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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma Collaborative Care Plus Treatment as Usual | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD). |
| 12 months |
| 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 |
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Inclusion Criteria:
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:
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80203 | United States | ||
| St Josephs Hospital |
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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 |
| Tampa |
| Florida |
| 33606 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33608 | United States |
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Maryland/ R Cowley Adams Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| Spectrum Health/Orthopaedic Institutes of Michigan | Grand Rapids | Michigan | 49503 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Wake Forest Baprtist Medicla Center | Winston-Salem | North Carolina | 27157 | United States |
| Metro Health | Cleveland | Ohio | 44109 | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Health Science Center - HOUSTON | Houston | Texas | 77030 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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