NCT01907893

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Orthopedic Trauma

Interventions

Type	Name	Description
BEHAVIORAL	Trauma Collaborative Care Plus Treatment as Usual

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-12-01
• Completion: 2017-03-01
• First posted: 2013-07-25
• Last updated: 2017-04-18

Locations

13 sites across 1 country: United States