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

Major Extremity Trauma Research Consortium

Status: Completed

Conditions: Severe Orthopedic Trauma

Treatments: Behavioral: Trauma Collaborative Care Plus Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT01907893

METRC - TCCS

Details and patient eligibility

About

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.

Enrollment: 900 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Trauma Collaborative Care Plus Treatment as Usual

Experimental group

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).

Treatment:

Behavioral: Trauma Collaborative Care Plus Treatment as Usual

Treatment as Usual

No Intervention group

Description:

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