Clinical trial NCT05756491: Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.
Official title: Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: ambulatory
accompanied patient
unaccompanied patient
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: standard care: accompanied patients Remote surveillance: unaccompanied patients
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* For all patients, the inclusion criteria are:
* Patient with symptomatic PAD (Rutherford 1-5) requiring endovascular revascularization that can be performed on an outpatient basis
* 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:

* - Disorders of hemostasis
* 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

Primary outcomes:
measure: Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period
timeFrame: 30 month
Secondary outcomes:
measure: Number of postoperative complications requiring re-hospitalization
timeFrame: 1 month
measure: Functional improvement at 1 month as assessed by the Rutherford classification
timeFrame: 1 month
measure: Assessment of patient anxiety using the HAS anxiety questionnaire
timeFrame: pre-procedure
measure: Assessment of patient anxiety using the HAS anxiety questionnaire
timeFrame: immediately after procedure
measure: Assessment of patient anxiety using the HAS anxiety questionnaire
timeFrame: Day 7
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chu Jean Minjoz
city: Boulogne Billancourt
country: France
facility: Hopital Universitaire Ambroise Paré,
city: Brest
country: France
facility: CHRU Cavale Blanche
city: Béziers
country: France
facility: Centre Hospitalier de Béziers,
city: Caen
country: France
facility: Chu Cote de Nacre
city: Clermont-Ferrand
country: France
facility: Hôpital Universitaire Gabriel Montpied
city: Dijon
country: France
facility: Hopital Le Bocage,
city: Dijon
country: France
facility: Hopital Prive Dijon Bourgogne
city: Décines-Charpieu
country: France
facility: Pôle médical du Grand large,
city: Lorient
country: France
facility: Clinique Mutualiste Porte de L'Orient
city: Nantes
country: France
facility: Chu de Nantes
city: Nantes
country: France
facility: Hopital Prive Du Confluent
city: Nice
country: France
facility: Chu de Nice,
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Périgueux
country: France
facility: Polyclinique Francheville,
city: Rouen
country: France
facility: Clinique de L'Europe
city: Saint Gregoire
country: France
facility: Centre Hospitalier Privé SAINT GREGOIRE
city: Saint-Brieuc
country: France
facility: Centre Hospitalier Yves Le Foll-
city: Saint-Hilaire
country: France
facility: Clinique Esquirol-Saint-Hilaire,
city: Villeurbanne
country: France
facility: Médipôle Lyon Villeurbanne,
Study officials:
References: