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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Severe Orthopedic Trauma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Trauma Collaborative Care Plus Treatment as Usual

Intervention Type BEHAVIORAL

Treatment as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trauma Collaborative Care Plus Treatment as Usual

Intervention Type BEHAVIORAL

Other Intervention Names

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TSN

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No