Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)

Study Overview
=================
Brief Summary
-----------------
The study uses a multi-site, cluster design to determine the effectiveness of an intervention based on a Trauma Collaborative Care (TCC) model in improving patient outcomes for persons with severe orthopedic trauma and enhancing both patient and provider satisfaction with overall care. The study will also determine the cost and cost-effectiveness of the intervention. Primary Hypothesis: Compared to standard treatment alone, access to the TCC Program plus standard treatment will result in lower rates of the composite outcome (i.e. positive for poor function, depression, and/or PTSD). Secondary Hypotheses: Compared to standard treatment alone, access to the TCC Program plus standard treatment will result in lower levels of pain and higher rates of return to usual major activity and higher levels of health related quality of life. In addition, both primary and secondary outcomes will correlate strongly with the intermediate outcome of self-efficacy.

Official Title
-----------------
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)

Conditions
-----------------
Severe Orthopedic Trauma

Intervention / Treatment
-----------------
* Behavioral: Trauma Collaborative Care Plus Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated surgically for one or more orthopaedic injuries with initial admission to the trauma service of the participating hospital Ages 18-60 yrs inclusive Length of Stay (LOS) >=5 days or >= 3 days with planned readmission for additional procedures At least one orthopaedic injury of AIS 3 or greater (determination based on information available at the time of enrollment) resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, high fall). Injuries can include those to the upper or lower extremities, pelvis/acetabulum or spine. Traumatic amputations of the upper or lower extremities (excluding amputations to fingers or toes) Exclusion Criteria: Initial admission to non-trauma service. Peri-prosthetic fractures of the femur, regardless of etiology Patient eligible for the METRC OUTLET Study, i.e. patient with: Gustilo type III distal tibia and/or foot or type III B or C ankle fractures with fracture pattern consistent with one of OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C, 81B2-B3, 82B, and 82C; Open or closed industrial foot crush injuries; Open or closed foot blast injuries. Patient requiring a Legally Authorized Representative (as defined by an inability to answer the Evaluation of Give Consent questions) Patient non-ambulatory due to an associated spinal cord injury Patient non-ambulatory pre-injury Non-English speaking Patient diagnosed with a severe psychosis Patient lives outside the hospital's catchment area and/or follow-up is planned at another medical center Severe problems with maintaining follow-up expected (e.g. patients who are prisoners or homeless at the time of injury or those who are severely intellectually challenged).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma Collaborative Care Plus Treatment as Usual<br>Three components: (1) Services provided through the Trauma Survivors Network (TSN) Program; (2) Provider training to reinforce referral to and use of TSN programs; and (3) Enhancement of collaborative care through the use of a TSN Coordinator (TSN-C). | Behavioral: Trauma Collaborative Care Plus Treatment as Usual<br> <br> * Other names: TSN;|
| No Intervention: Treatment as Usual<br>Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD). | Functional Status: the Short Musculoskeletal Functional Assessment (SMFA) Depressive Symptoms : the nine item depression scale of the Patient Health Questionnaire (PHQ-9) Post-Traumatic Stress: the PTSD Checklist, civilian version (PCL) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | • Veterans RAND 12 Item Health Survey (VR-12) and its utility based derivative, the VR-6D The 6 week assessment collects pre-injury Health related Quality of life | 6 weeks, 6 and 12 months | 
| Return to Usual Activity | Standard questions assessing usual major activity The 6 week assessment collects pre injury usual activity | 6 weeks; 6 and 12 months | 
| Self Efficacy | Modified Self-Efficacy Scale | Baseline; 6 weeks; 6 and 12 months | 
| • Use and Satisfaction with TCC Program and its component services (TSN Questions) | for intervention group only | 6 and 12 months | 
| • Satisfaction with Overall Care | Short Form Patient Satisfaction Questionnaire (PSQ-18) | 6 and 12 months | 
| Patient productivity in work | • Work Productivity and Activity Impairment Questionnaire (WPAI) | 6 and 12 months | 
| Referral to TSN activities | A secondary provider reported outcome(assessed by review of Recovery Plan) | 6 and 12 months | 
| Provider satisfaction | • Provider satisfaction with care received by their patients in the inpatient and outpatient setting | 6 and 12 months | 
| Provider confidence | • Confidence in managing psychosocial factors related to orthopaedic trauma | 12 months | 
| Self reported service use | • Self-reported utilization data on number of inpatient visits, emergency department visits, and unscheduled outpatient surgeries related to study injuries | 6 and 12 months | 
| Intervention program costs | • Costs of the intervention based on costs to implement and sustain program | 12 months |