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NCT Number: NCT02581150

Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Besançon University Hospital, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of Occlusive Arterial Disease

Procedure

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 outcomes

  1. Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms

    Time frame: 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 outcomes

  1. Budget impact analysis

    Time frame: 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.

  2. Complication rates

    Time frame: 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.

  3. Functional improvement

    Time frame: 1 month

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

  4. Time period to back-to-work

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: AMBUVASC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2015
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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