Clinical trial NCT03605355: Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes
Official title: Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transient Ischemic Attack
Keywords: minor stroke
cost-effectiveness
feasibility
day clinic
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients, to adapt to the recent change in the typology of new ischemic stroke in Western Europe, which for the most part are transient (30%) or minor ischemic strokes (35%). %).

The profile of these patients is indeed compatible with outpatient care which should lead to the adaptation of the offer of care.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The average cost-effectiveness ratio at 3 month
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of full cost collection
timeFrame: 1 year
measure: Concordance between monitoring data collected in different database
timeFrame: 1 year
measure: Recurrence rate of cerebro and cardiovascular events at 7 days
timeFrame: 7 days
measure: Recurrence rate of cerebro and cardiovascular events at 3 months
timeFrame: 3 months
measure: Recurrence rate of cerebro and cardiovascular events at one year
timeFrame: one year
measure: Average cost-effectiveness ratio at one year
timeFrame: one year
measure: Percentage of patients treated in TIA clinic who had first medical contact with a senior
timeFrame: 1 day
measure: Percentage of patients with statin prescription at discharge
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Hélène Derumeaux-Burel, MD
role: PRINCIPAL_INVESTIGATOR
References: