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

Completed · Not applicable

Conditions studied: Severe Orthopedic Trauma

In brief

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.

Key facts

Study ID

NCT01907893

Run by

Major Extremity Trauma Research Consortium

People needed

900

Starts

2013-07-01

Expected to finish

2017-03-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• Denver Health and Hospital Authority — Denver, Colorado, United States
• St Josephs Hospital — Tampa, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland/ R Cowley Adams Shock Trauma Center — Baltimore, Maryland, United States
• Spectrum Health/Orthopaedic Institutes of Michigan — Grand Rapids, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest Baprtist Medicla Center — Winston-Salem, North Carolina, United States
• Metro Health — Cleveland, Ohio, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• University of Texas Health Science Center - HOUSTON — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.