Post Traumatic ConcernsTSOS 5NCT02274688
A Comparative Effectiveness Trial of Optimal Patient-Centered Care
A study testing Stepped Care Management in people with Post Traumatic Concerns and Post Traumatic Stress Disorder, run by University of Washington at 1 site in United States.
Trial summary
The nation's trauma care system, which includes trauma center hospitals \& emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Post Traumatic Concerns, Post Traumatic Stress Disorder, Depression and Suicide Ideation
- What is being tested?
- Stepped Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 31 Dec 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Seen in acute care emergency department or trauma center setting for injury
- At least three post traumatic concerns
- AND One of the following PTSD Checklist Score (PCL-C) greater than or equal to 35 Patient Health Questionnaire 9 - greater than or equal to 10 Any endorsement of suicidal ideation on the PhQ-9 Item 9
Who cannot join
- Non-English speaking
- Under 14 years of age
- Incarcerated
- Psychotic behavior
- Suffered head, spinal cord, or other severe injuries that prevent participation in the inpatient ward interview.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems
The nation's trauma care system, which includes trauma center hospitals \& emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical \& mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, \& community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns \& preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers \& policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health \& patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury \& recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials \& standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates \& best practice guidelines for post-traumatic stress disorder \& alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns \& integrates patient concerns \& preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients \& their caregivers, front-line providers \& policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" \& "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health \& health care?"
- Conditions
- Post Traumatic Concerns, Post Traumatic Stress Disorder, Depression and Suicide Ideation, Alcohol and Drug Use
- Being tested
- Stepped Care Management
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Care ManagementBehavioural
Also called Intervention
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | No intervention | Randomized and will be blindly assessed. |
| Patient-centered care transition | Experimental | Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Randomized and will be blindly assessed. Receives: Behavioral: Stepped Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Change in Depression Symptoms Over the Course of the Six Months After Injury
The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary outcomes (6)
Alcohol Use Problems
The investigators used 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. No sub scales were used.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Functional Status
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. No other subscales will be used.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Number of Participants With Suicidal Ideation
The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of > 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Number of Patients Carrying a Weapon
The investigation used a single yes/no item to assess whether the patient was carrying a weapon.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Number of Participants With One or More Emergency Department Visits Over Time
The investigators used population level data on emergency department health service use for the intent-to-treat sample
Measured: The investigators assessed emergency department service use over the course of the study.
Drug Use Problems
The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used.
Measured: The investigators assessed at baseline, 1-, 3-, and 6-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic ConcernsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient-centered care transition intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Douglas Zatzick, University of Washington
- Investigators
- Douglas Zatzick, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274688
- Sponsor's protocol ID
- 46615-EJ
- Other IDs
- IH-1304-6319
- Acronym
- TSOS 5
- Status last verified
- Nov 2017
- First submitted
- 17 Dec 2013
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Prater L, Bulger E, Maier RV, Goldstein E, Thomas P, Russo J, Wang J, Engstrom A, Abu K, Whiteside L, Knutzen T, Iles-Shih M, Heagerty P, Zatzick D. Emergency Department and Inpatient Utilization Reductions and Cost Savings Associated With Trauma Center Mental Health Intervention: Results From a 5-year Longitudinal Randomized Clinical Trial Analysis. Ann Surg. 2024 Jan 1;279(1):17-23. doi: 10.1097/SLA.0000000000006102. Epub 2023 Sep 25.
PubMed 37747970Whiteside LK, Vrablik MC, Russo J, Bulger EM, Nehra D, Moloney K, Zatzick DF. Leveraging a health information exchange to examine the accuracy of self-report emergency department utilization data among hospitalized injury survivors. Trauma Surg Acute Care Open. 2021 Jan 28;6(1):e000550. doi: 10.1136/tsaco-2020-000550. eCollection 2021.
PubMed 33553651Zatzick D, Russo J, Thomas P, Darnell D, Teter H, Ingraham L, Whiteside LK, Wang J, Guiney R, Parker L, Sandgren K, Hedrick MK, Van Eaton EG, Jurkovich G. Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial. Psychiatry. 2018 Summer;81(2):141-157. doi: 10.1080/00332747.2017.1354621. Epub 2018 Mar 13.
PubMed 29533154