Clinical trial NCT02814760: Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)
Official title: Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
stepped-wedge
interactive training
implementation
emergency department
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 3238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute stroke suspicion patients consulting in emergency department

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.


Eligibility criteria: 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

Primary outcomes:
measure: Admission - brain imaging time
timeFrame: Hour 24
measure: Admission- arrival at stroke unit time
timeFrame: Hour 24
measure: Brain imaging time - arrival at stroke unit time
timeFrame: Hour 24
measure: Admission period - thrombolysis time (door-to-needle time)
timeFrame: Hour 24
Secondary outcomes:
measure: proportion of patients thrombolysed
timeFrame: Hour 24
measure: Proportion of cerebral hemorrhage after thrombolysis
timeFrame: Hour 24
measure: Proportion of deaths
timeFrame: Hour 24
measure: proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)
timeFrame: Hour 24
measure: Proportion of professionals who received training
timeFrame: 1 year
measure: Number of ED where the clinical pathway was actually set up
timeFrame: 1 year
measure: Number of collective trainings organized in each ED by the local trainers
timeFrame: 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Groupement Hospitalier Edouard Herriot - Urgences Médicales et Psychiatriques Adultes - Pavillon N, 5 Place d'Arsonval
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre-Yves Gueugniaud, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haesebaert J, Nighoghossian N, Mercier C, Termoz A, Porthault S, Derex L, Gueugniaud PY, Bravant E, Rabilloud M, Schott AM; AVC II Trial group. Improving Access to Thrombolysis and Inhospital Management Times in Ischemic Stroke: A Stepped-Wedge Randomized Trial. Stroke. 2018 Feb;49(2):405-411. doi: 10.1161/STROKEAHA.117.018335. Epub 2018 Jan 10.