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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02581150

Collaborator

Ministry of Health, France (Other)

160

Enrollment

Locations

Arms

Duration (Months)

14.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Procedure: Treatment of Occlusive Arterial Disease	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms [3 months]
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.

Secondary Outcome Measures

Budget impact analysis [5 years]
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.
Complication rates [1 month]
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.
Functional improvement [1 month]
The assessment of the functional improvement will be performed with Rutherford Classification.
Time period to back-to-work [1 month]
The time period to back-to-work will be assessed through the measurement of the duration of sick leave for people who work.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Besançon University Hospital	Besançon	France
2	Colmar Hospital	Colmar	France
3	Dijon University Hospital	Dijon	France
4	Clinique de Fontaine	Fontaine les Dijon	France
5	La Roche sur Yon Hospital	La Roche sur Yon	France
6	Marseille University Hospital (La Timone)	Marseille	France
7	Marseille University Hospital (North)	Marseille	France
8	Nantes University Hospital	Nantes	France
9	Rennes University Hospital	Rennes	France
10	Rouen Clinique de l'Europe	Rouen	France
11	Saint-Etienne University Hospital	Saint-Etienne	France