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A Comparative Effectiveness Trial of Optimal Patient-Centered Care (TSOS 5)

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ClinicalTrials.gov Identifier: NCT02274688
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : July 24, 2017
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington

Brief 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. 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?"

Condition or disease Intervention/treatment Phase
Post Traumatic Concerns Post Traumatic Stress Disorder Depression and Suicide Ideation Alcohol and Drug Use Behavioral: Stepped Care Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient-centered care transition intervention
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems
Study Start Date : March 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
No Intervention: Enhanced Usual Care - Nurse Notification of Patient Concerns
Randomized and will be blindly assessed.
Experimental: Patient-centered care transition

Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.

Randomized and will be blindly assessed.

Behavioral: Stepped Care Management
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Other Name: Intervention




Primary Outcome Measures :
  1. Change in Post Traumatic Concerns Over the Course of the Six Months After Injury [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.

  2. Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    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.

  3. Change in Depression Symptoms Over the Course of the Six Months After Injury [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    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.


Secondary Outcome Measures :
  1. Alcohol Use Problems [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    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.

  2. Functional Status [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    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.

  3. Number of Participants With Suicidal Ideation [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    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.

  4. Number of Patients Carrying a Weapon [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    The investigation used a single yes/no item to assess whether the patient was carrying a weapon.

  5. Number of Participants With One or More Emergency Department Visits Over Time [ Time Frame: The investigators assessed emergency department service use over the course of the study. ]
    The investigators used population level data on emergency department health service use for the intent-to-treat sample

  6. Drug Use Problems [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274688


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Douglas Zatzick, MD University of Washington
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02274688    
Other Study ID Numbers: 46615-EJ
IH-1304-6319 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: October 24, 2014    Key Record Dates
Results First Posted: July 24, 2017
Last Update Posted: November 21, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Suicide
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders
Self-Injurious Behavior