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

Acute Ischemic Stroke Clinical Trial

— AVC-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814760
• Other study ID #: D50676
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 27, 2016
• Start date: July 2010

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3238
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Other:
• training of emergency professionals to acute stroke management
The training program aiming at improving the timeliness of care of acute stroke patients in ED was designed for triage ED nurses and ED physicians and it was based on 3 sub-objectives: Improving knowledge and skills of triage nurses to recognize patients with stroke symptoms Improving knowledge and skills of ED physicians to recognize stroke symptoms, to realize a good quality neurological examination and be able to measure the NIHSS (National Institute of Health Stroke Score), to have a better understanding of the physiopathology of ischemic stroke and thrombolysis, and to have a better understanding of the consequences of wasted time for patients Developing, together with other hospital professionals involved in acute stroke management, a clinical pathway adapted to the local characteristics an organization (ED organization optimization, management steps, connections between ED, radiology unit and stroke unit, thrombolysis organization).

Locations

Country	Name	City	State
France	Groupement Hospitalier Edouard Herriot - Urgences Médicales et Psychiatriques Adultes - Pavillon N, 5 Place d'Arsonval	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission - brain imaging time		Hour 24	No
Primary	Admission- arrival at stroke unit time		Hour 24	No
Primary	Brain imaging time - arrival at stroke unit time		Hour 24	No
Primary	Admission period - thrombolysis time (door-to-needle time)		Hour 24	No
Secondary	proportion of patients thrombolysed	Assessment of the overall impact of actions on patients management : on the proportion of patients thrombolysed	Hour 24	No
Secondary	Proportion of cerebral hemorrhage after thrombolysis	Assessment of the overall impact of actions on patients management : on the proportion of cerebral hemorrhage after thrombolysis	Hour 24	No
Secondary	Proportion of deaths	Assessment of the overall impact of actions on patients management : on the proportion of deaths	Hour 24	No
Secondary	proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)	Assessment of the overall impact of actions on patients management : on the proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)	Hour 24	No
Secondary	Proportion of professionals who received training	Training course feasibility measured with the proportion of professionals in each ED who received training by the local trainers	1 year	No
Secondary	Number of ED where the clinical pathway was actually set up	Training course feasibility measured with the number of ED where the clinical pathway was actually set up	1 year	No
Secondary	Number of collective trainings organized in each ED by the local trainers	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	1 year	No