Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.
ABALONE
1 other identifier
interventional
2,000
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Typical duration for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedStudy Start
First participant enrolled
April 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2026
CompletedJanuary 16, 2024
January 1, 2024
3 years
January 20, 2023
January 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period
30 month
Secondary Outcomes (5)
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
Study Arms (4)
Experimental: Group1
EXPERIMENTALIn group 1: 5 centers will be randomized for the inclusion of unaccompanied patients for 24 months
Experimental: Group2
EXPERIMENTALIn group 2: 5 other centers will be randomized for the inclusion of unaccompanied patients for 18 months
Experimental: Group3
EXPERIMENTALIn group 3: 5 other centers will be randomized for the inclusion of unaccompanied patients for 12 months
Experimental: Group4
EXPERIMENTALIn group 4: 5 other centers will be randomized for the inclusion of unaccompanied patients for 6 months
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- \- Disorders of hemostasis
- Acute ischemia of the lower limbs
- Patient already included in a type 1 interventional research protocol
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Chu Jean Minjoz
Besançon, 25030, France
Centre Hospitalier de Béziers,
Béziers, 34500, France
Hopital Universitaire Ambroise Paré,
Boulogne-Billancourt, 92100, France
CHRU Cavale Blanche
Brest, 29200, France
Chu Cote de Nacre
Caen, 14000, France
Hôpital Universitaire Gabriel Montpied
Clermont-Ferrand, 63003, France
Pôle médical du Grand large,
Décines-Charpieu, 69150, France
Hopital Le Bocage,
Dijon, 21000, France
Hopital Prive Dijon Bourgogne
Dijon, 21000, France
Clinique Mutualiste Porte de L'Orient
Lorient, 56324, France
Chu de Nantes
Nantes, 44000, France
Hopital Prive Du Confluent
Nantes, 44000, France
Chu de Nice,
Nice, 06000, France
Hôpital Saint Joseph
Paris, 75014, France
Polyclinique Francheville,
Périgueux, 24000, France
Clinique de L'Europe
Rouen, 76100, France
Centre Hospitalier Yves Le Foll-
Saint-Brieuc, 22027, France
Centre Hospitalier Privé SAINT GREGOIRE
Saint-Grégoire, 35760, France
Clinique Esquirol-Saint-Hilaire,
Saint-Hilaire, 47000, France
Médipôle Lyon Villeurbanne,
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2023
First Posted
March 6, 2023
Study Start
April 11, 2023
Primary Completion
April 11, 2026
Study Completion
April 11, 2026
Last Updated
January 16, 2024
Record last verified: 2024-01