Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.
NCT ID: NCT05756491
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2023-04-11
2026-04-11
Brief Summary
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The endovascular technique has several advantages. First, it is a minimally invasive treatment, most often performed under local anesthesia. Secondly, the duration of the procedure and the length of hospitalization are reduced. In addition, the peri-operative morbidity and mortality is extremely low.
In France, for many years, public health policies have encouraged the development of outpatient hospitalization. Endovascular treatment allows the development of outpatient care. The French Society of Vascular and Endovascular Surgery (SCVE) was the first European society to publish recommendations concerning the outpatient management of endovascular treatment of PAD. These recommendations aim to promote the development of outpatient treatment by providing a framework for practitioners wishing to offer this type of management.
Concerning the patient and according to the SCVE recommendations, all types of occlusive arterial lesions of the lower limbs can be managed on an outpatient basis and only patients with severe comorbidities are excluded from this type of hospitalization. In addition, various studies have shown the safety of outpatient hospitalization for PAD. The absence of an accompanying person on the night following the procedure is considered an exclusion criterion for outpatient care.
The objective of this Stepped-wedge Cluster Randomized Controlled Trial is to increase the use of outpatient hospitalization for endovascular treatment of PAD by proposing a care pathway adapted to people without an accompanying person on the night of the procedure at home.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Experimental: Group1
In group 1: 5 centers will be randomized for the inclusion of unaccompanied patients for 24 months
24 months of inclusion of unaccompanied patients
inclusion for 6 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 24 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
Experimental: Group2
In group 2: 5 other centers will be randomized for the inclusion of unaccompanied patients for 18 months
18 months of inclusion of unaccompanied patients
inclusion for 12 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 18 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
Experimental: Group3
In group 3: 5 other centers will be randomized for the inclusion of unaccompanied patients for 12 months
12 months of inclusion of unaccompanied patients
inclusion for 18 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 12 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
Experimental: Group4
In group 4: 5 other centers will be randomized for the inclusion of unaccompanied patients for 6 months
6 months of inclusion of unaccompanied patients
inclusion for 24 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 6 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
Interventions
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24 months of inclusion of unaccompanied patients
inclusion for 6 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 24 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
18 months of inclusion of unaccompanied patients
inclusion for 12 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 18 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
12 months of inclusion of unaccompanied patients
inclusion for 18 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 12 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
6 months of inclusion of unaccompanied patients
inclusion for 24 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 6 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)
Eligibility Criteria
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Inclusion Criteria
* Procedure listed in the Common Classification of Medical Procedures
* Patient with a good understanding of the constraints of the study
* Patient with an ASA score of 1 to 3 (stable)
* Patient registered with the social security system
* Patient living less than 1 hour by car from the care facility or from a care facility able to care for this type of patient
* Patient willing to remain hospitalized if necessary
For accompanied patients only:
\- Patient does not object to the processing of his or her data
Only for isolated patients:
* Patient with free, informed and written consent
* Patient agreeing to wear the remote monitoring device at discharge from the outpatient revascularization hospitalization
* Patient agreeing to the processing of his or her personal data with the remote monitoring provider
* Patient not living in an area not served by a cell phone network (white zone)
Exclusion Criteria
* Acute ischemia of the lower limbs
* Patient already included in ABALONE (2nd inclusion impossible)
* Patient already included in a type 1 interventional research protocol
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Locations
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Chu Jean Minjoz
Besançon, , France
Centre Hospitalier de Béziers,
Béziers, , France
Hopital Universitaire Ambroise Paré,
Boulogne-Billancourt, , France
CHRU Cavale Blanche
Brest, , France
Chu Cote de Nacre
Caen, , France
Hôpital Universitaire Gabriel Montpied
Clermont-Ferrand, , France
Pôle médical du Grand large,
Décines-Charpieu, , France
Hopital Le Bocage,
Dijon, , France
Hopital Prive Dijon Bourgogne
Dijon, , France
Clinique Mutualiste Porte de L'Orient
Lorient, , France
Chu de Nantes
Nantes, , France
Hopital Prive Du Confluent
Nantes, , France
Chu de Nice,
Nice, , France
Hôpital Saint Joseph
Paris, , France
Polyclinique Francheville,
Périgueux, , France
Clinique de L'Europe
Rouen, , France
Centre Hospitalier Yves Le Foll-
Saint-Brieuc, , France
Centre Hospitalier Privé SAINT GREGOIRE
Saint-Grégoire, , France
Clinique Esquirol-Saint-Hilaire,
Saint-Hilaire, , France
Médipôle Lyon Villeurbanne,
Villeurbanne, , France
Countries
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Central Contacts
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Other Identifiers
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2022-A01201-42
Identifier Type: -
Identifier Source: org_study_id
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