Overview

This trial is active, not recruiting.

Conditions post traumatic concerns, post traumatic stress disorder, depression and suicide ideation, alcohol and drug use
Treatment stepped care management
Sponsor University of Washington
Collaborator National Institute of Mental Health (NIMH)
Start date March 2014
End date September 2016
Trial size 120 participants
Trial identifier NCT02274688, IH-1304-6319, K24MH086814-01A1

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?"

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(No Intervention)
Randomized and will be blindly assessed.
(Experimental)
Case management, information technology/mHealth innovations, psychopharmacology, and psychotherapy.
stepped care management Intervention
Case management, information technology, psychopharmacology, and psychotherapy.

Primary Outcomes

Measure
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Change in Post traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Change in Depression Symptoms Over the Course of the Six Months After Injury
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.

Secondary Outcomes

Measure
Alcohol Use Problems
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Functional Status
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Suicide Ideation
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Gun Violence and Weapon Safety
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Health Service Utilization
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.
Drug Use Problems
time frame: The investigators will assess at baseline, 1-, 3-, and 6-month.

Eligibility Criteria

Male or female participants at least 14 years old.

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 or the 5 item Scale for Suicidal Ideation 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.

Additional Information

Official title A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems
Principal investigator Douglas Zatzick, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Washington.