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

Primary Purpose

Severe Orthopedic Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Collaborative Care Plus Treatment as Usual
Sponsored by
Major Extremity Trauma Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Orthopedic Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Denver Health and Hospital Authority
  • St Josephs Hospital
  • Tampa General Hospital
  • Methodist Hospital
  • University of Maryland/ R Cowley Adams Shock Trauma Center
  • Spectrum Health/Orthopaedic Institutes of Michigan
  • Hennepin County Medical Center
  • Carolinas Medical Center
  • Wake Forest Baprtist Medicla Center
  • Metro Health
  • Vanderbilt Medical Center
  • University of Texas Health Science Center - HOUSTON
  • Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trauma Collaborative Care Plus Treatment as Usual

Treatment as Usual

Arm Description

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).

Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2013
Last Updated
April 15, 2017
Sponsor
Major Extremity Trauma Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT01907893
Brief Title
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Acronym
TCCS
Official Title
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Major Extremity Trauma Research Consortium

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Orthopedic Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma Collaborative Care Plus Treatment as Usual
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Collaborative Care Plus Treatment as Usual
Other Intervention Name(s)
TSN
Primary Outcome Measure Information:
Title
Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD).
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
• 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
Time Frame
6 weeks, 6 and 12 months
Title
Return to Usual Activity
Description
Standard questions assessing usual major activity The 6 week assessment collects pre injury usual activity
Time Frame
6 weeks; 6 and 12 months
Title
Self Efficacy
Description
Modified Self-Efficacy Scale
Time Frame
Baseline; 6 weeks; 6 and 12 months
Title
• Use and Satisfaction with TCC Program and its component services (TSN Questions)
Description
for intervention group only
Time Frame
6 and 12 months
Title
• Satisfaction with Overall Care
Description
Short Form Patient Satisfaction Questionnaire (PSQ-18)
Time Frame
6 and 12 months
Title
Patient productivity in work
Description
• Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame
6 and 12 months
Title
Referral to TSN activities
Description
A secondary provider reported outcome(assessed by review of Recovery Plan)
Time Frame
6 and 12 months
Title
Provider satisfaction
Description
• Provider satisfaction with care received by their patients in the inpatient and outpatient setting
Time Frame
6 and 12 months
Title
Provider confidence
Description
• Confidence in managing psychosocial factors related to orthopaedic trauma
Time Frame
12 months
Title
Self reported service use
Description
• Self-reported utilization data on number of inpatient visits, emergency department visits, and unscheduled outpatient surgeries related to study injuries
Time Frame
6 and 12 months
Title
Intervention program costs
Description
• Costs of the intervention based on costs to implement and sustain program
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80203
Country
United States
Facility Name
St Josephs Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33608
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland/ R Cowley Adams Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Spectrum Health/Orthopaedic Institutes of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest Baprtist Medicla Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Metro Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Health Science Center - HOUSTON
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

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

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