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

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

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 Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yann Goueffic; Phone Number: +33 (0)1 44 12 75 91; Email: ygoueffic@ghpsj.fr
• Study Contact Backup: Name: Florence LECERF; Phone Number: +33 (0) 1 40 94 25 17; Email: f.lecerf@ghpsj.fr

Study Locations

• France
  • Besançon, France, 25030
    • Recruiting
    • Chu Jean Minjoz
    • Principal Investigator: Simon Rinckenbach
  • Boulogne Billancourt, France, 92100
    • Recruiting
    • Hopital Universitaire Ambroise Paré,
    • Principal Investigator: Raphael COSCAS
  • Brest, France, 29200
    • Recruiting
    • CHRU Cavale Blanche
    • Principal Investigator: Bahaa Nasr
  • Béziers, France, 34500
    • Recruiting
    • Centre Hospitalier de Béziers,
    • Principal Investigator: Sebastien Cazaban
  • Caen, France, 14000
    • Recruiting
    • CHU Côte de Nacre
    • Principal Investigator: Ludovic Berger
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Hôpital Universitaire Gabriel Montpied
    • Principal Investigator: Fabien THAVEAU
  • Dijon, France, 21000
    • Recruiting
    • Hôpital privé Dijon Bourgogne
    • Principal Investigator: Jean Luc Pin
  • Dijon, France, 21000
    • Recruiting
    • Hopital Le Bocage,
    • Principal Investigator: Eric STEINMETZ
  • Décines-Charpieu, France, 69150
    • Recruiting
    • Pôle médical du Grand large,
    • Principal Investigator: Bertrand Edé
  • Lorient, France, 56324
    • Recruiting
    • Clinique Mutualiste Porte de L'Orient
    • Principal Investigator: Jean Baptiste BOCQUEL
  • Nantes, France, 44000
    • Recruiting
    • CHU de Nantes
    • Principal Investigator: Blandine Maurel
  • Nantes, France, 44000
    • Recruiting
    • Hôpital Privé du Confluent
    • Principal Investigator: Stéphane BRENUGAT
  • Nice, France, 06000
    • Recruiting
    • Chu de Nice,
    • Principal Investigator: Nirvana Sadaghianloo
  • Paris, France, 75014
    • Recruiting
    • Hopital Saint Joseph
    • Principal Investigator: Yann Goueffic
  • Périgueux, France, 24000
    • Recruiting
    • Polyclinique Francheville,
    • Principal Investigator: Nicolas Diard
  • Rouen, France, 76100
    • Recruiting
    • Clinique de l'Europe
    • Principal Investigator: Jean Sabatier
  • Saint Gregoire, France, 35760
    • Recruiting
    • Centre Hospitalier Privé Saint Grégoire
    • Principal Investigator: Laurent Ferté
  • Saint-Brieuc, France, 22027
    • Recruiting
    • Centre Hospitalier Yves Le Foll-
    • Principal Investigator: Christophe Robin
  • Saint-Hilaire, France, 47000
    • Recruiting
    • Clinique Esquirol-Saint-Hilaire,
    • Principal Investigator: Romain Belmonte
  • Villeurbanne, France, 69100
    • Recruiting
    • Médipôle Lyon Villeurbanne,
    • Principal Investigator: Thibault Streichenberger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Group1; 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; 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: Experimental: Group2; 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; 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: Experimental: Group3; 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; 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: Experimental: Group4; 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; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): April 11, 2026
• Study Completion (Estimated): April 11, 2026

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ambulatory; accompanied patient; unaccompanied patient
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2022-A01201-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No