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RECRUITING
NCT05756491
NA

Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.

Sponsor: Fondation Hôpital Saint-Joseph

View on ClinicalTrials.gov

Summary

In Westernized countries, the prevalence of peripheral arterial disease (PAD) is estimated at 15-20% of subjects over 70 years of age and is increasing considerably because of the aging of the population and the increasing prevalence of diabetes and renal insufficiency. In response to this increase in incidence, vascular surgeons must develop innovative treatments that minimize the use of resources in a context of budgetary constraints, in patients who are increasingly well informed, while maintaining the safety and effectiveness of the procedures performed. 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.

Official title: Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2023-04-11

Completion Date

2026-04-11

Last Updated

2024-01-16

Healthy Volunteers

No

Interventions

OTHER

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)

OTHER

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)

OTHER

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)

OTHER

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)

Locations (20)

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