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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trauma
- Sponsor
- Peking University People's Hospital
- Enrollment
- 3200
- Primary Endpoint
- the mortality of patients with severe trauma
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Feifei Jin
Research assistant
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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. -
Outcomes
Primary Outcomes
the mortality of patients with severe trauma
Time Frame: 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.