Trial record 9 of 2086 for:    Open Studies | "Wounds and Injuries"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Major Extremity Trauma Research Consortium
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier:
NCT01907893
First received: July 9, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention
Severe Orthopedic Trauma
Behavioral: Trauma Collaborative Care Plus Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)

Resource links provided by NLM:


Further study details as provided by Major Extremity Trauma Research Consortium:

Primary Outcome Measures:
  • Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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:
  • Health Related Quality of Life [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
    • 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

  • Return to Usual Activity [ Time Frame: 6 weeks; 6 and 12 months ] [ Designated as safety issue: No ]
    Standard questions assessing usual major activity The 6 week assessment collects pre injury usual activity

  • Self Efficacy [ Time Frame: Baseline; 6 weeks; 6 and 12 months ] [ Designated as safety issue: No ]
    Modified Self-Efficacy Scale

  • • Use and Satisfaction with TCC Program and its component services (TSN Questions) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    for intervention group only

  • • Satisfaction with Overall Care [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Short Form Patient Satisfaction Questionnaire (PSQ-18)

  • Patient productivity in work [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    • Work Productivity and Activity Impairment Questionnaire (WPAI)

  • Referral to TSN activities [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    A secondary provider reported outcome(assessed by review of Recovery Plan)

  • Provider satisfaction [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    • Provider satisfaction with care received by their patients in the inpatient and outpatient setting

  • Provider confidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Confidence in managing psychosocial factors related to orthopaedic trauma

  • Self reported service use [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    • Self-reported utilization data on number of inpatient visits, emergency department visits, and unscheduled outpatient surgeries related to study injuries

  • Intervention program costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Costs of the intervention based on costs to implement and sustain program


Estimated Enrollment: 900
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
N/A
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907893

Contacts
Contact: Stephen Wegener, PhD swegener@jhmi.edu

Locations
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80203
Contact: David Hak, MD         
Principal Investigator: David Hak, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33608
Contact: Daniel Chan, MD         
Principal Investigator: Daniel Chan         
United States, Indiana
Orthoindy at St Vincent Recruiting
Indianapolis, Indiana, United States, 42260
Contact: Todd McKinley, MD         
Principal Investigator: Todd McKinley, MD         
United States, Maryland
University of Maryland/ R Cowley Adams Shock Trauma Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robert O'Toole, MD         
Principal Investigator: Robert O'Toole, MD         
United States, Michigan
Spectrum Health/Orthopaedic Institutes of Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Clifford Jones, MD         
Principal Investigator: Clifford Jones, MD         
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Andrew Schmidt, MD         
Principal Investigator: Andrew Schmidt, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Michael Bosse, MD         
Principal Investigator: Michael Bosse, MD         
Wake Forest Baprtist Medicla Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Eben Carroll, MD         
Principal Investigator: Eben Carroll, MD         
United States, Ohio
Metro Health Recruiting
Cleveland, Ohio, United States, 44109
Contact: Heather Vallier, MD         
Principal Investigator: Heather Vallier, MD         
United States, Tennessee
Vanderbilt Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kristin Archer         
Principal Investigator: Kristin Archer, PhD         
United States, Texas
University of Texas Health Science Cneter - HOUSTON Recruiting
Houston, Texas, United States, 77030
Contact: Milan Sen, MD         
Principal Investigator: Milan Sen, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Robert Hymes, MD         
Principal Investigator: Robert Hymes, MD         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
  More Information

No publications provided

Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT01907893     History of Changes
Other Study ID Numbers: METRC - TCCS
Study First Received: July 9, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2014