Status:
COMPLETED
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Lead Sponsor:
Major Extremity Trauma Research Consortium
Conditions:
Severe Orthopedic Trauma
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ort...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT01907893
Start Date
July 1 2013
End Date
March 1 2017
Last Update
April 18 2017
Active Locations (13)
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1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80203
2
St Josephs Hospital
Tampa, Florida, United States, 33606
3
Tampa General Hospital
Tampa, Florida, United States, 33608
4
Methodist Hospital
Indianapolis, Indiana, United States, 46202