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

Study Overview

• Status: Completed
• Conditions: Severe Orthopedic Trauma
• Intervention / Treatment: Behavioral: Trauma Collaborative Care Plus Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD).	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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	• 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	6 weeks, 6 and 12 months
Return to Usual Activity	Standard questions assessing usual major activity The 6 week assessment collects pre injury usual activity	6 weeks; 6 and 12 months
Self Efficacy	Modified Self-Efficacy Scale	Baseline; 6 weeks; 6 and 12 months
• Use and Satisfaction with TCC Program and its component services (TSN Questions)	for intervention group only	6 and 12 months
• Satisfaction with Overall Care	Short Form Patient Satisfaction Questionnaire (PSQ-18)	6 and 12 months
Patient productivity in work	• Work Productivity and Activity Impairment Questionnaire (WPAI)	6 and 12 months
Referral to TSN activities	A secondary provider reported outcome(assessed by review of Recovery Plan)	6 and 12 months
Provider satisfaction	• Provider satisfaction with care received by their patients in the inpatient and outpatient setting	6 and 12 months
Provider confidence	• Confidence in managing psychosocial factors related to orthopaedic trauma	12 months
Self reported service use	• Self-reported utilization data on number of inpatient visits, emergency department visits, and unscheduled outpatient surgeries related to study injuries	6 and 12 months
Intervention program costs	• Costs of the intervention based on costs to implement and sustain program	12 months

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 15, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: METRC - TCCS