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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
What is being tested?
Stepped Care Management
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

Other trials in United States

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?"

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 groups in NCT02274688
Study groupRoleWhat they receive
Enhanced Usual Care - Nurse Notification of Patient ConcernsNo interventionRandomized and will be blindly assessed.
Patient-centered care transitionExperimentalCase 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.

  1. 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.

  2. 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.

  3. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  1. First posted24 Oct 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2016
  4. Study completion31 Dec 2016

Resources

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)
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
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 37747970
  • Whiteside 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 33553651
  • Zatzick 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

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