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Completed

NCT Number: NCT01907893

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health and Hospital Authority, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients treated surgically for one or more orthopaedic injuries with initial admission to the trauma service of the participating hospital
  • Ages 18-60 yrs inclusive
  • Length of Stay (LOS) >=5 days or >= 3 days with planned readmission for additional procedures
  • 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.
  • Traumatic amputations of the upper or lower extremities (excluding amputations to fingers or toes)

Exclusion criteria

  • Initial admission to non-trauma service.
  • Peri-prosthetic fractures of the femur, regardless of etiology
  • Patient eligible for the METRC OUTLET Study, i.e. patient with:
  • 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;
  • Open or closed industrial foot crush injuries;
  • Open or closed foot blast injuries.
  • Patient requiring a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
  • Patient non-ambulatory due to an associated spinal cord injury
  • Patient non-ambulatory pre-injury
  • Non-English speaking
  • Patient diagnosed with a severe psychosis
  • Patient lives outside the hospital's catchment area and/or follow-up is planned at another medical center
  • 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).

Treatment and study plan

Trauma Collaborative Care Plus Treatment as Usual

Behavioral

Other names: TSN

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Major Extremity Trauma Research Consortium

Other

Registry information

Acronym: TCCS

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Jul 25, 2013
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.