Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma: Protocol for a Prospective, Multicenter, Stepped-wedge Cluster-randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,200
- 主要终点
- the mortality of patients with severe trauma
研究概览
简要总结
Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial.
详细描述
Background: Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.
Methods: This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial. Twenty hospitals are selected based on specific eligibility criteria. After the baseline period, 5 randomization steps with 4 hospitals per step will be conducted. Each hospital will gradually enter intervention period in the randomized order for the implementation of regional trauma care system. The initial 1-month is considered as the intervention transition period, during which hospitals are modified and healthcare workers are trained according to the requirements of the regional trauma care system.
Conclusion: This is the first study assessing the effectiveness of the regional trauma care system on the treatment of patients with severe trauma with the conduction a prospective study in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Age of 18-60 years old, with no restriction on gender;
- •Severe trauma, including trauma patients with ISS score ≥ 16;
- •Time from trauma to admission <24h.
排除标准
- •Patients who complicated with underlying diseases, such as malignant tumor and diabetes mellitus;
- •Patients with important organ dysfunction before trauma;
- •The investigator considers not appropriate for enrollment. -
研究组 & 干预措施
intervention
Study intervention is the establishment of in-hospital trauma treatment centers and the formation of regional trauma care system. Regional trauma care system refers to both the establishment of unified and standardized pre-hospital and in-hospital trauma triage and injury classification warning mechanism and the development of unified trauma treatment process and standard in a main government district (population within 1 million), with secondary general hospitals and above that have strong treatment capability as the trauma treatment centers. Regional trauma care system will strengthen both pre-hospital emergency care and in-hospital emergency treatment while reinforcing the information exchange between in-hospital emergency treatment and specialized treatment.
干预措施: regional trauma care (Other)
usual care
usual care/standard of care no intervention implemented
结局指标
主要结局
the mortality of patients with severe trauma
时间窗: one week
The primary efficacy indicator is the mortality of patients with severe trauma at one week after trauma treatment. Mortality is defined as the percentage of patients with severe trauma who die after trauma treatment to the total number of patients with severe trauma receiving treatment.
次要结局
未报告次要终点
研究者
Feifei Jin
Research assistant
Peking University People's Hospital