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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
2,000
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)
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)
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)
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)
Chu Jean Minjoz
Besançon, France
RECRUITINGCentre Hospitalier de Béziers,
Béziers, France
RECRUITINGHopital Universitaire Ambroise Paré,
Boulogne-Billancourt, France
RECRUITINGCHRU Cavale Blanche
Brest, France
RECRUITINGChu Cote de Nacre
Caen, France
RECRUITINGHôpital Universitaire Gabriel Montpied
Clermont-Ferrand, France
RECRUITINGPôle médical du Grand large,
Décines-Charpieu, France
RECRUITINGHopital Le Bocage,
Dijon, France
RECRUITINGHopital Prive Dijon Bourgogne
Dijon, France
RECRUITINGClinique Mutualiste Porte de L'Orient
Lorient, France
RECRUITING...and 10 more locations
Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period
Time frame: 30 month
Number of postoperative complications requiring re-hospitalization
Time frame: 1 month
Functional improvement at 1 month as assessed by the Rutherford classification
Time frame: 1 month
Assessment of patient anxiety using the HAS anxiety questionnaire
Time frame: pre-procedure
Assessment of patient anxiety using the HAS anxiety questionnaire
Time frame: immediately after procedure
Assessment of patient anxiety using the HAS anxiety questionnaire
Time frame: Day 7
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