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



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:12/24/2016
Start Date:July 2013
End Date:March 2017

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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.


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).
We found this trial at
13
sites
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Grand Rapids, MI
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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Tampa, Florida 33607
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Tampa, FL
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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Baltimore, MD
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Cleveland, Ohio
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Cleveland, OH
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Denver, Colorado 80204
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Denver, CO
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Minneapolis, Minnesota 55414
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Minneapolis, MN
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Nashville, Tennessee 37212
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Nashville, TN
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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