Overview

This trial is active, not recruiting.

Condition severe orthopedic trauma
Treatment trauma collaborative care plus treatment as usual
Sponsor Major Extremity Trauma Research Consortium
Start date July 2013
End date December 2014
Trial size 900 participants
Trial identifier NCT01907893, METRC - TCCS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
trauma collaborative care plus treatment as usual TSN
(No Intervention)
Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers.

Primary Outcomes

Measure
Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD).
time frame: 12 months

Secondary Outcomes

Measure
Health Related Quality of Life
time frame: 6 weeks, 6 and 12 months
Return to Usual Activity
time frame: 6 weeks; 6 and 12 months
Self Efficacy
time frame: Baseline; 6 weeks; 6 and 12 months
• Use and Satisfaction with TCC Program and its component services (TSN Questions)
time frame: 6 and 12 months
• Satisfaction with Overall Care
time frame: 6 and 12 months
Patient productivity in work
time frame: 6 and 12 months
Referral to TSN activities
time frame: 6 and 12 months
Provider satisfaction
time frame: 6 and 12 months
Provider confidence
time frame: 12 months
Self reported service use
time frame: 6 and 12 months
Intervention program costs
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Patients treated surgically for one or more orthopaedic injuries with initial admission to the trauma service of the participating hospital 2. Ages 18-60 yrs inclusive 3. Length of Stay (LOS) >=5 days or >= 3 days with planned readmission for additional procedures 4. 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. 5. Traumatic amputations of the upper or lower extremities (excluding amputations to fingers or toes) Exclusion Criteria: 1. Initial admission to non-trauma service. 2. Peri-prosthetic fractures of the femur, regardless of etiology 3. Patient eligible for the METRC OUTLET Study, i.e. patient with: 1. 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; 2. Open or closed industrial foot crush injuries; 3. Open or closed foot blast injuries. 4. Patient requiring a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions) 5. Patient non-ambulatory due to an associated spinal cord injury 6. Patient non-ambulatory pre-injury 7. Non-English speaking 8. Patient diagnosed with a severe psychosis 9. Patient lives outside the hospital's catchment area and/or follow-up is planned at another medical center 10. 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).

Additional Information

Official title Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium.