A Comparative Effectiveness Trial of Optimal Patient-Centered Care

Study Overview
=================
Brief 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?

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

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

Intervention / Treatment
-----------------
* Behavioral: Stepped Care Management


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient-centered care transition intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced Usual Care - Nurse Notification of Patient Concerns<br>Randomized and will be blindly assessed. | |
| Experimental: Patient-centered care transition<br>Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Randomized and will be blindly assessed. | Behavioral: Stepped Care Management<br>* Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.<br>* Other names: Intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |