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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Treatment of Occlusive Arterial Disease

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Outpatient hospitalisation; The intervention is the Treatment of Occlusive Arterial Disease, during an ambulatory hospitalisation, with the use of an arterial closure device (ACD). The patients treated for PAD (Peripheral Arterial Disease) are informed and prepared in the morning of D0. The surgical endovascular procedure is performed at D0 before 1:00 p.m. The patients leave the hospital in the evening at D0 after a systematic visit.	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.
OTHER: Conventional inpatient hospitalisation; The intervention is the Treatment of Occlusive Arterial Disease, during a conventional hospitalisation, with or without ACD (ACD will be used at the discretion of the interventionalist). The patients treated for PAD arrive at the hospital the day before surgery (D-1). The surgical endovascular procedure takes place the next day (D0). The day after (D1), the patients leave the hospital after a systematic visit.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Functional improvement	The assessment of the functional improvement will be performed with Rutherford Classification.	1 month
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Yann Gouëffic, Md., PhD., University Hospital of Nantes, France

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (ESTIMATE): October 20, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Randomized trial; Endovascular treatment; Health Economics; Outpatient hospitalization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: RC15_0044; PRME-14-0444 (OTHER_GRANT: French Minstry of Health)