Improving Activity and Quality of Life Following Orthopaedic Trauma: The Trauma Collaborative Care Study (TCCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 26
- 主要终点
- Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
结局指标
主要结局
Composite Outcome: A binary composite outcome comprised of patient reported assessments of function, depression and post traumatic stress (PTSD).
时间窗: 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)
次要结局
- Patient productivity in work(6 and 12 months)
- Referral to TSN activities(6 and 12 months)
- Provider satisfaction(6 and 12 months)
- • Satisfaction with Overall Care(6 and 12 months)
- Health Related Quality of Life(6 weeks, 6 and 12 months)
- Return to Usual Activity(6 weeks; 6 and 12 months)
- Self Efficacy(Baseline; 6 weeks; 6 and 12 months)
- • Use and Satisfaction with TCC Program and its component services (TSN Questions)(6 and 12 months)
- Provider confidence(12 months)
- Self reported service use(6 and 12 months)
- Intervention program costs(12 months)