N/A
N=171
A Comparative Effectiveness Trial of Optimal Patient-Centered Care
Post Traumatic Concerns · Post Traumatic Stress Disorder · Depression and Suicide Ideation · Alcohol and Drug Use
Bottom Line
View on ClinicalTrials.gov: NCT02274688 ↗Enrolled (actual)
171
Serious AEs
1.8%
Results posted
Jul 2017
Primary outcome: Primary: Change in Post Traumatic Concerns Over the Course of the Six Months After Injury — 80; 83; 55; 59 Participants — p==0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stepped Care Management (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Post Traumatic Concerns Over the Course of the Six Months After Injury |
80; 83; 55; 59; 45; 48 | =0.01 sig |
| PRIMARY Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury |
42.9; 42.5; 41.7; 43.7; 40.7; 38.7 | =0.23 |
| PRIMARY Change in Depression Symptoms Over the Course of the Six Months After Injury |
14.8; 14.3; 12.1; 13.2; 11.7; 10.8 | =0.23 |
| SECONDARY Alcohol Use Problems |
3.7; 3.4; 1.1; 0.5; 1.7; 1.1 | =0.55 |
| SECONDARY Functional Status |
48.4; 48.5; 38.3; 37.1; 39.3; 39.8 | =0.32 |
| SECONDARY Number of Participants With Suicidal Ideation |
19; 22; 13; 18; 21; 14 | =0.26 |
| SECONDARY Number of Patients Carrying a Weapon |
7; 12; 4; 3; 7; 5 | =0.22 |
| SECONDARY Number of Participants With One or More Emergency Department Visits Over Time |
41; 44; 26; 14; 27; 18 | =0.08 |
| SECONDARY Drug Use Problems |
2.0; 2.2; 1.4; 1.3; 1.4; 1.3 | 0.36 |
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.
Data sourced from ClinicalTrials.gov (NCT02274688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.