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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Treatment of Occlusive Arterial Disease
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Outpatient hospitalization, Randomized trial, Peripheral arterial disease, Endovascular treatment, Health Economics

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Outpatient hospitalisation

Conventional inpatient hospitalisation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Functional improvement
The assessment of the functional improvement will be performed with Rutherford Classification.
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.

Full Information

First Posted
October 19, 2015
Last Updated
November 5, 2019
Sponsor
Nantes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02581150
Brief Title
Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease
Acronym
AMBUVASC
Official Title
Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Outpatient hospitalization, Randomized trial, Peripheral arterial disease, Endovascular treatment, Health Economics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient hospitalisation
Arm Type
Other
Arm Description
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.
Arm Title
Conventional inpatient hospitalisation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Treatment of Occlusive Arterial Disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Budget impact analysis
Description
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.
Time Frame
5 years
Title
Complication rates
Description
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.
Time Frame
1 month
Title
Functional improvement
Description
The assessment of the functional improvement will be performed with Rutherford Classification.
Time Frame
1 month
Title
Time period to back-to-work
Description
The time period to back-to-work will be assessed through the measurement of the duration of sick leave for people who work.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann Gouëffic, Md., PhD.
Organizational Affiliation
University Hospital of Nantes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Besançon University Hospital
City
Besançon
Country
France
Facility Name
Colmar Hospital
City
Colmar
Country
France
Facility Name
Dijon University Hospital
City
Dijon
Country
France
Facility Name
Clinique de Fontaine
City
Fontaine les Dijon
Country
France
Facility Name
La Roche sur Yon Hospital
City
La Roche sur Yon
Country
France
Facility Name
Marseille University Hospital (La Timone)
City
Marseille
Country
France
Facility Name
Marseille University Hospital (North)
City
Marseille
Country
France
Facility Name
Nantes University Hospital
City
Nantes
Country
France
Facility Name
Rennes University Hospital
City
Rennes
Country
France
Facility Name
Rouen Clinique de l'Europe
City
Rouen
Country
France
Facility Name
Saint-Etienne University Hospital
City
Saint-Etienne
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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