Establishment of Regional Severe Trauma Management System

Study Overview
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Brief Summary
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To evaluate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.

Detailed Description
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This is a national multi-center, cluster-randomized controlled trial. This cluster-randomized controlled trial will be performed, with counties as the randomization units. The included counties will be randomized into an experimental group and a control group. A trauma treatment team will be only established in the experimental group. The in-hospital mortality rate will be compared between the experimental and control groups to investigate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.

Official Title
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Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial

Conditions
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Trauma, Multiple Trauma, Emergencies

Intervention / Treatment
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* Other: trauma treatment team
* Other: Basic experimental settings


Participation Criteria
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Eligibility Criteria
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In this study, three-level subjects (counties, hospitals, and trauma patients) will be included according to the following inclusion and exclusion criteria: inclusion: Inclusion criteria of counties: National counties and county-level administrative regions; Local government and health management department have the desire and requirements to establish a standardized trauma emergency treatment system; More than 500,000 people; With pre-hospital emergency treatment system; Trauma first aid needs: No less than 20 patients with severe trauma (ISS ≥ 16) throughout the county; Inclusion criteria of hospitals: With the most advanced regional treatment resources during the entire period from trauma recovery to rehabilitation for third-grade class A hospitals; With basic trauma treatment resources for second-grade class A hospitals; Trauma doctors are on call 24 hours a day and can participate in the early treatment of patients with trauma; Inclusion criteria of patients: Patients with acute trauma occurring within 48 hours; Patients are transferred to trauma treatment center hospital or trauma treatment non-center hospitals; Patients themselves go to or are transferred by their family members to the trauma treatment center hospital or trauma treatment non-center hospita; Exclusion: Exclusion criteria of counties: ○ All second-grade class A or third-grade class A hospitals in the county cannot establish a trauma treatment team because of various reasons; Exclusion criteria of hospitals: ○ Hospitals can not establish a trauma treatment team because of various reasons; Exclusion criteria of patients: Patients with trauma from regions not included in this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>The trauma treatment team will be established in the experimental group | Other: trauma treatment team<br>* Establishing the trauma management system included a trauma treatment team. The severe trauma treatment team will be composed by the physicians from departments of emergency, orthopedic trauma, urology, cardiothoracic surgery, neurosurgery, general surgery, anesthesiology, and ICU.<br>|
| Active Comparator: control group<br>The trauma treatment team will not be established in this group，just establish the basic experimental settings | Other: Basic experimental settings<br>* Establishing the trauma management system without a trauma treatment team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality rate | the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma. | from hospital admission to discharge, an average of 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate of patients with severe trauma within 30 days after trauma attack | the percentage of patients who die within 30 days after trauma attack in admitted patients with severe trauma | within 30 days after trauma attack | 
| Mortality rate of patients with severe trauma within 30 days after discharge | the percentage of patients who die within 30 days after discharge in admitted patients with severe trauma | within 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe trauma, Multiple trauma, Regional Trauma management system, Trauma management team