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Completed

NCT Number: NCT02814760

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

training of emergency professionals to acute stroke management

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).

Primary outcomes

  1. Admission - brain imaging time

    Time frame: Hour 24

  2. Admission- arrival at stroke unit time

    Time frame: Hour 24

  3. Brain imaging time - arrival at stroke unit time

    Time frame: Hour 24

  4. Admission period - thrombolysis time (door-to-needle time)

    Time frame: Hour 24

Secondary outcomes

  1. proportion of patients thrombolysed

    Time frame: Hour 24

    Assessment of the overall impact of actions on patients management : on the proportion of patients thrombolysed

  2. Proportion of cerebral hemorrhage after thrombolysis

    Time frame: Hour 24

    Assessment of the overall impact of actions on patients management : on the proportion of cerebral hemorrhage after thrombolysis

  3. Proportion of deaths

    Time frame: Hour 24

    Assessment of the overall impact of actions on patients management : on the proportion of deaths

  4. proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)

    Time frame: 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)

  5. Proportion of professionals who received training

    Time frame: 1 year

    Training course feasibility measured with the proportion of professionals in each ED who received training by the local trainers

  6. Number of ED where the clinical pathway was actually set up

    Time frame: 1 year

    Training course feasibility measured with the number of ED where the clinical pathway was actually set up

  7. Number of collective trainings organized in each ED by the local trainers

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: AVC-II

Important dates

Study start
2010
Primary completion
2012
First posted
Jun 28, 2016
Registry last updated
Jun 28, 2016

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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