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

Study Overview
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Brief Summary
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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
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Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: 24 months of inclusion of unaccompanied patients
* Other: 18 months of inclusion of unaccompanied patients
* Other: 12 months of inclusion of unaccompanied patients
* Other: 6 months of inclusion of unaccompanied patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: standard care: accompanied patients Remote surveillance: unaccompanied patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Group1<br>In group 1: 5 centers will be randomized for the inclusion of unaccompanied patients for 24 months | Other: 24 months of inclusion of unaccompanied patients<br>* 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)<br>|
| Experimental: Experimental: Group2<br>In group 2: 5 other centers will be randomized for the inclusion of unaccompanied patients for 18 months | Other: 18 months of inclusion of unaccompanied patients<br>* 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)<br>|
| Experimental: Experimental: Group3<br>In group 3: 5 other centers will be randomized for the inclusion of unaccompanied patients for 12 months | Other: 12 months of inclusion of unaccompanied patients<br>* 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)<br>|
| Experimental: Experimental: Group4<br>In group 4: 5 other centers will be randomized for the inclusion of unaccompanied patients for 6 months | Other: 6 months of inclusion of unaccompanied patients<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period |  | 30 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative complications requiring re-hospitalization |  | 1 month | 
| Functional improvement at 1 month as assessed by the Rutherford classification |  | 1 month | 
| Assessment of patient anxiety using the HAS anxiety questionnaire |  | pre-procedure | 
| Assessment of patient anxiety using the HAS anxiety questionnaire |  | immediately after procedure | 
| Assessment of patient anxiety using the HAS anxiety questionnaire |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulatory, accompanied patient, unaccompanied patient