Severe Orthopedic TraumaTCCSNCT01907893
Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
A study testing Trauma Collaborative Care Plus Treatment as Usual in people with Severe Orthopedic Trauma, run by Major Extremity Trauma Research Consortium at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Orthopedic Trauma
- What is being tested?
- Trauma Collaborative Care Plus Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Maryland/ R Cowley Adams Shock Trauma Center
Baltimore, Maryland, 21201
Carolinas Medical Center
Charlotte, North Carolina, 28204
Metro Health
Cleveland, Ohio, 44109
Denver Health and Hospital Authority
Denver, Colorado, 80203
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Spectrum Health/Orthopaedic Institutes of Michigan
Grand Rapids, Michigan, 49503
University of Texas Health Science Center - HOUSTON
Houston, Texas, 77030
Methodist Hospital
Indianapolis, Indiana, 46202
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Vanderbilt Medical Center
Nashville, Tennessee, 37232
St Josephs Hospital
Tampa, Florida, 33606
Tampa General Hospital
Tampa, Florida, 33608
Wake Forest Baprtist Medicla Center
Winston-Salem, North Carolina, 27157
About this study
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.
- Conditions
- Severe Orthopedic Trauma
- Being tested
- Trauma Collaborative Care Plus Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Collaborative Care Plus Treatment as UsualBehavioural
Also called TSN
| Study group | Role | What they receive |
|---|---|---|
| Trauma Collaborative Care Plus Treatment as Usual | Experimental | 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). Receives: Behavioral: Trauma Collaborative Care Plus Treatment as Usual |
| Treatment as Usual | No intervention | Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (11)
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
Measured: 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
Measured: 6 weeks; 6 and 12 months
Self Efficacy
Modified Self-Efficacy Scale
Measured: Baseline; 6 weeks; 6 and 12 months
• Use and Satisfaction with TCC Program and its component services (TSN Questions)
for intervention group only
Measured: 6 and 12 months
• Satisfaction with Overall Care
Short Form Patient Satisfaction Questionnaire (PSQ-18)
Measured: 6 and 12 months
Patient productivity in work
- Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 6 and 12 months
Referral to TSN activities
A secondary provider reported outcome(assessed by review of Recovery Plan)
Measured: 6 and 12 months
Provider satisfaction
- Provider satisfaction with care received by their patients in the inpatient and outpatient setting
Measured: 6 and 12 months
Provider confidence
- Confidence in managing psychosocial factors related to orthopaedic trauma
Measured: 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
Measured: 6 and 12 months
Intervention program costs
- Costs of the intervention based on costs to implement and sustain program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Orthopedic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907893
- Sponsor's protocol ID
- METRC - TCCS
- Acronym
- TCCS
- Status last verified
- Apr 2017
- First submitted
- 9 Jul 2013
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
- ClinicalTrials.gov ID
- NCT01907893
- Acronym / sponsor ID
- TCCS / METRC - TCCS
- Conditions
- Severe Orthopedic Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Collaborative Care Plus Treatment as Usual | Experimental | Behavioral: Trauma Collaborative Care Plus Treatment as UsualThree 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). |
| Treatment as Usual | No intervention | –Study patients treated at Control Sites will have access to all services typically available to patients treated at these centers. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Collaborative Care Plus Treatment as UsualAlso: TSN | Behavioural | Trauma Collaborative Care Plus Treatment as Usual |
Primary outcome
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)
11 secondary outcomes
Health Related Quality of Life
Time frame: 6 weeks, 6 and 12 months
Return to Usual Activity
Time frame: 6 weeks; 6 and 12 months
Self Efficacy
Time frame: Baseline; 6 weeks; 6 and 12 months
• Use and Satisfaction with TCC Program and its component services (TSN Questions)
Time frame: 6 and 12 months
• Satisfaction with Overall Care
Time frame: 6 and 12 months
Patient productivity in work
Time frame: 6 and 12 months
Referral to TSN activities
Time frame: 6 and 12 months
Provider satisfaction
Time frame: 6 and 12 months
Provider confidence
Time frame: 12 months
Self reported service use
Time frame: 6 and 12 months
Intervention program costs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Collaborative Care Plus Treatment as Usual in people with Severe Orthopedic Trauma, run by Major Extremity Trauma Research Consortium at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.