Clinical trial NCT01907893: Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Official title: Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Orthopedic Trauma
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD).
timeFrame: 12 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 weeks, 6 and 12 months
measure: Return to Usual Activity
timeFrame: 6 weeks; 6 and 12 months
measure: Self Efficacy
timeFrame: Baseline; 6 weeks; 6 and 12 months
measure: • Use and Satisfaction with TCC Program and its component services (TSN Questions)
timeFrame: 6 and 12 months
measure: • Satisfaction with Overall Care
timeFrame: 6 and 12 months
measure: Patient productivity in work
timeFrame: 6 and 12 months
measure: Referral to TSN activities
timeFrame: 6 and 12 months
measure: Provider satisfaction
timeFrame: 6 and 12 months
measure: Provider confidence
timeFrame: 12 months
measure: Self reported service use
timeFrame: 6 and 12 months
measure: Intervention program costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Tampa
country: United States
facility: St Josephs Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland/ R Cowley Adams Shock Trauma Center
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health/Orthopaedic Institutes of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baprtist Medicla Center
state: North Carolina
city: Cleveland
country: United States
facility: Metro Health
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center - HOUSTON
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References: