Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma

NCT ID: NCT05799170

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-12-31

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.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

regional trauma care

Intervention Type: OTHER

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. Taking 5 to 6 hospitals with certain trauma treatment capacity as the trauma treatment point, the trauma treatment network is formed relying on the treatment point hospitals within the range of one trauma treatment center.

usual care

usual care/standard of care no intervention implemented

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

regional trauma care

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. Taking 5 to 6 hospitals with certain trauma treatment capacity as the trauma treatment point, the trauma treatment network is formed relying on the treatment point hospitals within the range of one trauma treatment center.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age of 18-60 years old, with no restriction on gender;

2. Severe trauma, including trauma patients with ISS score ≥ 16;

3. Time from trauma to admission <24h.

Exclusion Criteria

1. Patients who complicated with underlying diseases, such as malignant tumor and diabetes mellitus;

2. Patients with important organ dysfunction before trauma;

3. The investigator considers not appropriate for enrollment. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Feifei Jin

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

RT study

Identifier Type: -

Identifier Source: org_study_id