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

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University of Washington

Status

Completed

Conditions

Depression and Suicide Ideation
Post Traumatic Stress Disorder
Post Traumatic Concerns
Alcohol and Drug Use

Treatments

Behavioral: Stepped Care Management

Study type

Interventional

Funder types

Other

Identifiers

NCT02274688
IH-1304-6319 (Other Grant/Funding Number)
46615-EJ

Details and patient eligibility

About

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?"

Enrollment

171 patients

Sex

All

Ages

14+ years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

171 participants in 2 patient groups

Enhanced Usual Care - Nurse Notification of Patient Concerns
No Intervention group
Description:
Randomized and will be blindly assessed.
Patient-centered care transition
Experimental group
Description:
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Randomized and will be blindly assessed.
Treatment:
Behavioral: Stepped Care Management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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