Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region

Study Overview
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Brief Summary
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Trauma patient management concerns more than 140,000 patients per year in France. PACA Regional Emergency Observatory (ORU) has issued recommendations to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the golden hour concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by pre-hospital doctor and 90 minutes for patients deemed potentially serious. FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days). The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Detailed Description
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Trauma patient management concerns more than 140,000 patients per year in France. Grenoble region was the first one to organize its trauma network around trauma centers ranked by levels (from level 1, the most complete technical platform, to level 3). PACA Regional Health Agency (ARS) set up its dedicated line for severe trauma patients in 2014 based on a regional multi-professional group recommendations, the PACA Regional Emergency Observatory (ORU), in order to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours (recommendations available online: https://ies-sud.fr/bonnes-pratiques/). This network suggests a care pathway setting objectives at each stage with operating requirements. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the golden hour concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). In PACA region, level 1 technical platforms are North Hospital and Timone Hospital (AP-HM, Marseille, 13) and Sainte Anne Hospital (Toulon, 83). Levels 2 are Sainte Musse Hospital (Toulon, 83), Saint Joseph Hospital (Marseille, 13) and Avignon Hospital (84) and levels 3 correspond to all other hospitals in the region. Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by the pre-hospital doctor and 90 minutes for patients deemed potentially serious. FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days). The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Official Title
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Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region

Conditions
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Trauma

Intervention / Treatment
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* Other: Pre-hospital and hospital care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Any patient with a severe trauma requiring SMUR activation. Trauma defined by the appearance of a lesion following a fall, a road accident, a burn or the penetration of a foreign body and regulated by one of the PACA region SAMU centres (84, 83, 13, 04) Exclusion Criteria: Opposition of the patient, family member or trusted person Patient under legal protection (guardianship or curatorship)

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patient with a severe trauma requiring SMUR activation<br>Trauma defined by appearance of lesions following a fall, a road accident, a burn or the penetration of a foreign body and regulated by one of the SAMU PACA region centres (84, 83, 13, 04) | Other: Pre-hospital and hospital care<br>* Pre-hospital care not exceeding 60 min and a whole body CT scan within 45 min for patients categorized as unstable or critical by the pre-hospital doctor and 90 minutes for patients deemed potentially serious.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether compliance with the golden hour, pre-hospital delay recommended by PACA ORU, influences severe trauma patient vital status. | Pre-hospital management duration (from the call to the SAMU to arrival at trauma centres) will be derived according to PACA ORU recommendation (time inferior or superior to 1 hour), and will then be related to patient's vital status at 24 hours. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether adherence to ORU PACA recommendations in terms of pre-hospital management delays influences severe trauma patient vital status at day 28 | Pre-hospital management duration (from the call to the SAMU to arrival at trauma centres) will be derived according to PACA ORU recommendation (inferior or superior 1 hour), and will then be related to patient's vital status at day 28. | 28 days | 
| To assess whether transport by suitable vehicle to appropriate health facility recommended by the ORU PACA influences the vital status of severe trauma patients. | The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to transport by suitable vehicle to appropriate health facility | 28 days | 
| To assess whether accident categorization and assessment transfer to the SAMU recommended by the ORU PACA influences the vital status of severe trauma patients. | The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to accident categorization and assessment transfer to the SAMU | 28 days | 
| To assess whether management on accident scene recommended by the ORU PACA influences the vital status of severe trauma patients. | The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to management on accident scene | 28 days | 
| To assess whether overall assessment of severity recommended by the ORU PACA influences the vital status of severe trauma patients. | The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to Overall assessment of severity. | 28 days | 
| To assess whether time required to perform a whole body CT scan recommended by the ORU PACA influences the vital status of severe trauma patients. | The influence of adherence to ORU PACA recommendations on severe trauma patient vital status (at 24 hours and 28 days after trauma) will be evaluated according to time required to perform a whole body CT scan. | 28 days | 
| To analyze risk factors for non-adherence to recommendations | The risk factors for non-adherence to recommendations will be identified through primary and first secondary outcome criteria analysis. They will then be described (structural, patient-related). | 28 days | 
| To analyze errors in referring severe trauma patients to an appropriate care facility | Identification and analysis of the reasons for mis-referrals of severe trauma patients to an approved care facility. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe trauma, PACA ORU recommendations, golden hour, emergency rapid response unit, hospital care, prognosis