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Clinical Trials/NCT02814760
NCT02814760
Completed
N/A

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

Hospices Civils de Lyon1 site in 1 country3,238 target enrollmentJuly 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Ischemic Stroke
Sponsor
Hospices Civils de Lyon
Enrollment
3238
Locations
1
Primary Endpoint
Admission- arrival at stroke unit time
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2012
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Admission- arrival at stroke unit time

Time Frame: Hour 24

Admission - brain imaging time

Time Frame: Hour 24

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

Time Frame: Hour 24

Brain imaging time - arrival at stroke unit time

Time Frame: Hour 24

Secondary Outcomes

  • Proportion of cerebral hemorrhage after thrombolysis(Hour 24)
  • Number of ED where the clinical pathway was actually set up(1 year)
  • proportion of patients thrombolysed(Hour 24)
  • Proportion of deaths(Hour 24)
  • Proportion of professionals who received training(1 year)
  • Number of collective trainings organized in each ED by the local trainers(1 year)
  • proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)(Hour 24)

Study Sites (1)

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