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

Primary Purpose

Post Traumatic Concerns, Post Traumatic Stress Disorder, Depression and Suicide Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepped Care Management
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post Traumatic Concerns

Eligibility Criteria

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

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.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Enhanced Usual Care - Nurse Notification of Patient Concerns

Patient-centered care transition

Arm Description

Randomized and will be blindly assessed.

Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Randomized and will be blindly assessed.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Number of Patients Carrying a Weapon
The investigation used a single yes/no item to assess whether the patient was carrying a weapon.
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
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.

Full Information

First Posted
December 17, 2013
Last Updated
November 17, 2017
Sponsor
University of Washington
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02274688
Brief Title
A Comparative Effectiveness Trial of Optimal Patient-Centered Care
Acronym
TSOS 5
Official Title
A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Concerns, Post Traumatic Stress Disorder, Depression and Suicide Ideation, Alcohol and Drug Use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient-centered care transition intervention
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care - Nurse Notification of Patient Concerns
Arm Type
No Intervention
Arm Description
Randomized and will be blindly assessed.
Arm Title
Patient-centered care transition
Arm Type
Experimental
Arm Description
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Randomized and will be blindly assessed.
Intervention Type
Behavioral
Intervention Name(s)
Stepped Care Management
Other Intervention Name(s)
Intervention
Intervention Description
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Primary Outcome Measure Information:
Title
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
Description
The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Title
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
Description
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.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Title
Change in Depression Symptoms Over the Course of the Six Months After Injury
Description
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.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary Outcome Measure Information:
Title
Alcohol Use Problems
Description
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.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Title
Functional Status
Description
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.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Title
Number of Participants With Suicidal Ideation
Description
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.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Title
Number of Patients Carrying a Weapon
Description
The investigation used a single yes/no item to assess whether the patient was carrying a weapon.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.
Title
Number of Participants With One or More Emergency Department Visits Over Time
Description
The investigators used population level data on emergency department health service use for the intent-to-treat sample
Time Frame
The investigators assessed emergency department service use over the course of the study.
Title
Drug Use Problems
Description
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.
Time Frame
The investigators assessed at baseline, 1-, 3-, and 6-month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33553651
Citation
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.
Results Reference
derived
PubMed Identifier
29533154
Citation
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.
Results Reference
derived

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A Comparative Effectiveness Trial of Optimal Patient-Centered Care

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