Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Other: training of emergency professionals to acute stroke management

• Registration Number: NCT02814760
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) (Porthault et al. 2013) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of patients arrived in the emergency department too late to be thrombolysed. However, among the subset of ischemic stroke patients who reach emergency department less than 3 hours after symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis, only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED professional's knowledge and skills and to develop together efficient clinical pathway would decrease door-to imaging time and consequently door-to needle time and eventually improve overall thrombolysis rate.

The investigators have conducted a cluster randomized controlled stepped wedge trial. All adult patients with suspected stroke arriving in one of the participating ED were included in the study along five successive four-month periods. The program featured: development of written materials (booklets) and video (film), and one day session of standardized training for trainers, at least one nurse and one physician of all EDs, with formal presentation to improve knowledge, and simulation to improve skills for using the "FAST" tool (nurses) and the "NIHSS" score (ED physicians). Additionally, a clinical pathway was developed to adapt general evidence based guidelines to the local organization. The primary outcome is the door-to imaging time.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-07
• Status Verified: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3238

Inclusion Criteria

• All adult patients admitted to one of the participating ED for suspected ischemic stroke less than or equal to 4 hours from symptoms onset were included in the study.

Exclusion Criteria

• age below 18
• admission to the ED more than 4 hours after symptoms onset or unknown time of first symptoms

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-intervention group (Training course group)	training of emergency professionals to acute stroke management	AVC-II trial involves 18 ED and 10 stroke units in the Rhone-Alpes and Bourgogne area. All adult patients admitted to one of the participating ED for suspected ischemic stroke less than or equal to 4 hours from symptoms onset were included in the study. Patients of this group are included after the intervention (training of emergency professionals to acute stroke management) in this ED or stroke units.

Primary Outcome Measures

Name	Time	Method
Admission- arrival at stroke unit time	Hour 24
Admission - brain imaging time	Hour 24
Admission period - thrombolysis time (door-to-needle time)	Hour 24
Brain imaging time - arrival at stroke unit time	Hour 24

Secondary Outcome Measures

Name	Time	Method
Proportion of cerebral hemorrhage after thrombolysis	Hour 24	Assessment of the overall impact of actions on patients management : on the proportion of cerebral hemorrhage after thrombolysis
Number of ED where the clinical pathway was actually set up	1 year	Training course feasibility measured with the number of ED where the clinical pathway was actually set up
proportion of patients thrombolysed	Hour 24	Assessment of the overall impact of actions on patients management : on the proportion of patients thrombolysed
Proportion of deaths	Hour 24	Assessment of the overall impact of actions on patients management : on the proportion of deaths
Proportion of professionals who received training	1 year	Training course feasibility measured with the proportion of professionals in each ED who received training by the local trainers
Number of collective trainings organized in each ED by the local trainers	1 year	Training course feasibility measured with the number of ED where the clinical pathway was actually set up, and the number of collective trainings organized in each ED by the local trainers
proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)	Hour 24	Assessment of the overall impact of actions on patients management : on the proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)

Trial Locations

Locations (1)

Groupement Hospitalier Edouard Herriot - Urgences Médicales et Psychiatriques Adultes - Pavillon N, 5 Place d'Arsonval; 🇫🇷 Lyon, France