
Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.
Intervention Type
Behavioral
Intervention Name(s)
American College of Surgeons (ACS) Required Screening and Referral (Usual Care)
Intervention Description
The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder (PTSD) symptoms change over time
Description
The investigators will use the DSM-5 PTSD Checklist (PCL-5) and DSM-IV PTSD Checklist (PCL-IV). The scoring of the PCL-5 scale ranges from a minimum of 0 to a maximum of 80, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Time Frame
Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Title
Emergency department utilization change over time
Description
Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.
Time Frame
Baseline injury admission to 12-months post-injury follow-up
Secondary Outcome Measure Information:
Title
Alcohol use change over time
Description
The investigators will use the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure. The 3-item scale score ranges from 0-12, with higher values indicating a worse outcome.
Time Frame
Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Title
Mental and physical functioning change over time
Description
The Medical Outcomes Study Short Form healthy survey (SF-12) will be used as a continuous measure. The 12-item scale score ranges from 0-100, with higher scores representing a better outcome. The two summary measures, Physical Component Summary (PCS) and Mental Component Summary (MCS), will be scored.
Time Frame
Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Title
Depression symptoms change over time
Description
The Patient Health Questionnaire 9-item Depression Scale (PHQ-9) will be used to assess symptoms of depression. The scoring of the scale ranges from 0-27, with higher scores indicating a worse outcome. The scale can also be dichotomized to indicate depressive symptom cutoffs and DSM depressive disorder criteria.
Time Frame
Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Title
Suicide risk assessment change over time
Description
The Columbia Suicide Severity Rating Scale (CSSRS) is a 6-item questionnaire to assess risk of suicide. The scoring of the scale ranges from 2-25, with higher scores indicating a worse outcome.
Time Frame
Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up
Title
Substance use change over time
Description
Single items self report that assesses opioid use, amphetamines, cocaine and marijuana. Single item self-report are categorically rated from no use to use four or more times a week.
Time Frame
Change in symptoms at baseline injury admission and 1-, 3-, 6-, and 12-months post-injury follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Injured patients ≥18 years of age Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) . Speak English and/or Spanish Exclusion Criteria: Age <18 Not admitted for a traumatic injury Speak a language other than English and/or Spanish Acutely suicidal/admitted for a suicide attempt Cognitively impaired Incarcerated Acutely psychotic Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada Less than 2 pieces of contact information Prior history of violence, such that study staff may not be safe Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition Most recent COVID-19 test positive
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas Zatzick, MD
Phone
206-744-6701
Email
dzatzick@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tanya Knutsen, MSW
Phone
206-406-1273
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Zatzick, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Zatzick, MD
Phone
206-744-6701
Email
dzatzick@uw.edu
First Name & Middle Initial & Last Name & Degree
Allison Engstrom, MSW
Phone
(206) 406-1273
Email
alliengs@uw.edu
First Name & Middle Initial & Last Name & Degree
Douglas Zatzick, MD

12. IPD Sharing Statement

Learn more about this trial

A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

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