Clinical trial NCT02581150: Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease
Official title: Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Outpatient hospitalization
Randomized trial
Peripheral arterial disease
Endovascular treatment
Health Economics
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-10-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.

Detailed description: Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.

Eligibility criteria: Inclusion Criteria:

* Patients limping
* Patients with PAD requiring endovascular management
* Patients with stabilized level 1 to 3 ASA (classification of the American Society of Anesthesiology)
* Ability to walking
* Endovascular indicated and compatible with an introducer 5F to 7F
* Agreeing to participate in the study and having signed an informed consent.
* Agreeing to lend itself to a post-operative monitoring a duration of 30 days
* Social Insured

Exclusion Criteria:

* No possibility of an outpatient management
* Previous participation in the AMBUVASC study
* Refusal of patient to participate in the study
* Patient with hemostasis disorders
* Acute Ischemia
* Using a more 7F introducer
* Radial or brachial puncture
* Antegrade femoral puncture
* Contraindication to endovascular treatment
* Less than one month life expectancy
* Participation in another clinical trial

Primary outcomes:
measure: Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms
timeFrame: 3 months
Secondary outcomes:
measure: Budget impact analysis
timeFrame: 5 years
measure: Complication rates
timeFrame: 1 month
measure: Functional improvement
timeFrame: 1 month
measure: Time period to back-to-work
timeFrame: 1 month
Other outcomes:
Locations:
city: Besançon
country: France
facility: Besançon University Hospital
city: Colmar
country: France
facility: Colmar Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Fontaine les Dijon
country: France
facility: Clinique de Fontaine
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: Marseille
country: France
facility: Marseille University Hospital (La Timone)
city: Marseille
country: France
facility: Marseille University Hospital (North)
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen Clinique de l'Europe
city: Saint-Etienne
country: France
facility: Saint-Etienne University Hospital
Study officials:
affiliation: University Hospital of Nantes, France
name: Yann Gouëffic, Md., PhD.
role: PRINCIPAL_INVESTIGATOR
References: