Clinical trial NCT02274688: A Comparative Effectiveness Trial of Optimal Patient-Centered Care
Official title: A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Concerns
Post Traumatic Stress Disorder
Depression and Suicide Ideation
Alcohol and Drug Use
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-24
Enrollment: 171
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-centered care transition intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

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?"


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.

Primary outcomes:
measure: Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Change in Depression Symptoms Over the Course of the Six Months After Injury
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary outcomes:
measure: Alcohol Use Problems
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Functional Status
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Number of Participants With Suicidal Ideation
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Number of Patients Carrying a Weapon
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Number of Participants With One or More Emergency Department Visits Over Time
timeFrame: The investigators assessed emergency department service use over the course of the study.
measure: Drug Use Problems
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Douglas Zatzick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.