Harborview Medical Center
Seattle, Washington, 98104, United States
NCT Number: NCT02274688
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?"
Looking for future studies?
Notify Me14 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98104, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Other names: Intervention
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.
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.
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.
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.
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.
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.
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.
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
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.
University of Washington
Other
A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems
Acronym: TSOS 5
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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