A Comparative Effectiveness Trial of Optimal Patient-Centered Care

Post Traumatic Stress Disorder Clinical Trial

— TSOS 5  

Official title:

A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274688
• Other study ID #: 46615-EJ
• Secondary ID: IH-1304-6319
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: November 17, 2017
• Start date: March 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 31, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol and Drug Use
• Depression and Suicide Ideation
• Post Traumatic Concerns
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Suicide

Intervention

Behavioral:
• Stepped Care Management
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post Traumatic Concerns Over the Course of the Six Months After Injury	The primary outcome is the endorsement of =1 severe posttraumatic concerns.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Primary	Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Primary	Change in Depression Symptoms Over the Course of the Six Months After Injury	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary	Alcohol Use Problems	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary	Functional Status	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary	Number of Participants With Suicidal Ideation	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary	Number of Patients Carrying a Weapon	The investigation used a single yes/no item to assess whether the patient was carrying a weapon.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Secondary	Number of Participants With One or More Emergency Department Visits Over Time	The investigators used population level data on emergency department health service use for the intent-to-treat sample	The investigators assessed emergency department service use over the course of the study.
Secondary	Drug Use Problems	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.