Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease

Peripheral Arterial Disease Clinical Trial

— AMBUVASC  

Official title:

Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581150
• Other study ID #: RC15_0044
• Secondary ID: PRME-14-0444
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Treatment of Occlusive Arterial Disease
Regarding the intervention, the technique used during the diagnostic and/or therapeutic procedure shall be left to the operator's discretion, except the use of an arterial closure device (ACD). In the ambulatory hospitalisation arm, the ACD use will be mandatory. In the conventional hospitalisation arm, ACD will be used at the discretion of the interventionalist.

Locations

Country	Name	City	State
France	Besançon University Hospital	Besançon
France	Colmar Hospital	Colmar
France	Dijon University Hospital	Dijon
France	Clinique de Fontaine	Fontaine les Dijon
France	La Roche sur Yon Hospital	La Roche sur Yon
France	Marseille University Hospital (La Timone)	Marseille
France	Marseille University Hospital (North)	Marseille
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes
France	Rouen Clinique de l'Europe	Rouen
France	Saint-Etienne University Hospital	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms	The objective of the study is to perform a cost-utility analysis comparing outpatient surgery to conventional hospitalization in endovascular treatment of occlusive arterial disease. The analysis will be conducted from a society's perspective using a one-month time horizon following the date of intervention (and 2 months before intervention). A microcosting approach will be used to estimate the cost of the surgical intervention in both arms and all subsequent in-hospital and ambulatory care resources consumption will be systematically recorded during the one month follow-up period. Effectiveness will be assessed in terms of Quality-Adjusted Life-Years (QALYs) estimated from patients' answers to the Euroqol EQ-5D questionnaire and french preferences scores. Results will be presented as an incremental cost-per-QALY ratio.	3 months
Secondary	Budget impact analysis	The budget impact analysis will estimate the net financial profit (the difference between the costs incurred and profits obtained, or avoided costs) in developing the ambulatory surgery in the management of PAD. The perspective adopted will be that of the health care facilities and of the National health insurance. This analysis will be conducted in a 5 years time horizon to consider a full exploitation of the potential for substitution between conventional hospitalisation and ambulatory hospitalisation for eligible patients.	5 years
Secondary	Complication rates	The major vascular complications that can occur within 30 days are: Complications Intraoperative, Hematoma, Bleeding from the groin, arteriovenous fistula, Pseudo aneurysm, retroperitoneal hemorrhage, Critical Ischemia, Infection, Thrombosis.	1 month
Secondary	Functional improvement	The assessment of the functional improvement will be performed with Rutherford Classification.	1 month
Secondary	Time period to back-to-work	The time period to back-to-work will be assessed through the measurement of the duration of sick leave for people who work.	1 month