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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01907893
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : April 18, 2017
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

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.

Condition or disease Intervention/treatment Phase
Severe Orthopedic Trauma Behavioral: Trauma Collaborative Care Plus Treatment as Usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Trauma Collaborative Care Plus Treatment as Usual
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).
Behavioral: Trauma Collaborative Care Plus Treatment as Usual
Other Name: TSN
No Intervention: Treatment as Usual
Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers.

Primary Outcome Measures :
  1. Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD). [ Time Frame: 12 months ]
    • Functional Status: the Short Musculoskeletal Functional Assessment (SMFA)
    • Depressive Symptoms : the nine item depression scale of the Patient Health Questionnaire (PHQ-9)
    • Post-Traumatic Stress: the PTSD Checklist, civilian version (PCL)

Secondary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: 6 weeks, 6 and 12 months ]
    • Veterans RAND 12 Item Health Survey (VR-12) and its utility based derivative, the VR-6D The 6 week assessment collects pre-injury Health related Quality of life

  2. Return to Usual Activity [ Time Frame: 6 weeks; 6 and 12 months ]
    Standard questions assessing usual major activity The 6 week assessment collects pre injury usual activity

  3. Self Efficacy [ Time Frame: Baseline; 6 weeks; 6 and 12 months ]
    Modified Self-Efficacy Scale

  4. • Use and Satisfaction with TCC Program and its component services (TSN Questions) [ Time Frame: 6 and 12 months ]
    for intervention group only

  5. • Satisfaction with Overall Care [ Time Frame: 6 and 12 months ]
    Short Form Patient Satisfaction Questionnaire (PSQ-18)

  6. Patient productivity in work [ Time Frame: 6 and 12 months ]
    • Work Productivity and Activity Impairment Questionnaire (WPAI)

  7. Referral to TSN activities [ Time Frame: 6 and 12 months ]
    A secondary provider reported outcome(assessed by review of Recovery Plan)

  8. Provider satisfaction [ Time Frame: 6 and 12 months ]
    • Provider satisfaction with care received by their patients in the inpatient and outpatient setting

  9. Provider confidence [ Time Frame: 12 months ]
    • Confidence in managing psychosocial factors related to orthopaedic trauma

  10. Self reported service use [ Time Frame: 6 and 12 months ]
    • Self-reported utilization data on number of inpatient visits, emergency department visits, and unscheduled outpatient surgeries related to study injuries

  11. Intervention program costs [ Time Frame: 12 months ]
    • Costs of the intervention based on costs to implement and sustain program

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01907893

United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80203
United States, Florida
St Josephs Hospital
Tampa, Florida, United States, 33606
Tampa General Hospital
Tampa, Florida, United States, 33608
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland/ R Cowley Adams Shock Trauma Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Spectrum Health/Orthopaedic Institutes of Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Wake Forest Baprtist Medicla Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Metro Health
Cleveland, Ohio, United States, 44109
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Health Science Center - HOUSTON
Houston, Texas, United States, 77030
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Major Extremity Trauma Research Consortium

Responsible Party: Major Extremity Trauma Research Consortium Identifier: NCT01907893     History of Changes
Other Study ID Numbers: METRC - TCCS
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Wounds and Injuries