Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes

Transient Ischemic Attack Clinical Trial

— MEDECO-AIT  

Official title:

Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03605355
• Other study ID #: RC31/17/0349
• Secondary ID: 2018-A01444-51
• Status: Not yet recruiting
• Start date: September 7, 2019
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: University Hospital, Toulouse
• Contact: Hélène Derumeaux-Burel, MD
• Phone: 05 61 77 87 75
• Email: derumeaux.h[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France.

Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.

Description:

Only two hospitals in France can take care patients with TIA or MS in an outpatient setting :Bichat hospital in Paris and Toulouse University Hospital. The effectiveness of this management has been demonstrated since recurrence stroke risk is reduced by 80% at one year. An English study (EXPRESS study) [2] showed a gain of 624 pounds with an ambulatory management compared to a conventional one. No studies are available in France on this subject.

The aim of this study is to test the feasibility of a collection of medical and economic data on a prospective way. The investigators collect medical (Cerebrovascular events, Stroke) and economic (direct and indirect costs) data concerning patients who were managed in TIA clinic in Toulouse Hospital. The medical data will be compiled with available French and International literature. The economic data will be compiled with available data in PMSI and health insurance database. This study aims to prepare a multicenter cohort to compare the cost effectiveness ratio between ambulatory and conventional management.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalization in the TIA clinic in Toulouse Hospital (a day clinic)

• Having presented within the previous 7 days a transient ischemic attack or a minor stroke

• Affiliated to a social protection system

• To have given no opposition to participation in the study

Exclusion Criteria:

• Patients with a transient ischemic attack - mimic (such as migraine or seizure)

• Patients under protection of justice

• Pregnant and / or breastfeeding woman

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Transient Ischemic Attack

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average cost-effectiveness ratio at 3 month	The average cost-effectiveness ratio at 3 month where the effectiveness is the 3-month cerebro vascular event rate and the costs taken into account are medical and non-medical direct costs and indirect costs limited to work stoppages.	3 months
Secondary	Percentage of full cost collection	Percentage of patients for whom total direct medical, direct non-medical, and indirect costs could be collected by comparing with health insurance data	1 year
Secondary	Concordance between monitoring data collected in different database	Concordance between prospectively collected monitoring data, supplemented by data from the PMSI database of Toulouse University Hospital and data extracted from the health insurance database via NIR.	1 year
Secondary	Recurrence rate of cerebro and cardiovascular events at 7 days	Recurrence rate of cerebro and cardiovascular events at 7 days : Stroke, myocardial infarction, vascular death within 30 days of stroke or MI	7 days
Secondary	Recurrence rate of cerebro and cardiovascular events at 3 months	Recurrence rate of cerebro and cardiovascular events at 3 months : Stroke, myocardial infarction, vascular death within 30 days of stroke or MI	3 months
Secondary	Recurrence rate of cerebro and cardiovascular events at one year	Recurrence rate of cerebro and cardiovascular events at one year : Stroke, myocardial infarction, vascular death within 30 days of stroke or MI	one year
Secondary	Average cost-effectiveness ratio at one year	The average cost - effectiveness ratio with the criterion of effectiveness the recurrence rate for cardiovascular events at one year (stroke, myocardial infarction, vascular death occurring within 30 days after a stroke or an IDM), and as cost criteria, direct medical and non-medical costs and indirect costs limited to work stoppages	one year
Secondary	Percentage of patients treated in TIA clinic who had first medical contact with a senior	Percentage of patients attending the AIT Clinic who had first medical contact with a senior neurology	1 day
Secondary	Percentage of patients with statin prescription at discharge	Percentage of patients with statin prescription at discharge	1 day