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

NCT ID: NCT02814760

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3238 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Brief Summary

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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

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Conditions

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Acute Ischemic Stroke

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-intervention group (Control group)

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 before the intervention (training of emergency professionals to acute stroke management) in this ED or stroke units.

No interventions assigned to this group

Post-intervention group (Training course group)

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.

training of emergency professionals to acute stroke management

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Yves Gueugniaud, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Groupement Hospitalier Edouard Herriot - Urgences Médicales et Psychiatriques Adultes - Pavillon N, 5 Place d'Arsonval

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29321338 (View on PubMed)

Other Identifiers

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D50676

Identifier Type: -

Identifier Source: org_study_id

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