Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes (MEDECO-AIT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Transient Ischemic Attack

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Hélène Derumeaux-Burel, MD; Phone Number: 05 61 77 87 75; Email: derumeaux.h@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse
    • Contact: Hélène Derumeaux-Burel, MD; Phone Number: 33 05 61 77 87 75; Email: derumeaux.h@chu-toulouse.fr
    • Contact: Isabelle Olivier, PhD; Phone Number: 05 61 77 70 51; Email: olivier.i@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Percentage of patients with statin prescription at discharge	Percentage of patients with statin prescription at discharge	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Hélène Derumeaux-Burel, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): September 7, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: minor stroke; feasibility; cost-effectiveness; day clinic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: RC31/17/0349; 2018-A01444-51 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No